Clinical trial NCT04359043: MISC-CBO in Children Affected by HIV/AIDS
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Affected Children (Single and/or Double Orphans)
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: University of the Free State
name: Michigan State University
name: Bar-Ilan University, Israel
First posted: 2020-04-24
Enrollment: 104
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This was a quasi-experimental study with two treatment arms: intervention vs. TAU. Subjects were not randomized.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* orphaned (UNICEF criterion of one or both parents deceased from AIDS)
* HIV/AIDS affected child as determined by verbal autopsy measure to determine cause of death of biological parent(s)
* 7-11 year old
* resident in the CBO catchment area
* principle home caregiver of the child should be able to participate in baseline and follow-up assessments

Exclusion Criteria:

* medical history of serious birth complications
* severe malnutrition, bacterial meningitis
* encephalitis
* cerebral malaria
* known brain injury or disorder requiring hospitalization
* continued evidence of seizure or other neurological disability
* HIV infection

Primary outcomes:
measure: Change in Strengths and Difficulties Questionnaire (SDQ) Total Score as index of improvement in overall mental health in children
timeFrame: baseline, 6 months follow-up, 12 months follow-up
measure: Change in Observed Mediational Interactions (OMI; Klein, 1996) score in the caregiver's capacity to Focus the child.
timeFrame: baseline, 6 months follow-up, 12 months follow-up
measure: Change in Observed Mediational Interactions (OMI; Klein, 1996) score in the caregiver's capacity to Provide meaning to the child's subjective experience.
timeFrame: baseline, 6 months follow-up, 12 months follow-up
measure: Change in Observed Mediational Interactions (OMI; Klein, 1996) score in the caregiver's capacity to Expand the child's learning.
timeFrame: baseline, 6 months follow-up, 12 months follow-up
measure: Change in Observed Mediational Interactions (OMI; Klein, 1996) score in the caregiver's capacity to Regulate the child.
timeFrame: baseline, 6 months follow-up, 12 months follow-up
measure: Change in Observed Mediational Interactions (OMI; Klein, 1996) score in the caregiver's capacity to Reward the child.
timeFrame: baseline, 6 months follow-up, 12 months follow-up
measure: Change in Observed Mediational Interactions (OMI; Klein, 1996) score in the caregiver's capacity to utilize affective components.
timeFrame: baseline, 6 months follow-up, 12 months follow-up
measure: Change in the Kaufman Brief Intelligence Test (KBIT) overall IQ composite
timeFrame: baseline, 6 months follow-up, 12 months follow-up
measure: Change in Behavior Rating Inventory of Executive Function (BRIEF) Global Executive Composite score to assess change in executive functions as a function of the intervention.
timeFrame: baseline, 6 months follow-up, 12 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Bloemfontein
country: South Africa
facility: Community Development Support Center, UFS
state: Free State
Study officials:
References: