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NCT04653441 · ClinicalTrials.gov registry record · NA
Resilience-based Psychosocial Intervention Among Children Affected by HIV/AIDS
A NA study, sponsored by University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 790
- Enrollment target
NCT04653441 is a NA study that has completed, run by University of South Carolina. The registered enrollment target is 790 participants.
The verdict
NCT04653441, a NA study, has completed, sponsored by University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 790 participants
- Enrollment target
Study Summary
Parental illness and death from HIV/AIDS has a profound and lasting impact on a child's psychosocial well-being, potentially challenging the basic needs for survival and compromising the child's future. Therefore, the impact of parental HIV/AIDS on children needs to be treated from both a public health and a developmental perspective. However, to date the role of a resilience-based approach among children affected by HIV is hypothesized but not evidence-based. In this application, we propose to develop a theory-guided, resilience-based, multimodal intervention by culturally adapting and integrating components from three SAMHSA model programs which show strong evidence in promoting protective factors among young children. The multimodal intervention will include three approach levels: the individual child (peer-group activities), the family (caregiver parenting skill training), and the local community (community advocacy). The short, medium, and long-term efficacy of the Child-Caregiver-Advocacy-Resilience \[ChildCARE\] intervention to improve health and psychosocial well-being of children will be evaluated over 36 months through a cluster randomized controlled trial. About 800 HIV/AIDS-affected children (8 to 11 years of age) and their primary caregivers will be recruited from central China where we have built a strong research infrastructure and community collaboration during our previous study. The primary outcome measures for the children will include physical health, mental health, growth and development, school performance, and a biological indicator of neurobiological stress response (salivary cortisol). The outcome measures at caregiver level will include parenting style, parental engagement, and mental health well-being. The changes at the community level will be measured using children's and caregivers' perceptions of social support and HIV-related public stigma. We will also examine the potential mechanism through which the ChildCARE intervention is exerti
Interventions
- BEHAVIORAL Child-Caregiver-Advocacy-Resilience [ChildCARE] intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 790 participants |
| Start Date | 2011-09-15 |
| Est. Completion | 2017-07-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04653441
The ClinicalTrials.gov registry entry for NCT04653441 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 790 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Carolina, which has 157 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Child-Caregiver-Advocacy-Resilience [ChildCARE] intervention is the first listed.
NCT04653441 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04653441 about?
NCT04653441 is a clinical study titled "Resilience-based Psychosocial Intervention Among Children Affected by HIV/AIDS". Parental illness and death from HIV/AIDS has a profound and lasting impact on a child's psychosocial well-being, potentially challenging the basic needs for survival and compromising the child's future. Therefore, the impact of parental HIV/AIDS on children needs to be treated from both a public hea...
What is the current status of trial NCT04653441?
This trial is currently completed. It is a NA study. The enrollment target is 790 participants. The study started on 2011-09-15. Estimated completion is 2017-07-30.
What interventions are being tested in trial NCT04653441?
The interventions under investigation include: Child-Caregiver-Advocacy-Resilience [ChildCARE] intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT04653441?
This trial is sponsored by University of South Carolina, which has 157 total clinical trials registered on ClinicalTrials.gov.
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