MISC-CBO in Children Affected by HIV/AIDS
Condition: HIV Affected Children (Single and/or Double Orphans)
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

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.
    

Intervention name(s): Mediational Intervention for Sensitizing Caregivers (MISC); Treatment as Usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): MISC is an intervention that focuses on increasing the caregiving capacity of the caregiver by enhancing a set of emotional and cognitive components that collectively, sensitizes the caregiver to the emotional and cognitive needs of the child.; Treatment as Usual was delivered by community-based organization caseworkers. It consists of a nutritional curriculum of the same dosage and time commitment as the experimental condition, but with no caregiving component.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a quasi-experimental study with two treatment arms: intervention vs. TAU. Subjects were not randomized.
Masking: None (Open Label)
Primary purpose: Prevention