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

Conditions

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

  • Cameroon
      • Yaoundé, Cameroon
        • Catholic Relief Services

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

14 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.
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.
Behavioral: Home-based ECD services
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:
  • KIDSS Project Home-Based Visits

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.
Child Development Outcomes, measured by ASQ-3 (18-month survey)
ASQ-3 score assessed 18 months after birth.
Attainment of age-appropriate developmental milestones
Time Frame: ASQ-3 score assessed 12 months after birth.
Child Development Outcomes, measured by ASQ-3 (12-month survey)
ASQ-3 score assessed 12 months after birth.
Attainment of age-appropriate developmental milestones
Time Frame: ASQ-3 score assessed 6 months after birth.
Child Development Outcomes, measured by ASQ-3 (6-month survey)
ASQ-3 score assessed 6 months after birth.

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.
Child Development Outcomes, measured by ASQ-Social Emotional (SE)
ASQ-SE score assessed at 18 months after birth.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Catholic Relief Services

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

Keywords

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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