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Completed Not applicable Interventional Accepts healthy volunteers

Resilience-based Psychosocial Intervention Among Children Affected by HIV/AIDS

ClinicalTrials.gov ID: NCT04653441

Public ClinicalTrials.gov record NCT04653441. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

Resilience-based Psychosocial Intervention Among Children Affected by HIV/AIDS in China

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 exerting its impact by identifying improvement in protective factors and other individual and contextual factors that potentially mediate or moderate the intervention effect. This proposed project will examine whether the multilevel protective factors we identified in our initial project are amenable to intervention and whether their hypothesized changes explain improvement in children outcomes.

Study identification

NCT ID
NCT04653441
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Enrollment
790 participants

Conditions and interventions

Eligibility (public fields only)

Age range
8 Years to 17 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 14, 2011
Primary completion
Jul 29, 2016
Completion
Jul 29, 2017
Last update posted
Dec 3, 2020

2011 – 2017

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of South Carolina Columbia South Carolina 29208

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04653441, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 3, 2020 · Synced Sep 6, 2026

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