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

Primary Purpose

Emotional Adjustment, Aids/Hiv Problem

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Child-Caregiver-Advocacy-Resilience [ChildCARE] intervention
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emotional Adjustment

Eligibility Criteria

8 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 8 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)

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Child-only Intervention

Child+Caregiver Intervention

Child+Caregiver+Community Intervention

Attention Control

Arm Description

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.

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.

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.

Children and caregivers who do not receive any intervention activities

Outcomes

Primary Outcome Measures

change of psychological resilience at 36 months follow up
Resilience-related outcomes at child level
change of school performance at 36 months follow up
Children's academic performance and other schooling outcomes
change of mental health status at 36 months follow up
Children's mental health outcomes

Secondary Outcome Measures

change of parenting practices at 36 months follow up
perceptions and practices of parenting reported by both children and caregivers
Changes of parental depression at 36 months follow up
Caregiver mental health outcomes

Full Information

First Posted
March 6, 2019
Last Updated
November 28, 2020
Sponsor
University of South Carolina
Collaborators
Henan University, Wayne State University
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1. Study Identification

Unique Protocol Identification Number
NCT04653441
Brief Title
Resilience-based Psychosocial Intervention Among Children Affected by HIV/AIDS
Official Title
Resilience-based Psychosocial Intervention Among Children Affected by HIV/AIDS in China
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 15, 2011 (Actual)
Primary Completion Date
July 30, 2016 (Actual)
Study Completion Date
July 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
Collaborators
Henan University, Wayne State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
During the past five years (09/05-08/10) we were funded by R01MH76488 to study the psychosocial needs of children affected by HIV including both orphans (children under 18 who lost one or both of their parents to HIV/AIDS) and vulnerable children (children with one or both parents infected with HIV) in rural China. The overarching goal of our previous study was to inform the development of effective, culturally appropriate, and sustainable psychosocial interventions for these children. Guided by a developmental psychopathology perspective, we constructed an assessment model that integrated research findings from the literatures on bereavement, attachment, risk and resilience to delineate the children's psychosocial needs following HIV-related parental death or illness1. We incorporated both individual and environmental factors that potentially could moderate or mediate the negative effects of parental HIV/AIDS on these children. The comprehensive qualitative and quantitative data we collected and reported in 29 peer-reviewed publications during the past five years have provided the critical foundation for a cultural adaptation of theory-driven psychosocial prevention programs among children affected by HIV. The main findings from this body of research included 1) children affected by HIV experienced greater mental and developmental challenges (e.g., trauma symptoms, depression, social isolation, poor school performance) than comparison children who were from the same community but did not experience HIV-related illness and death in their families; 2) some children demonstrated tremendous resilience reflected in good school performances and the absence of elevated levels of psychosocial problems despite parental HIV/AIDS and other traumatic events in their lives; and, 3) key protective factors exist within the child and the social environment (e.g., positive future orientation, trusted caregivers, and supportive community) which could contribute to resilience in these children, and hence buffer the children from the detrimental effects of parental HIV/AIDS. The proposed project will examine whether the protective factors identified in our previous study are amenable to intervention and whether their hypothesized changes can indeed explain improvement in mental and developmental outcomes among participating children. From research on early childhood development, compelling evidence has revealed the critical importance of successful adaptation in the face of adversity ("resilience") for laying the foundation for successful adjustment later in life2-4. However, to date the utility of a resilience-based intervention approach among children affected by HIV is hypothesized but not evidence-based5-6.Therefore, in this application, we propose to adapt three evidence-based programs to produce a theory-driven resilience-based intervention to improve the well-being of children affected by HIV in rural China. 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). The short, medium, and long-term efficacy of the ChildCARe intervention will be evaluated over 36 months through a cluster randomized controlled trial (RCT). 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 (i.e., salivary cortisol). There are three specific aims and four hypotheses in our application: AIM #1: Develop a theory-guided, resilience-based, multimodal intervention [ChildCARe] by culturally adapting and integrating components from three SAMHSA model programs which show strong evidence in promoting protective factors among children; the adaptation process will be informed by 1) the data collected from our previous study; 2) our 18 years' experience in developing and adapting effective HIV behavioral prevention programs in various cultural settings including China; and 3) input from the local collaborators and communities (e.g., community advisory board and research participants); AIM #2: Test the efficacy of the ChildCARe intervention through a cluster RCT involving 800 HIV-affected children (8 to 11 years of age) and their primary caregivers from 80 villages in central China where we have built a strong research infrastructure and community collaboration during our previous study; AIM #3: Examine the potential mechanism of the intervention by identifying improvement in protective factors and other individual and contextual factors that potentially mediate or moderate the intervention effect; Hypothesis #1: The ChildCARe intervention will demonstrate short, medium, and long-term efficacy in improving children's primary outcomes and biological indicator (salivary cortisol); Hypothesis #2: The ChildCARE intervention will demonstrate short, medium, and long-term efficacy in improving children's intermediate outcomes (e.g., social-emotional competence, positive future orientation, and trusting relationship with current caregivers), caregiver's outcomes (e.g., parenting skills, mental health well-being), and community-level outcomes (e.g., children's and caregivers' perceptions of social support); Hypothesis #3: Improvement in intermediate outcomes at levels of child, family, and community will mediate the effect of the ChildCARE intervention on the children's primary outcomes and biological indicator; Hypothesis #4: Some contextual factors (e.g., care arrangement, household socioeconomic status [SES], caregiver's physical health status, disease progression for caregivers living with HIV) will moderate the effect of ChildCARE intervention on the children's primary outcomes and biological indicator.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Adjustment, Aids/Hiv Problem

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
790 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Child-only Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Child+Caregiver Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Child+Caregiver+Community Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Control
Arm Type
No Intervention
Arm Description
Children and caregivers who do not receive any intervention activities
Intervention Type
Behavioral
Intervention Name(s)
Child-Caregiver-Advocacy-Resilience [ChildCARE] intervention
Intervention Description
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).
Primary Outcome Measure Information:
Title
change of psychological resilience at 36 months follow up
Description
Resilience-related outcomes at child level
Time Frame
7 waves during 36 months with a 6-month interval
Title
change of school performance at 36 months follow up
Description
Children's academic performance and other schooling outcomes
Time Frame
7 waves during 36 months with a 6-month interval
Title
change of mental health status at 36 months follow up
Description
Children's mental health outcomes
Time Frame
7 waves during 36 months with a 6-month interval
Secondary Outcome Measure Information:
Title
change of parenting practices at 36 months follow up
Description
perceptions and practices of parenting reported by both children and caregivers
Time Frame
4 waves (from caregivers) over 36 months
Title
Changes of parental depression at 36 months follow up
Description
Caregiver mental health outcomes
Time Frame
4 waves over 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 8 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) Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoming Li, PhD
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28215430
Citation
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.
Results Reference
result

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

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