Remote Collaborative Depression Care Program for Adolescents in Araucanía Region, Chile: Randomized Controlled Trial

Background Despite evidence on efficacious interventions, a great proportion of depressed adolescents do not receive evidence-based treatment and have no access to specialized mental health care. Remote collaborative depression care (RCDC) may help to reduce the gap between needs and specialized mental health services. Objective The objective of this study was to assess the feasibility, acceptability, and effectiveness of an RCDC intervention for adolescents with major depressive disorder (MDD) living in the Araucanía Region, Chile. Methods A cluster randomized, assessor-blind trial was carried out at 16 primary care centers in the Araucanía Region, Chile. Before randomization, all participating primary care teams were trained in clinical guidelines for the treatment of adolescent depression. Adolescents (N=143; 13-19 years) with MDD were recruited. The intervention group (RCDC, N=65) received a 3-month RCDC treatment that included continuous remote supervision by psychiatrists located in Santiago, Chile’s capital city, through shared electronic health records (SEHR) and phone patient monitoring. The control group (enhanced usual care or EUC; N=78) received EUC by clinicians who were encouraged to follow clinical guidelines. Recruitment and response rates and the use of the SEHR system were registered; patient adherence and satisfaction with the treatment and clinician satisfaction with RCDC were assessed at 12-week follow-up; and depressive symptoms and health-related quality of life (HRQoL) were evaluated at baseline and 12-weeks follow-up. Results More than 60.3% (143/237) of the original estimated sample size was recruited, and a response rate of 90.9% (130/143) was achieved at 12-week follow-up. A mean (SD) of 3.5 (4.0) messages per patient were written on the SEHR system by primary care teams. A third of the patients showed an optimal adherence to psychopharmacological treatment, and adolescents in the RCDC intervention group were more satisfied with psychological assistance than those in EUC group. Primary care clinicians were satisfied with the RCDC intervention, valuing its usefulness. There were no significant differences in depressive symptoms or HRQoL between groups. Satisfaction with psychological care, in both groups, was related to a significant change in depressive symptomatology at 12-weeks follow-up (beta=−4.3, 95% CI −7.2 to −1.3). Conclusions This is the first trial of its kind in Latin America that includes adolescents from vulnerable backgrounds, with an intervention that proved to be feasible and well accepted by both patients and primary care clinicians. Design and implementation issues may explain similar effectiveness across arms. The effectiveness of the intervention seems to be comparable with an already nationwide established treatment program that proved to be highly efficacious under controlled conditions. Trial Registration ClinicalTrials.gov: NCT01860443; https://clinicaltrials.gov/ct2/show/NCT01860443 (Archived by WebCite at http://www.webcitation.org/6wafMKlTY)

TITLE AND ABSTRACT 1a) TITLE: Identi㦹cation as a randomized trial in the title 1a) Does your paper address CONSORT item 1a? * I.e does the title contain the phrase "Randomized Controlled Trial"? (if not, explain the reason under "other") yes Other: 1a-i) Identify the mode of delivery in the title Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if oȻine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms. 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study "Remote Collaborative Depression Care Program". Although the title does not have the level of detail requested, we believe that it summarizes properly and synthetically the nature of a complex intervention that has two components: 1) an internetbased intervention (shared electronic health records between specialists and primary care teams); and 2) an important cointervention (telephone patient monitoring). Otherwise, the title would have been too long.

1a-ii) Non-web-based components or important co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL23O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNS… 4/38 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study "Collaborative Depression Care Program for Adolescents". This is an intervention for adolescents with major depressive disorder.
1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT
Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL23O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lNS… 5/38 "The intervention group (RCDC, N=65) received a threemonth RCDC treatment that included continuous remote supervision by psychiatrists located in Santiago, Chile's capital city, through shared electronic health records and phone patient monitoring. The control group (EUC, N=78) received enhanced usual care by clinicians who were encouraged to follow clinical guidelines." 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. oȻine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials 1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials Conclusions/Discussions in abstract for negative trials: Discuss the primary outcome -if the trial is negative (primary outcome not changed), and the intervention was not used, discuss whether negative results are attributable to lack of uptake and discuss reasons. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study "The present study tested the feasibility and acceptability of a remote collaborative care program delivered by primary and specialized mental health teams to enhance the management of adolescent MDD in the Araucanía Region, an underserved area of Chile." METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study "A cluster randomized, assessorblind clinical trial was carried out in the Araucanía Region, Chile." "the health centers were randomized with a 1:1 ratio in order to be assigned to the intervention or the control condition." 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study There were no important changes to methods after trial commencement.
3b-i) Bug 㦹xes, Downtimes, Content Changes Bug 㦹xes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug 㦹xes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have inuenced study design such as staff changes, system failures/downtimes, etc. [2].
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study 4a) Eligibility criteria for participants Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study "The health care teams invited adolescents between 13 and 19 years old with suspected depression to participate in the study, obtaining the informed consent of those over 18 and the informed assent of minors along with their tutors' informed consent. A child and adolescent psychiatrist in Santiago verified over the telephone that the adolescents could be diagnosed with depression and not psychotic depression, bipolar disorder, comorbidity with substances and/or alcohol dependence, or suicide risk requiring immediate specialized treatment."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari㦹ed.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL23O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lN… 10/38 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. oȻine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasianonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email con㦹rmation, phone calls) were used to detect/prevent these.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study "Adolescents between 13 and 19 years old with suspected depression were invited (facetoface) to participate in the study by their primary care teams" "Patient baseline data and outcomes at 12week followup were evaluated via telephone by a trained consultant at Universidad de Chile's Faculty of Medicine, who was blinded to treatment allocation." 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL23O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lN… 11/38 4b) Settings and locations where the data were collected Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study "Patient baseline data and outcomes at 12week followup were evaluated via telephone by a trained consultant at Universidad de Chile's Faculty of Medicine, who was blinded to treatment allocation."

