Evaluation of the iMBC/ECD Model in Ghana

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of the iMBC/ECD Model on Maternal Mental Health and Child Development in Ghana

Conditions
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Early Childhood Development

Intervention / Treatment
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* Behavioral: Integrated Mothers and Babies Course


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (Mother): 16 years or older Currently pregnant Attends C-PrES groups at the time of the baseline survey (West Mamprusi and Nabdam District) Plan to maintain residence in the community for at least 6 months Agrees to voluntary participation (The participation of the child falls under the mother's consent. Once born, the child will be followed along with its mother as long as the mother continues participation in the study.)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The present study is a cluster randomized trial (CRT) of 32 program groups with 16 groups randomly assigned to receive the intervention program (iMBC/ECD + C-PrES) and 16 groups randomly assigned to receive the control program (C-PrES only).The main reason for including randomization is to reduce the risk of selection bias. The unit of inference for this CRT is at the individual level but the unit of randomization is the C-PrES group (cluster) level due to issues of program feasibility.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (iMBC/ECD + C-PrES)<br>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. | Behavioral: Integrated Mothers and Babies Course<br>* The Integrated Mothers and Babies Course/Early Childhood Development (iMBC/ECD) will be implemented along side normal C-PrES programming (key MNCHN behaviors). The iMBC curriculum is a prevention model based on cognitive behavioral therapy with the aim of supporting pregnant women and mothers with children under two years of age to become more resilient, decrease risk for future depression, and manage daily stressors effectively. In addition, the updated version of the iMBC is integrated with selected early childhood development (ECD) messages. The integration of these messages is intended to increase mothers' knowledge of the stressors associated with pregnancy and parenting young children and promote early stimulation behaviors and bonding to support child development.<br>|
| No Intervention: Control (C-PrES)<br>The control group of women/children dyads who consent will have exposure to 14 sessions of the C-PrES curriculum which promotes the adoption of key MNCHN behaviors (e.g. newborn care, exclusive breastfeeding, etc.). Upon completion of 14 sessions, women will continue to receive MNCHN and ECD messages. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age-appropriate Social-Emotional Development of Children Under 2 Years | 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 | 6 months post-intervention | 
| Maternal Depression/Anxiety | 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. | 6 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASQ, maternal mental health, early childhood development, Ghana, SRQ20, Integrated Mothers and Babies Course, maternal and child health, ECD