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Evaluation of the iMBC/ECD Model in Ghana

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ClinicalTrials.gov Identifier: NCT03665246
Recruitment Status : Active, not recruiting
First Posted : September 11, 2018
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
Catholic Relief Services
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Early Childhood Development Behavioral: Integrated Mothers and Babies Course Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 378 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of the iMBC/ECD Model on Maternal Mental Health and Child Development in Ghana
Actual Study Start Date : August 29, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Age-appropriate Developmental Milestones of Children Under 2 Years [ Time Frame: Pre-Intervention ]
    The Ages and Stages Questionnaire-3 (ASQ-3) will be used to assess the attainment of age-appropriate developmental milestones of children under 2 years. The ASQ-3 is split into sections: Communication, Gross Motor, Fine Motor, Problem Solving, and Personal/Social. Scores from each category can range from 0-60 with higher scores indicating appropriate development.

  2. Maternal Depression/Anxiety [ Time Frame: Pre-intervention ]
    The Self Reporting Questionnaire (SRQ-20) will be used to asses the mental health (depression/anxiety) of mothers of children under 2. The SRQ-20 score ranges from 1-20, with higher numbers indicating higher levels of depression and anxiety.

  3. Age-appropriate Developmental Milestones of Children Under 2 Years [ Time Frame: Immediate Post-Intervention ]
    The Ages and Stages Questionnaire-3 (ASQ-3) will be used to assess the attainment of age-appropriate developmental milestones of children under 2 years. The ASQ-3 is split into sections: Communication, Gross Motor, Fine Motor, Problem Solving, and Personal/Social. Scores from each category can range from 0-60 with higher scores indicating appropriate development.

  4. Maternal Depression/Anxiety [ Time Frame: Immediate Post-Intervention ]
    The Self Reporting Questionnaire (SRQ-20) will be used to asses the mental health (depression/anxiety) of mothers of children under 2. The SRQ-20 score ranges from 1-20, with higher numbers indicating higher levels of depression and anxiety.

  5. Age-appropriate Developmental Milestones of Children Under 2 Years [ Time Frame: 6 months post-intervention ]
    The Ages and Stages Questionnaire-3 (ASQ-3) will be used to assess the attainment of age-appropriate developmental milestones of children under 2 years. The ASQ-3 is split into sections: Communication, Gross Motor, Fine Motor, Problem Solving, and Personal/Social. Scores from each category can range from 0-60 with higher scores indicating appropriate development.

  6. Maternal Depression/Anxiety [ Time Frame: 6 months post-intervention ]
    The Self Reporting Questionnaire (SRQ-20) will be used to asses the mental health (depression/anxiety) of mothers of children under 2. The SRQ-20 score ranges from 1-20, with higher numbers indicating higher levels of depression and anxiety.

  7. Age-appropriate Developmental Milestones of Children Under 2 Years [ Time Frame: 9 months post-intervention ]
    The Ages and Stages Questionnaire-3 (ASQ-3) will be used to assess the attainment of age-appropriate developmental milestones of children under 2 years. The ASQ-3 is split into sections: Communication, Gross Motor, Fine Motor, Problem Solving, and Personal/Social. Scores from each category can range from 0-60 with higher scores indicating appropriate development.

  8. Maternal Depression/Anxiety [ Time Frame: 9 months post-intervention ]
    The Self Reporting Questionnaire (SRQ-20) will be used to asses the mental health (depression/anxiety) of mothers of children under 2. The SRQ-20 score ranges from 1-20, with higher numbers indicating higher levels of depression and anxiety.


Secondary Outcome Measures :
  1. Uptake of ECD Behaviors [ Time Frame: Pre-intervention ]
    Questions for children under 5 from the Multiple Indicator Cluster Surveys(MICS) will be used to assess the uptake of select ECD behaviors of mothers with children under 2.

  2. Uptake of ECD Behaviors [ Time Frame: Immediate post-intervention ]
    Questions for children under 5 from the Multiple Indicator Cluster Surveys(MICS) will be used to assess the uptake of select ECD behaviors of mothers with children under 2.

  3. Uptake of ECD Behaviors [ Time Frame: 6 months post-intervention ]
    Questions for children under 5 from the Multiple Indicator Cluster Surveys(MICS) will be used to assess the uptake of select ECD behaviors of mothers with children under 2.

  4. Uptake of ECD Behaviors [ Time Frame: 9 months post-intervention ]
    Questions for children under 5 from the Multiple Indicator Cluster Surveys(MICS) will be used to assess the uptake of select ECD behaviors of mothers with children under 2.

