Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04653441
Status:
COMPLETED
Last Update Posted:
2020-12-04
First Post:
2019-03-06
Brief Title:
Resilience-based Psychosocial Intervention Among Children Affected by HIVAIDS
Sponsor:
University of South Carolina
Organization:
University of South Carolina
Study Overview
Official Title:
Resilience-based Psychosocial Intervention Among Children Affected by HIVAIDS in China
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Parental illness and death from HIVAIDS has a profound and lasting impact on a childs psychosocial well-being potentially challenging the basic needs for survival and compromising the childs future Therefore the impact of parental HIVAIDS 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 HIVAIDS-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 childrens 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 0905-0810 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 HIVAIDS 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 childrens 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 HIVAIDS 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 eg 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 HIVAIDS and other traumatic events in their lives and 3 key protective factors exist within the child and the social environment eg 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 HIVAIDS 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-based5-6Therefore 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 ie 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 eg 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 childrens primary outcomes and biological indicator salivary cortisol Hypothesis 2 The ChildCARE intervention will demonstrate short medium and long-term efficacy in improving childrens intermediate outcomes eg social-emotional competence positive future orientation and trusting relationship with current caregivers caregivers outcomes eg parenting skills mental health well-being and community-level outcomes eg childrens 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 childrens primary outcomes and biological indicator Hypothesis 4 Some contextual factors eg care arrangement household socioeconomic status SES caregivers physical health status disease progression for caregivers living with HIV will moderate the effect of ChildCARE intervention on the childrens primary outcomes and biological indicator
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-based5-6Therefore 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 ie 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 eg 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 childrens primary outcomes and biological indicator salivary cortisol Hypothesis 2 The ChildCARE intervention will demonstrate short medium and long-term efficacy in improving childrens intermediate outcomes eg social-emotional competence positive future orientation and trusting relationship with current caregivers caregivers outcomes eg parenting skills mental health well-being and community-level outcomes eg childrens 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 childrens primary outcomes and biological indicator Hypothesis 4 Some contextual factors eg care arrangement household socioeconomic status SES caregivers physical health status disease progression for caregivers living with HIV will moderate the effect of ChildCARE intervention on the childrens primary outcomes and biological indicator
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None