Study Title: A family-based economic empowerment model for orphaned children in Uganda
Study Aims: The overall goal of this R34 is to further develop and examine a family economic empowerment intervention, called SUUBI-MAKA, that creates economic opportunities for families in Uganda who are caring for children orphaned due to the AIDS pandemic, and to lay the groundwork for an R01. The study has two specific aims: (1) To conduct formative work in order to understand children and families’ ability and interest in participating in a family-level economic empowerment intervention focused on savings and family income generation, and their response to this family-focused economic empowerment approach alongside additional intervention components, including savings for youth education and adult mentorship. (2) Based on formative data (Aim #1), to adapt the intervention and examine issues related to feasibility and preliminary outcome on a small scale in order to prepare for a larger study. The intervention, SUUBI-MAKA, uses a novel approach by focusing on economic empowerment of families caring for children orphaned due to AIDS. The intervention has three key components: (1) it promotes family-level income generating projects (micro-enterprises) which we believe will enhance economic stability, reduce poverty, and enhance protective family processes for youth orphaned by AIDS. (2) It promotes monetary savings for educational opportunities for AIDS-orphaned children. (3) It provides an adult mentor to children.
Methods: The intervention will be evaluated via a two-group randomized trial. The two groups are: SUUBI-MAKA or Usual care for orphaned children. The participating children will be nested within 20 primary schools that will be randomly assigned such that all children from a particular school receive the same intervention. There will be three assessment points: baseline (pre-test), 12-month, and 24-month post-intervention. The effectiveness of SUUBI-MAKA will be compared with the Usual care on: children’ educational experience, psychosocial development, sexual risk taking, and mental health, caregiver’s attitudes and capacities, and family and caregiving relationships.
Principal Investigator: Fred Ssewamala (Columbia University)
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Study Title: Neuropsychological benefits of cognitive training in Ugandan HIV children
Context: Over 110,000 HIV Ugandan children are at risk for neurocognitive disorders due to the progressive encephalopathy of CNS HIV infection. Even if clinically stable, these children can have motor, attention, memory, visual-spatial processing, and other executive function impairment.
Study Aims: Study Aim 1: To compare the neuropsychological benefit of 24 training sessions of Captain’s Log CCRT to the active and passive control groups over a 8-week period, and at 3-month follow-up. Study Aim 2: To compare the psychiatric benefit of 24 training sessions of Captain’s Log CCRT to the active and passive control groups over an 8-week period, and at 3-month follow-up. Study Aim 3: To evaluate how HIV subtype, ART treatment status, and the corresponding clinical stability of the child modifies CCRT neuropsychological performance gains and psychiatric symptom reduction.
Methods: One-hundred and fifty school-age children with HIV in Kayunga District, Uganda, will serve as our participants. Fifty of these children will be randomly selected to receive 24 training sessions of a computerized cognitive rehabilitation therapy (CCRT) program called Captain’s Log, marketed mostly for American children with attention or learning problems. A locked version of Captain’s Log which does not direct the child’s training in a progressive manner will be administered to a second “active control” group; while a third group will be a passive control group not receiving any computer training intervention. Outcome Assessments: The Kaufman Assessment Battery for Children, 2nd ed. (KABC-2), Tests of Variables of Attention (TOVA) visual and auditory tests, CogState computerized neuropsychological screening test, Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), and Achenbach Child Behavior Checklist (CBCL) will be administered before and after the 8-week training period and at 3-month follow-up. We have previously used all these assessments with Ugandan children with HIV to effectively evaluate neuropsychological and psychiatric problems. Captain’s Log has an internal evaluator feature which will help us monitor the specific training tasks to which the children best respond. Based on our prior research with Kayunga children with HIV, we anticipate that about 40% of our sample will be on ART at study enrollment, and about 20% will be Subtype D while 60% will be subtype A. We also observed that children with HIV Subtype A are at greater risk for neurocognitive deficits. Analyses: We will compare neuropsychological and psychiatric gains over the 8-week training period and at 3-mo follow-up for our three study groups, anticipating that they will be significantly greater for the CCRT intervention children (Study Aims 1 & 2). These neuropsychological gains will be associated with improved school performance over the long-term. Intervention children on ART will have greater gains than those not on ART, and HIV subtype D children will have lower viral loads and higher lymphocyte activation levels, resulting in greater gains from CCRT (Study Aim 3). Conclusion: CCRT will prove effective and sustainable in potentiating the neurocognitive benefit of ART in HIV children. It will prove viable for assessing and treating children in resource-poor settings.
