Implementing combined WHO mhGAP and adapted group interpersonal psychotherapy to address depression and mental health needs of pregnant adolescents in Kenyan primary health care settings (INSPIRE): a study protocol for pilot feasibility trial of the integrated intervention in LMIC settings.

Background: Addressing adolescent pregnancies associated health burden demands new ways of organizing maternal and child mental health services to meet multiple needs of this group. There is a need to strengthen integration of sustainable evidence-based mental health interventions in primary health care settings for pregnant adolescents. The proposed study is guided by implementation science frameworks with key objective of implementing a pilot trial testing a full IPT-G version along with IPT-G mini version under the mhGAP/IPT-G service framework and to study feasibility of the integrated mhGAP/IPT-G adolescent peripartum depression care delivery model and estimate if a low cost and compressed version of IPT-G intervention would result in similar size of effect on mental health and family functioning as the Full IPT-G. There are two sub- studies embedded which are: 1) To identify multi-level system implementation barriers and strategies guided by the Consolidated Framework for Implementation Research (CFIR) to enhance perinatal mhGAP-depression care and evidence-based intervention integration (i.e., group interpersonal psychotherapy; IPT-G) for pregnant adolescents in primary care contexts; 2) To use findings from aim 1 and observational data from Maternal and Child Health (MCH) clinics that run within primary health care facilities to develop a mental health implementation workflow plan that has buy-in from key stakeholders, as well as to develop a modified protocol and implementation training manual for building health facility staff's capacity in implementing the integrated mhGAP/IPT-G depression care.

Methods: For the primary objective of studying feasibility of the integrated mhGAP/IPT-G depression care in MCH service context for adolescent perinatal depression, we will recruit 90 pregnant adolescents to a three-arm pilot intervention (unmasked) trial study (IPT-G Full, IPT-G Mini, and wait-list control in the context of mhGAP care). Pregnant adolescents ages 13-18, in their 1st-2nd trimester with a depression score of 13 and above on EPDS would be recruited. Proctor's implementation evaluation model will be used. Feasibility and acceptability of the intervention implementation and size of effects on mental health and family functioning will be estimated using mixed method data collection from caregivers of adolescents, adolescents, and health care providers. In the two sub-studies, stakeholders representing diverse perspectives will be recruited and focus group discussions data will be gathered. For aim 2, to build capacity for mhGAP-approach of adolescent depression care and research, the implementation-capacity training manual will be applied to train 20 providers, 12 IPT-G implementers/health workers and 16 Kenyan researchers. Acceptability and appropriateness of the training approach will be assessed. Additional feedback related to co-located service delivery model, task-shifting and task-sharing approach of IPT-G delivery will be gathered for further manual improvement.

Discussion: This intervention and service design are in line with policy priority of Government of Kenya, Kenya Vision 2030, World Health Organization, and UN Sustainable Development Goals that focus on improving capacity of mental health service systems to reduce maternal, child, adolescent health and mental health disparities in LMICs. Successfully carrying out this study in Kenya will provide an evidence-based intervention service development and implementation model for adolescents in other Sub-Saharan African (SSA) countries. The study is funded by FIC/NIH under K43 grant.