Caregiver mental health is linked to early childhood development, yet more robust evidence of community-based interventions to prevent maternal depression and optimize socio-emotional development of young children is needed. Objectives of this cluster-randomized controlled trial (cRCT), based in Northern Ghana, are to assess the impact of the lay counselor-delivered, group-based Integrated Mothers and Babies Course and Early Childhood Development (iMBC/ECD) program on (1) the mental health of mothers of children under age 2; and (2) the socio-emotional development of their children.

This cRCT randomized 32 women's groups – 16 received iMBC/ECD content (intervention) and 16 received general health education content (control). Surveys were administered at baseline, immediate post-intervention, and 8-month post-intervention. The primary outcome was maternal depression [Patient Health Questionnaire (PHQ-9)], and the secondary outcome was child's socio-emotional development [Ages and Stages Questionnaire: Social Emotional (ASQ:SE-2)]. Qualitative interviews with 33 stakeholders were also conducted.

In total, 374 participants were enrolled at baseline while pregnant with the index child, 19% endorsing moderate/severe depression. Of these, 266 (71.1%) completed the 8-month post-intervention survey (~19 months post-baseline). There were no significant effects of iMBC/ECD on PHQ-9 and ASQ:SE-2 scores. However, results favored the intervention arm in most cases. iMBC participants were highly satisfied with the program but qualitative feedback from stakeholders indicated some implementation challenges.

This real-world evaluation had null findings; however, post-intervention depression levels were very low in both arms (3%). Future research should examine the potential impact of women's groups on postpartum mental health more broadly with varying content.