- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03195036
Evaluation of an Early Childhood Development Intervention for HIV-Exposed Children in Cameroon
October 10, 2019 updated by: Joy Noel Baumgartner, Duke University
There is substantial evidence that early childhood development (ECD) programming can improve child health and development outcomes.
An important component of ECD programming is supporting positive parenting and early stimulation practices.
While many parents could benefit from such programming, mothers that are HIV-infected may particularly benefit given the higher risks of poorer child development among HIV-exposed children.
Catholic Relief Services (CRS) in Cameroon is implementing the Key Interventions to Develop Systems and Services (KIDSS) ECD program for HIV-exposed children.
This impact evaluation will ascertain to what extent the KIDSS home-based component of the ECD model affects attainment of age-appropriate developmental milestones (measured by the Ages and Stages Questionnaire 3 (ASQ-3)) in HIV-exposed children in Cameroon.
The study design is a cluster-randomized controlled trial with a cohort of 200 mother/child dyads across 10 study clinics.
HIV+ mothers will be recruited during pregnancy and their children will be followed up until 18 months of age.
The intervention group will receive regular home-based ECD services focused on positive parenting and early stimulation.
The control group will not have any exposure to ECD services, though they may receive home-based services focused on HIV care and treatment, hygiene, and nutrition.
Randomization occurs at the clinic (cluster) level.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
230
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Yaoundé, Cameroon
- Catholic Relief Services
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- HIV-positive
- Pregnant and currently in 3rd trimester
- Must reside in Nkoldongo district or Djoungolo district
- Willing to be followed up for up to 21 months (pregnancy + postpartum periods)
- Agrees to voluntary participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
The control group of women/children dyads who consent and are patients at the control clinics will not have any exposure to ECD programming.
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Experimental: Intervention Arm
The intervention group of women/children dyads who consent and are patients at the intervention clinics will receive regular home-based ECD services focused on positive parenting and early stimulation.
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Health facilities will be randomized to intervention and control groups.
The clients at clinics assigned to the intervention group will receive Home-based Early Childhood Development (ECD+) program.
The clients at clinics assigned to the control group will not receive the Early Childhood Development (ECD) program.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attainment of age-appropriate developmental milestones
Time Frame: ASQ-3 score assessed 18 months after birth.
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Child Development Outcomes, measured by ASQ-3 (18-month survey)
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ASQ-3 score assessed 18 months after birth.
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Attainment of age-appropriate developmental milestones
Time Frame: ASQ-3 score assessed 12 months after birth.
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Child Development Outcomes, measured by ASQ-3 (12-month survey)
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ASQ-3 score assessed 12 months after birth.
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Attainment of age-appropriate developmental milestones
Time Frame: ASQ-3 score assessed 6 months after birth.
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Child Development Outcomes, measured by ASQ-3 (6-month survey)
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ASQ-3 score assessed 6 months after birth.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attainment of age-appropriate developmental milestones
Time Frame: ASQ-SE score assessed at 18 months after birth.
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Child Development Outcomes, measured by ASQ-Social Emotional (SE)
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ASQ-SE score assessed at 18 months after birth.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Joy N Baumgartner, PhD, MSSW, Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 17, 2017
Primary Completion (Actual)
July 30, 2019
Study Completion (Actual)
July 30, 2019
Study Registration Dates
First Submitted
June 16, 2017
First Submitted That Met QC Criteria
June 20, 2017
First Posted (Actual)
June 22, 2017
Study Record Updates
Last Update Posted (Actual)
October 14, 2019
Last Update Submitted That Met QC Criteria
October 10, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- D0989
- 2017/02/867/CE/CNERSH/SP (Other Identifier: Comite National d'Ethique de la Recherche pour la Sante Hum.)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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