Early Childhood Development in HIV-Exposed ChildrenNCT03195036
Evaluation of an Early Childhood Development Intervention for HIV-Exposed Children in Cameroon
A study testing Home-based ECD services in people with Early Childhood Development in HIV-Exposed Children, run by Duke University at 1 site in Cameroon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Childhood Development in HIV-Exposed Children
- What is being tested?
- Home-based ECD services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteCameroon
- Study dates
- 17 Apr 2017to 30 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Home-based ECD services
- Keywords
- HIV-exposed, Early Childhood Development, Cameroon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based ECD servicesBehavioural
Also called KIDSS Project Home-Based Visits
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group of women/children dyads who consent and are patients at the control clinics will not have any exposure to ECD programming. |
| Intervention Arm | Experimental | 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. Receives: Behavioral: Home-based ECD services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attainment of age-appropriate developmental milestones
Child Development Outcomes, measured by ASQ-3 (18-month survey)
Measured: ASQ-3 score assessed 18 months after birth.
Attainment of age-appropriate developmental milestones
Child Development Outcomes, measured by ASQ-3 (12-month survey)
Measured: ASQ-3 score assessed 12 months after birth.
Attainment of age-appropriate developmental milestones
Child Development Outcomes, measured by ASQ-3 (6-month survey)
Measured: ASQ-3 score assessed 6 months after birth.
Secondary outcomes (1)
Attainment of age-appropriate developmental milestones
Child Development Outcomes, measured by ASQ-Social Emotional (SE)
Measured: ASQ-SE score assessed at 18 months after birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start17 Apr 2017
- Primary completion30 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood Development in HIV-Exposed ChildrenStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic Relief Services
- Responsible party
- Principal investigator, Joy Noel Baumgartner, Duke University
- Investigators
- Joy N Baumgartner, PhD, MSSW, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195036
- Sponsor's protocol ID
- D0989
- Other IDs
- 2017/02/867/CE/CNERSH/SP
- Status last verified
- Oct 2019
- First submitted
- 16 Jun 2017
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Early Childhood Development Intervention for HIV-Exposed Children in Cameroon
- ClinicalTrials.gov ID
- NCT03195036
- Acronym / sponsor ID
- D0989
- Keywords
- HIV-exposed, Early Childhood Development, Cameroon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Catholic Relief Services
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group of women/children dyads who consent and are patients at the control clinics will not have any exposure to ECD programming. |
| Intervention Arm | Experimental | Behavioral: Home-based ECD servicesThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based ECD servicesAlso: KIDSS Project Home-Based VisitsHealth 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. | Behavioural | Intervention Arm |
Primary outcome
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)
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)
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)
1 secondary outcome
Attainment of age-appropriate developmental milestones
Time frame: ASQ-SE score assessed at 18 months after birth.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joy N Baumgartner, PhD, MSSW principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based ECD services in people with Early Childhood Development in HIV-Exposed Children, run by Duke University at 1 site in Cameroon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cameroon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attainment of age-appropriate developmental milestones (time frame: ASQ-3 score assessed 18 months after birth.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019; AzTrials last refreshed its copy on 6 Nov 2026.