Evaluation of the iMBC/ECD Model in Ghana

NCT03665246 | Completed

• 1 other identifier: 2019-0020
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Childhood Development

Keywords

ECD; maternal mental health; early childhood development; Ghana; ASQ; SRQ20; Integrated Mothers and Babies Course; maternal and child health

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Intervention (iMBC/ECD + C-PrES)

EXPERIMENTAL

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

Control (C-PrES)

NO INTERVENTION

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.

Interventions

Integrated Mothers and Babies Course BEHAVIORAL

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.

Intervention (iMBC/ECD + C-PrES)

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

Sponsors & Collaborators

• Duke University: lead
• Catholic Relief Services: collaborator

Study Sites (1)

Catholic Relief Services

Tamale, Ghana

Location

Related Publications (2)

• 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.

  PMID: 34736452 DERIVED

• 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.

  PMID: 33397319 DERIVED

Study Officials

• Joy Noel Baumgartner, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: September 11, 2018
• Study Start: August 29, 2018
• Primary Completion: February 26, 2020
• Study Completion: February 26, 2020
• Last Updated: July 24, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)