Evaluation of the iMBC/ECD Model in Ghana
- Conditions
- Early Childhood Development
- Interventions
- Behavioral: Integrated Mothers and Babies Course
- Registration Number
- NCT03665246
- Lead Sponsor
- Duke University
- Brief Summary
The Duke research team will work with Catholic Relief Services (CRS) and lead the design and implementation of a cluster-randomized trial in Northern Ghana to assess the impact of the Integrated Mothers and Babies Course \& Early Childhood Development (iMBC/ECD) intervention on the mental wellbeing of mothers of children under 2 and their children's attainment of age-appropriate developmental milestones.
- Detailed Description
Maternal psychological disorders around the time of pregnancy and childbirth have been identified as a key risk factor for poor child development outcomes in growth, cognition, and overall child health in low- and middle-income countries (LMICs). Maternal depression during a child's infancy predicts negative behavior and lower achievement scores, as well as increased absences in elementary school), and has been identified as a significant risk factor for poor infant growth in the developing world. There is considerable evidence to suggest that a community-based intervention, delivered by trained community volunteers, can have a significant impact on perinatal depression and child development outcomes. This cluster-randomized trial in Northern Ghana will assess the impact of the Integrated Mothers and Babies Course \& Early Childhood Development (iMBC/ECD) intervention on the mental wellbeing of mothers of children under 2 and their children's attainment of age-appropriate developmental milestones. In Ghana, the iMBC/ECD will be implemented in the context of the Rural Emergency Health Service and Transport project (REST II). A key activity of REST II is Community Pregnancy Surveillance and Targeted Education Sessions (C-PrES). Routine C-PrES is delivered via educational group sessions that promote the adoption of key Maternal, Neonatal and Child Health and Nutrition (MNCHN) behaviors (e.g. newborn care, exclusive breastfeeding, etc.) among pregnant women and mothers of children under age two.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 378
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention (iMBC/ECD + C-PrES) Integrated Mothers and Babies Course The intervention group of women/children dyads who consent will receive 14 sessions of the Integrated Mothers and Babies Course/Early Childhood Development (iMBC/ECD) curriculum in addition to the C-PrES curriculum. Upon completion of 14 sessions, women will continue to receive MNCHN and ECD messages and group-based iMBC booster sessions every 3 months.
- Primary Outcome Measures
Name Time Method Maternal Depression/Anxiety 6 months post-intervention The 9 item Patient Health Questionnaire (PHQ-9) will be used to asses the mental health (depression) of mothers of children under 2. The PHQ-9 score ranges from 0-27, with higher numbers indicating higher levels of depression.
Age-appropriate Social-Emotional Development of Children Under 2 Years 6 months post-intervention The Ages and Stages Questionnaire:Social Emotional-2 (ASQ: SE-2) will be used to assess the attainment of age-appropriate social emotional development. The questionnaire that is administered is based on the child's age in completed months:
* ASQ:SE 2 Month Questionnaire: 1 month 0 days - 2 months 30 days
* ASQ:SE 6 Month Questionnaire: 3 month 0 days - 8 months 30 days
* ASQ:SE 12 Month Questionnaire: 9 months 0 days - 14 months 30 days
* ASQ:SE 18 Month Questionnaire: 15 months 0 days - 20 months 30 days
* ASQ:SE 24 Month Questionnaire: 21 months 0 days - 26 months 30 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Catholic Relief Services
🇬ðŸ‡Tamale, Ghana