BACKGROUND
Adolescents with depression or anxiety initiate mental health treatment in low numbers due to multiple factors, with a top reason being negative attitudes towards treatment. We developed a peer-support website intervention, Supporting Our Valued Adolescents (SOVA), for adolescents seen in primary care settings and their parents with the goal of increasing treatment uptake through changing negative health beliefs, enhancing knowledge, offering peer emotional support, and increasing parent-adolescent communication about mental health.
OBJECTIVE
The aim of this pilot study was to refine recruitment and retention strategies, document intervention fidelity, and explore change in study outcomes (primary outcome being treatment uptake).
METHODS
We conducted a two-group, single blind, pilot randomized controlled trial in a single adolescent medicine clinic. Participants were aged 12 to 19 with clinician-identified symptoms of depression or anxiety for which a health care provider recommends treatment. The patient and parent, if interested, were randomized to receive the SOVA websites and Enhanced Usual Care (EUC) compared to EUC alone. Baseline, 6-week, and 3-month measures were collected by web-based self-report survey and blinded electronic health record review. Main pilot outcomes assessed were feasibility of recruitment and retention strategies. Implementation outcomes, intervention fidelity, missingness, and adequacy of safety protocols were documented. Descriptive statistics were used to summarize mental health service use, and target measures (examine change in health beliefs and knowledge, emotional support, and parent-adolescent communication) using 2-sample t tests to compare differences between arms.
RESULTS
A little under half of adolescents offered patient education material (195/461; 42%) were referred by their clinician to the study. Of 146 adolescents meeting inclusion criteria, 38 completed the baseline survey, qualifying them for randomization, and 25 (66%; 95% CI 51 - 81%) completed 6-week measures. There was limited engagement in the treatment arm with (5/11) 45% of adolescents who completed 6-week measures reporting accessing SOVA, mostly citing forgetting. Changes were found in target factors at 6-weeks, but not in per protocol analyses. Despite this, at 12 weeks, 15/18 (83%) adolescents randomized to SOVA received mental health treatment as compared to 10/20 (50%) adolescents randomized to EUC (P=.03), where receipt of treatment was measured by combined adolescent or parent self-report and a blinded manual EHR extraction.
CONCLUSIONS
In this pilot trial of a peer-support website intervention for adolescents with depression or anxiety we found lower than expected study enrollment post recruitment. While generalizability may be enhanced by not requiring parental permission for adolescent participation in trials of mental health interventions, this may limit study recruitment and retention. We found implementing patient education introducing the study into provider workflow was feasible and acceptable, resulting in almost 500 study referrals. Lastly, we found preliminary evidence that the SOVA intervention may increase uptake of mental health treatment as compared to usual care.
CLINICALTRIAL
ClinicalTrials.gov NCT03318666; https://clinicaltrials.gov/ct2/show/NCT03318666
INTERNATIONAL REGISTERED REPORT
RR2-10.2196/12117
