Skip to main content

Table 1 Summary table the pilot feasibility trial

From: 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

Objectives

Outcomes

Criterion for success

Method for analysis

Estimate of effect

Primary feasibility

Demonstrate that the method of RCT feasible in MCH clinical service context

70% of pregnant adolescent-caregiver-health care workers that are exposed to content of the intervention;

80% of data collection performed as planned;

Quantitative analysis for implementation outcomes will be based on data collected throughout the implementation period, and analyzed separately for each time point as well as jointly to create overall summary scores. Analysis for the MCH service outcomes will be based on pre-post intervention data using pair-t tests and repeated measures.

Quantitative data for implementation outcomes, MCH service outcomes, and adolescent mental health effectiveness outcomes will be examined separately.

Qualitative data will be transcribed and analyzed using similar techniques described in Aim 1. We will review all focus group discussion data and use grounded theory approach to search for emerging themes using open and axial coding.

Depression and family functioning will be based on multi-level modeling, adjusting for family/group nesting effects. Post-intervention effects estimated as a function of baseline levels of the corresponding outcome variables and intervention status.

Secondary outcomes

a) Identification of barriers and facilitators to mhGAP/IPT-G implementation in MCH context

b) Capacity building of MCH personnel, researchers and select MOH and County health partners

c) Adaptation of mhGAP/IPT-G

a. Identification of select mhGAP informed barriers to care and adaptation of mhGAP and IPT-G for this context

b. Capacity building will significantly improve trainees’ (nurses and community health workers) knowledge and skills in implementation research and delivering of depression intervention.

c. Adapted manual for IPT-G and algorithm for mhGAP-IG for depression for pregnant adolescents

Qualitative and ethnographic methods including mixed methods using D& I and attitudes to EBI and adolescent friendly health services

Pre and post training interviews and acceptability and satisfaction the trainings

Knowledge and fidelity trainings on mhGAP/IPT-G

N/A