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

NCT04653441 | Completed

• 1 other identifier: Pro00047860
• Study Type: interventional
• Target: 790
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• change of psychological resilience at 36 months follow up

  Resilience-related outcomes at child level

  7 waves during 36 months with a 6-month interval

• change of school performance at 36 months follow up

  Children's academic performance and other schooling outcomes

  7 waves during 36 months with a 6-month interval

• change of mental health status at 36 months follow up

  Children's mental health outcomes

  7 waves during 36 months with a 6-month interval

Secondary Outcomes (2)

• change of parenting practices at 36 months follow up

  4 waves (from caregivers) over 36 months

• Changes of parental depression at 36 months follow up

  4 waves over 36 months

Study Arms (4)

Child-only Intervention

EXPERIMENTAL

The children in this arm will receive only child intervention curriculum (peer group activities). The child intervention includes 20 hours of facilitator-guided programming delivered in 10 sessions in a peer-group setting and aims to increase resilience by developing a number of skills including positive thinking, emotional regulation, coping, and problem solving.

Behavioral: Child-Caregiver-Advocacy-Resilience [ChildCARE] intervention

Child+Caregiver Intervention

EXPERIMENTAL

The children in this arm will receive child intervention and their caregivers will receive the caregiver intervention, At the caregiver level, caregivers receive 10 hours of facilitator-guided programming delivered in five sessions that aims to increase positive parenting skills and build the capacity of the caregiver to engage in self-care and seek support.

Behavioral: Child-Caregiver-Advocacy-Resilience [ChildCARE] intervention

Child+Caregiver+Community Intervention

EXPERIMENTAL

The children in this arm will received child intervention; their family will receive caregiver intervention and community-based intervention. At the community level, trained community advocates (e.g., teachers, village nurses) conduct monthly home visits and organize a series of community-based activities over a period of two years to promote cohesion and strength within local communities and to increase community support for affected families.

Behavioral: Child-Caregiver-Advocacy-Resilience [ChildCARE] intervention

Attention Control

NO INTERVENTION

Children and caregivers who do not receive any intervention activities

Interventions

Child-Caregiver-Advocacy-Resilience [ChildCARE] intervention BEHAVIORAL

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).

Child+Caregiver Intervention; Child+Caregiver+Community Intervention; Child-only Intervention

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• to 17 years of age
• having lost one or both parent to AIDS (orphans) or are currently living with a HIV-positive parent (vulnerable children)

You may not qualify if:

• children living in centralized care setting;
• known HIV-infection;
• physical illness and developmental disability (e.g., severe mental retardation) that prevent them from engaging routine daily activities;
• plan to permanently relocate outside of the province within a year.

Sponsors & Collaborators

• University of South Carolina: lead
• Henan University: collaborator
• Wayne State University: collaborator

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Publications (1)

• Li X, Harrison SE, Fairchild AJ, Chi P, Zhao J, Zhao G. A randomized controlled trial of a resilience-based intervention on psychosocial well-being of children affected by HIV/AIDS: Effects at 6- and 12-month follow-up. Soc Sci Med. 2017 Oct;190:256-264. doi: 10.1016/j.socscimed.2017.02.007. Epub 2017 Feb 13.

  PMID: 28215430 RESULT

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Xiaoming Li, PhD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Endowed Chair

Model Details: 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).

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: December 4, 2020
• Study Start: September 15, 2011
• Primary Completion: July 30, 2016
• Study Completion: July 30, 2017
• Last Updated: December 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)