4b-i) Report if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study "Patient baseline data and outcomes at 12week followup were evaluated via telephone by a trained consultant at Universidad de Chile's Faculty of Medicine, who was blinded to treatment allocation." 4b-ii) Report how institutional aȘliations are displayed Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study 5) The interventions for each group with suȘcient details to allow replication, including how and when they were actually administered 5-i) Mention names, credential, aȘliations of the developers, sponsors, and owners Mention names, credential, aȘliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conict of interest" section or mentioned elsewhere in the manuscript).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study 5-ii) Describe the history/development process Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial.
Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL23O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lN… 14/38 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing owcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti㦹c reporting.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speci㦹c group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study (RCDC) introduced electronic patient records shared between the clinicians in the Araucanía Region and the team of childadolescent mental health specialists of Universidad de Chile's Faculty of Medicine, operating via an Internet platform in a secure virtual environment provided by the Faculty. The electronic health records functioned as a discussion forum allowing for personalized, confidential, and realtime interaction between the primary care teams and the specialists in order to assist the former during the diagnostic process and the treatment of the acute phase of the pathology." subitem not at all important essential Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study primary care teams, thus providing the specialists with other elements to be included in the online assistance sessions. Enhanced Usual Care (EUC) The clinicians in the Araucanía Region centers that were randomly assigned to the control group were encouraged to follow the recommendations of the Ministry of Health of Chile for the management of adolescent depression, and also received the main conclusions of the baseline diagnostic assessment."

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum. not in the ms, or briey explain why the item is not applicable/relevant for your study 5-x) Clarify the level of human involvement Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study 5-xi) Report any prompts/reminders used Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability). There were prompts to use the internetbased component; these were emails, phone calls, or face to face remainders during meetings between specialists and primary care teams; were triggered due to lack or poor use of shared electronic health records by primary care teams; and their frequency was dependent on the quality and quantity of updated information , and the clinical profile of the patients.

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study health records, a phone monitoring system hosted by Universidad de Chile's Faculty of Medicine was implemented by a psychologist trained in Santiago to ensure the continued and standardized assessment of clinical progress, adherence to the medical and psychosocial treatment, and secondary effects in the case of patients receiving medications. This made it possible to triangulate the information obtained from the primary care teams, thus providing the specialists with other elements to be included in the online assistance sessions." 6a) Completely de㦹ned pre-speci㦹ed primary and secondary outcome measures, including how and when they were assessed Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study projected size of the sample, the cases with full outcome data at 12 weeks versus the total number of cases included in the study, and the use of electronic records shared by the primary care teams. The acceptability of the intervention was measured by comparing rates of pharmacological adherence and user satisfaction with the components of the treatment displayed by each group at 12week followup; in addition, data reflecting the satisfaction of the primary care teams with the RCDC were analyzed." 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9]. Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text 6b) Any changes to trial outcomes after the trial commenced, with reasons Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study There were no changes to trial outcomes after the trial commenced.
7a) How sample size was determined NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size Describe whether and how expected attrition was taken into account when calculating the sample size.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study 7b) When applicable, explanation of any interim analyses and stopping guidelines Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study There were no interim analyses nor prespecified stopping guidelines.
8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study This is a cluster randomized trial at the primary care center level. A simple randomization method was performed using a table of computergenerated randomnumbers.
8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study No block randomization was used due to the small number of primary care centers involved in the study and their similar characteristics.
https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL23O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lN… 21/38 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study Central randomization by a third party.
10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study A member of the research team -not in contact with the principal investigator until assignment generated the random allocation sequence, the principal investigator assigned primary care centers to interventions, and primary care teams enrolled patients.
11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study Due to the nature of the interventions, neither patients nor primary care providers were blinded. However, research personnel -who were blinded to allocation, assessed patients to obtain baseline and followup data. "Patient baseline data and outcomes at 12week followup were evaluated via telephone by a trained consultant at Universidad de Chile's Faculty of Medicine, who was blinded to treatment allocation." 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study 11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study primary care teams, thus providing the specialists with other elements to be included in the online assistance sessions. Enhanced Usual Care (EUC) The clinicians in the Araucanía Region centers that were randomly assigned to the control group were encouraged to follow the recommendations of the Ministry of Health of Chile for the management of adolescent depression, and also received the main conclusions of the baseline diagnostic assessment." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL23O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q1lN… 23/38 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study "Descriptive analyses for relevant variables were conducted for the total sample and for each group separately. Missing values were quantified. Adequate balance in outcomes and potential confounders between groups were checked. Fisher's exact test and independent samples ttest were used to compare differences in patient adherence and treatment satisfaction between groups." 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study No imputation technique was required.

