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Completed

NCT Number: NCT03665246

Evaluation of the iMBC/ECD Model 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.

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Key information

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Catholic Relief Services

Tamale, Ghana

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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.

Primary outcomes

  1. Age-appropriate Social-Emotional Development of Children Under 2 Years

    Time frame: 6 months post-intervention

    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
  2. Maternal Depression/Anxiety

    Time frame: 6 months post-intervention

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Catholic Relief Services

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 11, 2018
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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