Abstract
BACKGROUND: Colombia is a middle-income country in South America, which has historically had high rates of mental health problems, coupled with a scarcity of mental health care. There is growing concern for the mental health of the adolescent population within this region. There is a significant treatment gap for young people, especially those living in the most vulnerable areas. DIALOG+ is a low-cost patient-centered intervention that can potentially improve the delivery of care and quality of life for adolescents with mental health problems. OBJECTIVE: This exploratory randomized controlled trial aims to evaluate the effectiveness, acceptability, and feasibility of an adapted version of the DIALOG+ intervention (DIALOG-A) in the community treatment of Colombian adolescents with depression and anxiety. METHODS: In total, 18 clinicians and 108 adolescents will be recruited from primary health care services in Bogota and Duitama, Colombia. Clinicians will be randomized 2:1 to either the intervention (12 clinicians:72 adolescents) or control group (6 clinicians:36 adolescents). In the intervention arm, clinicians will use DIALOG-A with adolescents once per month over 6 months. The control arm will continue to receive routine care. Outcomes will be measured at baseline, 6 months, and 9 months following randomization. Semistructured interviews with all clinicians and a subset of adolescents in the intervention arm will be conducted at the end of the intervention period. Quantitative and qualitative analysis of the data will be conducted. RESULTS: Trial recruitment was completed toward the end of October 2022, and follow-up is anticipated to last through to October 2023. CONCLUSIONS: This is the first study to test an adapted resource-orientated intervention (DIALOG-A) in the treatment of adolescents with depression and anxiety attending primary care services. If the results are positive, DIALOG-A can be implemented in the routine care of adolescents with these mental health problems and provide valuable insight to other middle-income countries. TRIAL REGISTRATION: ISRCTN Registry ISRCTN13980767; https://www.isrctn.com/ISRCTN13980767?q=ISRCTN13980767. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43401.