Project ASPIRE: A feasibility randomized controlled trial of a brief intervention for reducing risk of depression and alcohol-related harms among South African adolescents

Abstract

Objective:

Brief interventions could reduce adolescents’ risk of depression and alcohol-related harms, but evidence of their feasibility and acceptability for low-and middle-income countries is lacking. To address this gap, we conducted a feasibility trial of the ASPIRE intervention, a four-session multi-component counselling intervention for South African adolescents.

Method:

We recruited 117 adolescents who met our inclusion criteria. Participants were randomly assigned to the ASPIRE intervention or a comparison condition. Outcomes were assessed at baseline, six-week, and three-month post-randomization time points. Primary outcomes were based on feasibility of study procedures and intervention delivery (assessed on seven predetermined progression criteria). Clinical outcomes (risk of depression and alcohol harms) were secondary.

Results:

Despite modifications to all study procedures arising from Covid-19 restrictions, five of the seven key progression criteria were fully met, including: feasibility of data collection and outcome measures, counsellor competencies, randomization and blinding, adverse advents, and acceptability of the intervention. The progression criterion for recruitment and intervention retention were not fully met.

Conclusion:

Findings suggest that the ASPIRE intervention was generally feasible to deliver and acceptable to adolescents. However, modifications to the trial design and intervention delivery are needed to optimize the validity of a definitive randomized controlled trial of the ASPIRE intervention.

Keywords:

• adolescents
• low-and-middle-income country
• global mental health
• psychological intervention

Acknowledgements

We acknowledge the project counsellors, Mr. Yuche Jacobs, Ms. Ziyanda Magwentshu and Ms Siphokazi Gusana for their dedication to the participants and the intervention. We acknowledge our field staff, Ms Liesl Izaks, Ms Thembisa Ngxukuma and Ms Zoleka Maqina for their hard work in recruiting participants, conducting assessments, and retaining participants in the study.

Disclosure Statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

This study was funded by a Joint Global Health Trials development trial funded by the UK Department of Health and Social Care (DHSC), the Foreign, Commonwealth & Development Office (FCDO), the Medical Research Council (MRC) and Wellcome (Grant number MR/R018464/1).