12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses
Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study RESULTS 13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study able to identify 178 adolescents with suspected depression and managed to recruit 143 eligible individuals, which represents 60.3% of the initially projected sample size. 45.5% of the participants received the RCDC intervention, while 54.5% received EUC (Figure 2). At 12week followup, full outcome data were obtained for at least 90.9% of the total sample: 93.8% for the RCDC intervention and 88.5% for EUC; that were subsequently analyzed (Figure 2)." Further details are given in Figure 2. 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT ow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study Details are given in Figure 2.

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other 㦹gures or tables demonstrating usage/dose/engagement.

2 3 4 5
subitem not at all important essential Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the 㦹gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study 14a) Dates de㦹ning the periods of recruitment and followup Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study The recruitment started in August 2013, ending 22 months later. The 12 week followup ended in January 2016.
14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signi㦹cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study 14b) Why the trial ended or was stopped (early) Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study Although there were no prespecified stopping guidelines, this trial was stopped early, and did not reach its full sample size, due to the end of the research period. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study Reported in Table 1.

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study This is not applicable to the trial, since those accessing the internetbased component were health care professionals.
16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 16-i) Report multiple "denominators" and provide de㦹nitions Report multiple "denominators" and provide de㦹nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci㦹c pre-de㦹ned time points of interest (in absolute and relative numbers per group). Always clearly de㦹ne "use" of the intervention.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study Tables 2 and 3. Analyses were carried out by original assigned groups.

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% con㦹dence interval) Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study between the groups (Wilcoxon rank sum test P value = .04), with the RCDC intervention scoring higher (Table 3). In addition, patients in the active group received a mean (SD) of 3.8 (1.0) monitoring phone calls, lasting 5 10 minutes each. On a scale from 1 (worst) to 7 (best), patients assigned a mean score of (SD) 6.2 (1.2) to the usefulness of these calls and 6.2 (1.2) to how comfortable they felt with the phone monitoring." Additional information provided in Tables 2 and 3. 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational de㦹nitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is de㦹ned (e.g., timeout after idle time) [1] (report under item 6a).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study Information provided in Table 3.
18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-speci㦹ed from exploratory Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study aspects of the RCDC intervention: a) usefulness for clinical work mean score (SD) 6.3 (1.0), ranging from 3 to 7 on a scale from 1 (Worst) to 7 (Best), mode 7; b) usefulness for patients mean score 6.5 (0.7), range 47, mode 7; and c) comfort level of the Internet platform mean score 6.0 (1), range 47, mode 7. In addition, the main positive aspects, difficulties, and suggestions regarding the RCDC voiced by the primary care clinicians in the active group are summarized in Table 4."

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study

19) All important harms or unintended effects in each group
(for speci㦹c guidance see CONSORT for harms) Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study No harms or unintended effects were assessed in this study.

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2]. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study was useful and provided them with innovative tools for the comprehensive management of adolescent depression. However, over one third of the clinicians of the primary care teams had little or no participation on the Internet platform, and only one third of the patients displayed an adequate adherence to the pharmacological treatment. Complementarily, the clinicians who participated in the RCDC group identified obstacles in primary mental health care that may compromise the integrity of the intervention." Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study health care personnel, could have resulted in a level of antidepressant prescription higher than that recommended by physicians without suitable training for managing adolescent depression. In addition, it is interesting to note that one of the differences between the groups in terms of user satisfaction concerned psychological treatment, which is provided by the most stable personnel in primary care teams; therefore, psychologists could play a more relevant role in future interventions of this type." 21) Generalisability (external validity, applicability) of the trial 㦹ndings NPT: External validity of the trial 㦹ndings according to the intervention, comparators, patients, and care providers or centers involved in the trial

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study 21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study OTHER INFORMATION 23) Registration number and name of trial registry Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study "Trial registration: Clinicaltrials.gov NCT01860443." 24) Where the full trial protocol can be accessed, if available Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study No full trial protocol available. Further information may be obtained in Clinicaltrials.gov, searching for registration number NCT01860443.

25)
Sources of funding and other support (such as supply of drugs), role of funders Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study X27) Conicts of Interest (not a CONSORT item) X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests (㦹nancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briey explain why the item is not applicable/relevant for your study About the CONSORT EHEALTH checklist As a result of using this checklist, did you make changes in your manuscript? * yes, major changes yes, minor changes no What were the most important changes you made as a result of using this checklist?
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * Approximately 5 hours of work.
As a result of using this checklist, do you think your manuscript has improved? * yes no Other: Would you like to become involved in the CONSORT EHEALTH group? This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document yes no Other: Any other comments or questions on CONSORT EHEALTH STOP -Save this form as PDF before you click submit To generate a record that you 㦹lled in this form, we recommend to generate a PDF of this page (on a Mac, simply select "print" and then select "print as PDF") before you submit it.
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