MISC-CBO in Children Affected by HIV/AIDS

University of Houston

Status: Completed

Conditions: HIV Affected Children (Single and/or Double Orphans)

Treatments: Behavioral: Treatment as Usual; Behavioral: Mediational Intervention for Sensitizing Caregivers (MISC)

Study type: Interventional

Funder types: Other

Identifiers

NCT04359043

15598-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 7 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Mediational Intervention for Sensitizing Caregivers

Experimental group

Description:

Half of the child participants and the careworkers in the Community-based Organization taking care of them, received the Mediational Intervention for Sensitizing Caregivers.

Treatment:

Behavioral: Mediational Intervention for Sensitizing Caregivers (MISC)

Treatment as Usual

Other group

Description:

The other half of child participants and the careworkers in the Community-based Organization taking care of them, received Treatment as Usual which consists of the usual services delivered to children at the CBO: food, help with homework, registrations for birth certificates.

Treatment:

Behavioral: Treatment as Usual