Evaluation of the iMBC/ECD Model in Ghana

Early Childhood Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03665246
• Other study ID #: 2019-0020
• Status: Completed
• Phase: N/A
• Start date: August 29, 2018
• Est. completion date: February 26, 2020

Study information

• Verified date: July 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 378
• Est. completion date: February 26, 2020
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Early Childhood Development

Intervention

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.

Locations

Country	Name	City	State
Ghana	Catholic Relief Services	Tamale

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Catholic Relief Services

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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