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Evaluation of an Early Childhood Development Intervention for HIV-Exposed Children in Cameroon

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ClinicalTrials.gov Identifier: NCT03195036
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : October 14, 2019
Sponsor:
Collaborator:
Catholic Relief Services
Information provided by (Responsible Party):
Joy Noel Baumgartner, Duke University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Early Childhood Development in HIV-Exposed Children Behavioral: Home-based ECD services Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study utilizes a cluster-randomized trial (CRT) design in order to evaluate the impact of the KIDSS ECD program delivered by Catholic Relief Services, specifically the home visiting component, on child development outcomes and utilization of HIV testing services. 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 health facility (cluster) level due to issues of program feasibility.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of an Early Childhood Development Intervention for HIV-Exposed Children in Cameroon
Actual Study Start Date : April 17, 2017
Actual Primary Completion Date : July 30, 2019
Actual Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine


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 Name: KIDSS Project Home-Based Visits




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03195036


Locations
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Cameroon
Catholic Relief Services
Yaoundé, Cameroon
Sponsors and Collaborators
Duke University
Catholic Relief Services
Investigators
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Principal Investigator: Joy N Baumgartner, PhD, MSSW Duke University

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Responsible Party: Joy Noel Baumgartner, Assistant Research Professor; Director, Evidence Lab, Duke University
ClinicalTrials.gov Identifier: NCT03195036     History of Changes
Other Study ID Numbers: D0989
2017/02/867/CE/CNERSH/SP ( Other Identifier: Comite National d'Ethique de la Recherche pour la Sante Hum. )
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 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 Joy Noel Baumgartner, Duke University:
HIV-exposed
Early Childhood Development
Cameroon