  5. Relationships between Mothers and Romantic Partners [ Time Frame: Pre-intervention, Immediate post-intervention, 6 month post-intervention, 9 month post-intervention ]
    The Couple Functionality Assessment (CFAT) will be used to assess relationship quality between the participant and her partner. The total score ranges from 0 to 100 with higher scores indicating a higher quality relationship. We will additionally use questions from the Ghana Demographic and Health surveys to assess domestic violence between the participant and her partner.

  6. Relationships between Mothers and Romantic Partners [ Time Frame: Pre-intervention ]
    The Couple Functionality Assessment (CFAT) will be used to assess relationship quality between the participant and her partner. The total score ranges from 0 to 100 with higher scores indicating a higher quality relationship. We will additionally use questions from the Ghana Demographic and Health surveys to assess domestic violence between the participant and her partner.

  7. Relationships between Mothers and Romantic Partners [ Time Frame: Immediate Post-Intervention ]
    The Couple Functionality Assessment (CFAT) will be used to assess relationship quality between the participant and her partner. The total score ranges from 0 to 100 with higher scores indicating a higher quality relationship. We will additionally use questions from the Ghana Demographic and Health surveys to assess domestic violence between the participant and her partner.

  8. Relationships between Mothers and Romantic Partners [ Time Frame: 6 Month Post-Intervention ]
    The Couple Functionality Assessment (CFAT) will be used to assess relationship quality between the participant and her partner. The total score ranges from 0 to 100 with higher scores indicating a higher quality relationship. We will additionally use questions from the Ghana Demographic and Health surveys to assess domestic violence between the participant and her partner.

  9. Relationships between Mothers and Romantic Partners [ Time Frame: 9 Month Post-Intervention ]
    The Couple Functionality Assessment (CFAT) will be used to assess relationship quality between the participant and her partner. The total score ranges from 0 to 100 with higher scores indicating a higher quality relationship. We will additionally use questions from the Ghana Demographic and Health surveys to assess domestic violence between the participant and her partner.

  10. Health Service Utilization [ Time Frame: Pre-intervention ]
    Questions from the Ghana Demographic and Health Surveys (DHS) about antenatal and postnatal care will be used to determine the uptake of health services by mothers with children under 2.

  11. Health Service Utilization [ Time Frame: Immediate Post-Intervention ]
    Questions from the Ghana Demographic and Health Surveys (DHS) about antenatal and postnatal care will be used to determine the uptake of health services by mothers with children under 2.

  12. Health Service Utilization [ Time Frame: 6 Month Post Intervention ]
    Questions from the Ghana Demographic and Health Surveys (DHS) about antenatal and postnatal care will be used to determine the uptake of health services by mothers with children under 2.

  13. Health Service Utilization [ Time Frame: 9 Month Post Intervention ]
    Questions from the Ghana Demographic and Health Surveys (DHS) about antenatal and postnatal care will be used to determine the uptake of health services by mothers with children under 2.


Other Outcome Measures:
  1. Hope [ Time Frame: Pre-intervention ]
    The Herth Hope Index will be used to assess degrees of hopefulness in mothers with children under 2.The total score ranges from 0 to 90 and a higher score indicates a higher level of hope.

  2. Hope [ Time Frame: Immediate Post-Intervention ]
    The Herth Hope Index will be used to assess degrees of hopefulness in mothers with children under 2.The total score ranges from 0 to 90 and a higher score indicates a higher level of hope.

  3. Hope [ Time Frame: 6 Month Post-Intervention ]
    The Herth Hope Index will be used to assess degrees of hopefulness in mothers with children under 2.The total score ranges from 0 to 90 and a higher score indicates a higher level of hope.

  4. Hope [ Time Frame: 9 Month Post-Intervention ]
    The Herth Hope Index will be used to assess degrees of hopefulness in mothers with children under 2.The total score ranges from 0 to 90 and a higher score indicates a higher level of hope.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665246


Locations
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Ghana
Catholic Relief Services
Tamale, Ghana
Sponsors and Collaborators
Duke University
Catholic Relief Services
Investigators
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Principal Investigator: Joy Noel Baumgartner, PhD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03665246     History of Changes
Other Study ID Numbers: 2019-0020
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Duke University:
ECD
maternal mental health
early childhood development
Ghana
ASQ
SRQ20
Integrated Mothers and Babies Course
maternal and child health