Public Health Relevance: Beyond the direct neurodevelopmental impact of pediatric HIV infection, the public health burden of HIV disease for tens of millions of HIV children and orphans globally is monumental when considering how it further compromises quality of home environment and educational opportunity for children already impoverished. If computerized cognitive training proves practical and effective for enhancing neuropsychological function and psychiatric well-being in HIV children, then this would support the second of the UN Millennium Development Goals, which is to ensure that all children have the best opportunity to complete primary schooling. Computerized cognitive training and assessment might also allow for cost/effective interventions in resource poor settings in low-income countries, where special education or medical rehabilitative care by trained professionals are not available.
Principal Investigator: Michael J. Boivin (Michigan State University)
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Study Title: Enhancing Ugandan HIV-Affected child development with caregiver training
Context: Children up to the age of 5 years affected by HIV are the most vulnerable subgroup of HIV populations globally, especially in low-resource areas. This is because of the strategic, volatile, and vulnerable nature of this highly sensitive period of child development. Mediational intervention for sensitizing caregivers (MISC) has a structured training program to enable caregivers to improve their children’s cognitive and social development during everyday casual interactions in the home.In our preliminary NIMH R34 findings, Ugandan HIV children of caregivers receiving MISC training biweekly for a year showed significantly greater gains on the Mullen Early Learning Scales Composite of g fluid intelligence, when compared to children whose caregivers received a standard health/nutrition education intervention (treatment as usual or TAU). The MISC caregivers were also significantly less depressed, and their child mortality that year was significantly lower.
Study Aims: Study Aim 1 will evaluate if MISC significantly enhances child outcomes when compared to controls for both HIV-positive and orphan children when assessed from baseline to 6, 12, and 18 months. Study Aim 2 will evaluate if MISC significantly enhances caregiver EWB and daily functioning outcomes. To better understand the mechanisms of MISC-enhanced child development, a Secondary Aim is to evaluate the mediating effect of improved caregiver EWB outcomes on corresponding child development gains, and the modifying effects of caregiver HIV illness and functioning on child outcomes.
Methods: One hundred Ugandan HIV-positive preschool and 200 HIV orphan caregiver/child dyads will be enlisted from Kayunga and Pallisa Districts. These dyads will be randomly assigned by village clusters to either biweekly MISC or health/nutrition education TAU intervention for one year. Child Outcomes are the child development gains on the Mullen, the Early Childhood Vigilance Test (ECVT) of attention, and the Color- Object Association Test (COAT) of memory, the Behavior Rating Inventory of Executive Functioning – Preschool (BRIEF-P), and the caregiver administered version of the Achenbach CBCL. Caregiver Outcomes include an array of emotional wellbeing (EWB) and daily functioning measures validated during the initial qualitative study phase.
Implications: The Overall Impact comes from establishing the feasibility, acceptability, and effectiveness of MISC for HIV orphans and vulnerable children (OVC) and their caregivers in low resource settings; the sustainability of MISC in low resource settings since it is not dependent on published materials or outside resources; the complementary dual impact of significant psychotherapeutic benefit for the caregiver, especially mothers struggling with HIV disease. MISC will also reduce HIV child mortality because in our initial R34 findings, MISC heightened maternal bonding, sensitivity to serious illness, and the prompter seeking of medical care. It also can improve treatment adherence. Finally, our evidence-based MISC caregiver training interventions can be readily implemented globally as a sustainable way to augment OVC cognitive, psychosocial, and medical wellbeing.
