Supporting the mental health of adolescent mothers in Kenya and Mozambique: pilot protocol for the Thriving Mamas programme.

Background: Poor mental health among adolescent girls during pregnancy and the year after birth (the perinatal period) has been found to have a significant detrimental effect on girls and their children. The Innovative approaches to adolescent perinatal wellbeing (INSPIRE) project co-designed an intervention (Thriving Mamas) to improve adolescent perinatal mental health in Kenya and Mozambique. The aim of the current study is to pilot test the co-designed intervention to understand how it can be adapted for further testing or scale-up.

Methods: A mixed-method, pilot cluster-randomised, effectiveness-implementation Hybrid Type II trial will be conducted among 80 adolescent girls (aged 15-19 years) attending health facilities in Kenya and Mozambique. Girls attending health facilities randomised to the intervention arm will be recruited to receive the intervention in addition to usual care. Girls attending control arm facilities will receive usual care only. Implementation data on feasibility, acceptability, appropriateness, and fidelity of intervention training and delivery will be collected from providers and adolescents. Additional data on provider knowledge, attitudes, and competency will be collected pre- and post-training. Adolescent girls will provide assessments of depression, anxiety, quality of life, social support, parenting competency, and health behaviours before, during, and after delivery of the intervention. At the end of the study, qualitative interviews will be conducted to collect further data on perceptions of the intervention, its implementation, and its impact. Implementation data will be analysed to determine its potential for delivery and success within each context. Individual outcome data analyses will be reported to gain a better understanding of the initial impact of the intervention.

Discussion: The Thriving Mamas intervention addresses the challenges to maintaining positive mental health during the perinatal period. It was co-designed with adolescents and their communities to address local priorities and needs. The results of this study will provide information on its potential for sustainable implementation as well as initial data on its impact on mental health, parenting, and health behaviour outcomes. These results will inform the further refinement of the intervention and implementation strategies as well as the design of a full trial to test their effectiveness.

Trial registration: Ethical approval for this feasibility study has been obtained in Kenya (Aga Khan University Institutional Scientific and Ethics Review Committee, ref: 2023/ISERC-23 (v2)), Mozambique ( Tete Inter-Institutional Health Bioethics Committee, ref: 24/CIBST/23), and the UK (Psychiatry, Nursing and Midwifery Research Ethics Committee, King's College London, ref: HR/DP-22/23-37,125). It was registered at Clinicaltrials.gov (NCT06040359) on September 15, 2023 ( https://clinicaltrials.gov/study/NCT06040359?intr=Thriving%20mamas&rank=1  ), prior to the beginning of the study.