Early Childhood Development Clinical Trial
Official title:
Evaluation of the iMBC/ECD Model on Maternal Mental Health and Child Development in Ghana
Verified date | July 2020 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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.) |
Country | Name | City | State |
---|---|---|---|
Ghana | Catholic Relief Services | Tamale |
Lead Sponsor | Collaborator |
---|---|
Duke University | Catholic Relief Services |
Ghana,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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