Public Health Relevance: Early childhood (up to age 5 yrs) is a period of dramatic change in the cognitive, emotional, social, and behavioral domains; children continuously progress by observing and interacting with the world around them. In the face of economic instability and nutritional, medical and educational deprivation, HIV-affected very young children are the most vulnerable HIV subgroup globally because their families are often the most vulnerable, with little margin for sustaining a favorable developmental milieu for the child. Through strategic caregiver interventions during this sensitive period of child neurodevelopment, our study findings have the potential for positively re-directing the developmental trajectories of tens of millions of HIV-affected children globally.
Principal Investigator: Michael J. Boivin (Michigan State University)
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Study Title: Cognitive and Psychosocial Benefit of caregiver training for Ugandan HIV children
Context: 110,000 Ugandan HIV children and 1 million non-infected AIDS orphans will have poor or inconsistent caregiving because one or both parents are ill or dead from AIDS (UNAIDS 2006). Consequently, the cognitive and social development of these children may be stunted in early childhood, and eventually they will perform more poorly in school. Mediational intervention for sensitizing caregivers (MISC) has a structured curriculum and training program to teach HIV mothers/caregivers the skills for enhancing their child’s cognitive and social development in the home each day. This is done by teaching mothers/caregivers how to focus a child’s attention, excite a child’s interest, expand her cognitive awareness, encourage her sense of competence, and regulate behavior during play, feeding, bathing and working.
Study Aims: To adapt MISC to the Ugandan context and demonstrate its effectiveness for enhancing the cognitive and social development of HIV children and orphans, we will use a four-part protocol for evaluating parent training programs: context evaluation, input evaluation, process evaluation, and product evaluation (CIPP Model of Evaluation). Study Aim 1 is the context evaluation of MISC through the use of focus groups of local community leaders, teachers, and caregivers, partnering with us to adapt MISC to the Ugandan context. Study Aim 2 involves the input evaluation of appropriateness and acceptability of MISC training for the caregivers and household through interviews and training compliance. Study Aim 3 is the process evaluation of the fidelity of intervention though home observation and evaluation of HOME quality, and videotape evaluation of caregiving interactions between mother/caregiver and child, as well as changes in the caregivers own attitudes and approach throughout the year-long training period. Study Aim 4 evaluates the product or benefit of the MISC training; in terms of the child’s gains on the Mullen Scales of Early Learning, the Early Childhood Vigilance Test (ECVT) of attention, the Color-Object Association Test (COAT) for memory, and the Child Behavior Checklist (CBCL) for psychosocial adjustment.
Methods: Mothers/caregivers of half of 120 HIV-infected and 120 non-infected preschool AIDS orphans in Kayunga District, Uganda, will be assigned to monthly home-based MISC training for one year. The remaining children and caregivers will continue to receive the regular monthly home health care visits. MISC for both the HIV infected and non-infected orphans will lead to greater gains on the Mullen learning, ECVT attention, and COAT memory scores compared to non- intervention children. These gains will be mediated by improved scores on monthly videotaped caregiving samples evaluated for MISC features, HOME scale quality of home environment, and child/caregiver quality interactions (CCQI) scores from home-based observations. These gains will be moderated by clinical stability of the HIV children.
Implications: Establishing the feasibility and effectiveness of MISC caregiving training will provide a strategic and sustainable means of cognitive enhancement for millions of HIV-affected children in resource-poor settings. Beyond the direct neurodevelopmental impact of pediatric HIV infection, the public health burden of HIV disease for tens of millions of HIV orphans globally is monumental when considering how it further compromises quality of home environment and caregiving for children already impoverished. In the African context, home-based caregiver training interventions to enhance the developmental milieu of HIV-affected children may be the single most developmentally strategic, culturally relevant, and resource sustainable means of buffering them from this impact of HIV disease. More broadly, caregiver training interventions may also enhance the cognitive ability and psychosocial adjustment of all children at risk from poverty and other public health challenges to the second of the UN Millennium Development Goals, which is to ensure that all children are able to complete primary schooling.
Principal Investigator: Michael Joseph Boivin (Michigan State University)
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