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

NCT04653441 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 790

Last updated 2020-12-04

No results posted yet for this 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 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.

Conditions

  • Emotional Adjustment
  • Aids/Hiv Problem

Interventions

BEHAVIORAL

Child-Caregiver-Advocacy-Resilience [ChildCARE] intervention

The proposed multimodal "Child Caregiver-Advocacy-Resilience" intervention (ChildCARE) will include three integrated components: the individual child (peer-group activities), family (caregiver parenting skill training), and the local community (community advocacy).

Sponsors & Collaborators

  • Henan University

    collaborator OTHER
  • Wayne State University

    collaborator OTHER
  • University of South Carolina

    lead OTHER

Principal Investigators

  • Xiaoming Li, PhD · University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-15
Primary Completion
2016-07-30
Completion
2017-07-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04653441 on ClinicalTrials.gov