Evaluation of the iMBC/ECD Model in Ghana

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

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.

Study Overview

• Status: Completed
• Conditions: Early Childhood Development
• Intervention / Treatment: Behavioral: Integrated Mothers and Babies Course

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.

• Study Type: Interventional
• Enrollment (Actual): 378
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ghana
  • Tamale, Ghana
    • Catholic Relief Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention (iMBC/ECD + C-PrES); 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; 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.
No Intervention: Control (C-PrES); 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?

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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Catholic Relief Services
• Investigators: Principal Investigator: Joy Noel Baumgartner, PhD, Duke University

Publications and helpful links

General Publications

• Cao J, Gallis JA, Ali M, Lillie M, Abubakr-Bibilazu S, Adam H, McEwan E, Awoonor-Williams JK, Hembling J, Baumgartner JN. The impact of a maternal mental health intervention on intimate partner violence in Northern Ghana and the mediating roles of social support and couple communication: secondary analysis of a cluster randomized controlled trial. BMC Public Health. 2021 Nov 4;21(1):2010. doi: 10.1186/s12889-021-12121-9.
• Mackness J, Gallis JA, Owusu RK, Ali M, Abubakr-Bibilazu S, Adam H, Aborigo R, Awoonor-Williams JK, Lillie M, McEwan E, Hembling J, Vasudevan L, Baumgartner JN. Prevalence and correlates of maternal early stimulation behaviors during pregnancy in northern Ghana: a cross-sectional survey. BMC Pregnancy Childbirth. 2021 Jan 4;21(1):4. doi: 10.1186/s12884-020-03476-9.

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2018
• Primary Completion (Actual): February 26, 2020
• Study Completion (Actual): February 26, 2020

Study Registration Dates

• First Submitted: August 20, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (Actual): September 11, 2018

Study Record Updates

• Last Update Posted (Actual): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 23, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: maternal mental health; maternal and child health; Ghana; early childhood development; ECD; ASQ; SRQ20; Integrated Mothers and Babies Course
• Other Study ID Numbers: 2019-0020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No