HIV Affected Children (Single and/or Double Orphans) Clinical Trial
Official title:
The Acceptability and Feasibility of an Adaptation of The Mediational Intervention for Sensitizing Caregivers for Community Based Organizations in a Sample of South African HIV/AIDS Orphans
Currently, 12 million children in Sub-Saharan Africa and 1.9 million children in South Africa (SA) are orphaned by HIV/AIDS. Research addressing what can be done to support these children has been limited, clustered and of variable quality. Our prior work showed that an important support structure for care of HIV affected children (orphans) in SA is through Community Based Organizations (CBOs). Currently, no evidence-based CBO intervention exist. CBO careworkers report low efficacy in addressing the mental health and cognitive developmental needs of children. There is therefore a critical need to empower frontline CBO careworkers to be trained in addressing the mental health and cognitive developmental needs of orphans. The Mediational Intervention for Sensitizing Caregivers (MISC) used in our previous work with parents in Uganda holds promise. The objective in this application is to use a mixed methods approach (observations, focus groups, questionnaires) to test the acceptability and feasibility of adapting MISC to be used by CBO careworkers instead of parents (MISC-CBO), and to assess preliminary outcomes. Guided by the Mathews and Hudson's framework for evaluating caregiver-child training programs, our approach will consist of three phases: Adapt, Process evaluation, Outcome evaluation. In Phase 1 (Adapt, Year 1) we will conduct formative research (qualitative interviews and focus groups) with community stakeholders, a Community Advisory Board and children to ascertain feasibility and acceptability of MISC-CBO in the SA cultural context with 7-11 year old AIDS orphans. In Phase 2 (Implementation and process evaluation, Year 2) we will recruit 80 AIDS orphans through 4 CBOs (20 children and 4 careworkers from each CBO). Two CBOs will be allocated to MISC-CBO and 2 will be allocated to treatment as usual (TAU of comparable contact hours). One year of bi-weekly (every 2 weeks) intervention sessions will be conducted. Process evaluation will include individual interviews, observations, focus groups and questionnaire-based assessment of MISC-CBO feasibility, adherence and fidelity. In Phase 3 (Outcomes assessment, Years 2 & 3) the effects of MISC-CBO to promote mental health and cognitive development through the mechanism of improved quality of caregiving by CBO careworkers will be assessed through mental health and cognitive assessments at baseline (beginning of Year 2), 6, 12 and 18 months compared to TAU in the children and careworkers recruited in Phase 2. At the end of this formative RO1 that transforms a parent intervention into a CBO careworker intervention, we will have established the foundational assessments and intervention to apply for an RO1 to evaluate a randomized controlled trial designed to fully test the efficacy of MISC-CBO during the critical developmental window of at-risk HIV affected children aging into adolescence. This project will make possible the only culture-appropriate and sustainable evidence-based CBO intervention that can be readily and effectively implemented globally in low-resource settings with children generally at risk from disease, malnutrition and neglect.
Currently, 12 million children in Sub-Saharan Africa and 1.9 million children in South Africa
(SA) are orphaned by HIV/AIDS1. Research addressing what can be done to support these
children has been limited, clustered and of variable quality2. Our prior work in SA (PI:
Sharp; R01 MH078757) showed that an important care support structure for orphans is through
Community Based Organizations (CBOs). Currently, no evidence-based CBO interventions exist.
Moreover, CBO careworkers report a desire to learn how to address the mental health and
cognitive developmental needs of children3. There is a critical need to empower frontline CBO
careworkers to be trained in how to respond to the mental health and cognitive developmental
needs of orphans. The Mediational Intervention for Sensitizing Caregivers (MISC)4-6 used in
our previous work (PI: Boivin; R34 MH082663; RO1 HD070723) with parents in Uganda holds
promise. The objective of this application is to use a mixed methods approach to test the
acceptability and feasibility of adapting MISC for CBOs (MISC-CBO), and to assess preliminary
outcomes. Guided by the Mathews and Hudson's framework for evaluating caregiver-child
training programs7, our approach will consist of three phases: Adapt, Process Evaluation,
Outcome Evaluation. Our central hypothesis is that feasibility and acceptability of MISC-CBO
will be established and that positive preliminary outcomes will be demonstrated.
Aim 1: Adapt MISC to establish acceptability of MISC-CBO (Yr 1). We will conduct formative
research (qualitative interviews and focus groups) with community stakeholders, a Community
Advisory Board (CAB) and children to ascertain feasibility and acceptability of MISC-CBO with
7-11 year olds affected by HIV/AIDS in SA. Hyp1: Formative work will result in an adaptation
of MISC that is deemed acceptable.
Aim 2: Implementation and process evaluation of MISC-CBO to establish feasibility, adherence
and fidelity (Yr 2). We will recruit N = 80 HIV/AIDS orphans through 4 CBOs (i.e. 20
children, 4 careworkers and CBO director from each CBO). Two CBOs will be allocated to
MISC-CBO while the other 2 will be allocated to treatment as usual (TAU of comparable contact
hours). After initial training, one year of bi-weekly (every 2 weeks) intervention sessions
of MISC-CBO and TAU will be conducted. Process evaluation will include individual interviews,
observations, focus groups and questionnaire-based assessment of feasibility of the
intervention perceived by CBO careworkers, directors and children themselves. MISC-CBO
adherence and fidelity will be assessed. Hyp2: CBO careworkers and directors will readily and
reliably participate in bi-weekly MISC-CBO training and evaluation. Hyp3: Qualitative
interviews will show that CBO careworkers and directors support the goals and affordability
of MISC-CBO. Hyp4: Video footage and questionnaire data will show fidelity to MISC-CBO in
terms of content and caregiving adherence.
Aim 3: Outcomes evaluation of MISC-CBO (Yrs 2 & 3). The effects of MISC-CBO on mental health
and cognitive development through the mechanism of improved quality of CBO caregiving will be
assessed through assessments at baseline (the beginning of Yr 2), 6, 12 and 18 months
compared to TAU in the children and careworkers recruited in Aim 2. Hyp5: MISC-CBO
careworkers will have significantly more positive interactions with study children compared
with TAU careworkers. Hyp6: Children in MISC-CBO will show reduction in symptoms of emotional
and behavior problems and increased behaviors indicative of positive emotional outcomes as
determined by observations and questionnaire data. Hyp7: Children in MISC-CBO's cognitive
ability tests scores will improve. Hyp8: The cognitive and mental health gains for children
will be statistically mediated by improved caregiving quality and increased knowledge of MISC
principles in MISC-CBO workers.
Overall impact. This is a small-scale, developmental 3-year RO1 that builds on our
established US-SA-NIH partnerships (Sharp, Marais, Skinner, Serekoane) to develop an expanded
research team (adding MISC experts Boivin and Klein), and create a CAB to assist in the
adaptation of MISC for CBOs. Our proposed research is in line with the NIH priorities as well
as UNICEF's goal of strengthening the capacities of communities, and fits with our long-term
research goal to address the mental health needs of HIV/AIDS affected children. At the end of
this formative study, we will have established the foundational assessments and intervention
to apply for an RO1 to evaluate a randomized controlled trial designed to fully test the
efficacy of MISC-CBO during the critical developmental window of at-risk HIV affected
children aging into adolescence. This project will make possible the only culture-appropriate
and sustainable evidence-based CBO intervention that can be readily and effectively
implemented globally in low-resource settings with children generally at risk from disease,
malnutrition and neglect.
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