Clinical trial NCT03665246: Evaluation of the iMBC/ECD Model in Ghana
Official title: Evaluation of the iMBC/ECD Model on Maternal Mental Health and Child Development in Ghana
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Childhood Development
Keywords: ECD
maternal mental health
early childhood development
Ghana
ASQ
SRQ20
Integrated Mothers and Babies Course
maternal and child health
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Catholic Relief Services
First posted: 2018-09-11
Enrollment: 378
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Age-appropriate Social-Emotional Development of Children Under 2 Years
timeFrame: 6 months post-intervention
measure: Maternal Depression/Anxiety
timeFrame: 6 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Tamale
country: Ghana
facility: Catholic Relief Services
Study officials:
affiliation: Duke University
name: Joy Noel Baumgartner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.