UNSTRUCTURED Background: Colombia is a middle-income country in South America which has historically struggled with 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-centred intervention that can potentially improve the delivery of care and quality of life for adolescents with mental health problems. This exploratory randomised 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: Eighteen clinicians and 108 adolescents will be recruited from primary healthcare services located in Bogota and Duitama, Colombia. Clinicians will be randomised in a 2:1 radio to either the intervention (12 clinicians/72 adolescents) or to the control group (6 clinicians/36 adolescents). In the intervention arm, clinicians will use DIALOG-A with adolescents monthly over 6 months. The control arm will continue to receive routine care. Outcomes will be measured at baseline, 6- and 9-months following randomisation. Semi-structured 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. Discussion: 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 number and date: ISRCTN13980767 (18/03/2022)

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