CompletedNot Applicable

Evaluation of the iMBC/ECD Model in Ghana

Ghana378 participantsStarted 2018-08-29

Plain-language 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.

Who can participate

Age range

16 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 6 months post-intervention

Maternal Depression/Anxiety

Timeframe: 6 months post-intervention

Trial details

NCT IDNCT03665246

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-26

View on ClinicalTrials.gov More Early Childhood Development trials