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Emotional AdjustmentNCT04653441

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

A study testing Child-Caregiver-Advocacy-Resilience [ChildCARE] intervention in people with Emotional Adjustment and Aids/Hiv Problem, run by University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Emotional Adjustment, Aids/Hiv Problem
What is being tested?
Child-Caregiver-Advocacy-Resilience [ChildCARE] intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
790 participants
Where
1 siteUnited States
Study dates
15 Sep 2011to 30 Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of South Carolina

    Columbia, South Carolina, 29208

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Child-Caregiver-Advocacy-Resilience [ChildCARE] intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Child-Caregiver-Advocacy-Resilience [ChildCARE] interventionBehavioural

    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 groups in NCT04653441
Study groupRoleWhat they receive
Child-only InterventionExperimentalThe 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.
Receives: Behavioral: Child-Caregiver-Advocacy-Resilience [ChildCARE] intervention
Child+Caregiver InterventionExperimentalThe 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.
Receives: Behavioral: Child-Caregiver-Advocacy-Resilience [ChildCARE] intervention
Child+Caregiver+Community InterventionExperimentalThe 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.
Receives: Behavioral: Child-Caregiver-Advocacy-Resilience [ChildCARE] intervention
Attention ControlNo interventionChildren and caregivers who do not receive any intervention activities

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change of psychological resilience at 36 months follow up

    Resilience-related outcomes at child level

    Measured: 7 waves during 36 months with a 6-month interval

  2. change of school performance at 36 months follow up

    Children's academic performance and other schooling outcomes

    Measured: 7 waves during 36 months with a 6-month interval

  3. change of mental health status at 36 months follow up

    Children's mental health outcomes

    Measured: 7 waves during 36 months with a 6-month interval

Secondary outcomes (2)
  1. change of parenting practices at 36 months follow up

    perceptions and practices of parenting reported by both children and caregivers

    Measured: 4 waves (from caregivers) over 36 months

  2. Changes of parental depression at 36 months follow up

    Caregiver mental health outcomes

    Measured: 4 waves over 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2020
  2. Study start15 Sep 2011
  3. Primary completion30 Jul 2016
  4. Study completion30 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
790 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04653441
Sponsor's protocol ID
Pro00047860
Status last verified
Nov 2020
First submitted
6 Mar 2019
Last updated
4 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28215430

Questions about this trial

What is this clinical trial studying?

A study testing Child-Caregiver-Advocacy-Resilience [ChildCARE] intervention in people with Emotional Adjustment and Aids/Hiv Problem, run by University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change of psychological resilience at 36 months follow up (time frame: 7 waves during 36 months with a 6-month interval). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04653441, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.

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