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Completed

NCT Number: NCT01640561

Enhancing Ugandan HIV-Affected Child Development With Caregiver Training

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.

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Key information

Conditions

HIV

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Global Health Uganda

Tororo, Uganda

About this study

Background. 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 National Institute of Mental Health (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. Intervention Method. The plan was to recruit approximately 100 Ugandan HIV-positive preschool and 200 HIV orphan caregiver/child dyads will be enlisted from Tororo District. 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 Child Behavior Checklist (CBCL). Caregiver Outcomes include an array of emotional wellbeing (EWB) and daily functioning measures validated during the initial qualitative study phase. 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 24 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. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Child age 1 through 5 years of age. If more than one child in a household qualifies, they will all be included.
  • HIV-infected or HIV-affected child who is an orphan (loss of one or both biological parents to HIV). In either case, child must have been born to a confirmed HIV-positive mother.
  • Principal caregiver of the eligible study child is able and willing to participate in a regular treatment program. The minimum agreed to participation requirement is biweekly for entire year alternating between home and office, including regular visits at 6-month intervals to the study clinic to complete lab and developmental assessments for the study child.

Exclusion criteria

  • Child illness or injury-based central nervous system (CNS) insults which are likely to overshadow the neurocognitive benefits of sensitive-period caregiver interventions.
  • Medical history of serious birth complications, severe malnutrition, bacterial meningitis, encephalitis, cerebral malaria, or other known brain injury or disorder requiring hospitalization or continued evidence of seizure or other neurological disability.
  • Current enrollment or plans for enrollment in P1 (1st grade) level of school during the first 8 months of the yearlong intervention period. Having the study child in school all day precludes necessary caregiver access to child for adequate opportunity to implement MISC training with that child. We do not expect this criterion to be problematic given that age 6 is generally the age for P1.
  • Primary caregiver cannot respond to MISC or TAU intervention because of mental illness or disability.

Treatment and study plan

MISC

Behavioral

The Mediational Interventions for Sensitizing Caregivers

UCOBAC

Behavioral

This nutrition/healthcare curriculum for children in poverty and affected by HIV was developed by a non-governmental organization (NGO) operating in Uganda called Uganda Community Based Association for Child Welfare (UCOBAC) with support from UNICEF.

Primary outcomes

  1. Change in Child Neurodevelopment post treatment

    Time frame: 12 month follow up

    Mullen Scales of Early Learning

Secondary outcomes

  1. Change in caregiver mental health and well being

    Time frame: 6-, 12-, and 24-month follow ups

    Caregiver mental health will be assessed using the Hopkins Symptom Checklist (HSCL)

  2. Midterm change in child neurodevelopment

    Time frame: 6-month follow up

    Mullen Scales of Early Learning, Early Childhood Vigilance Test (ECVT). Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P).

  3. Change in long term child neurodevelopment outcomes

    Time frame: 24-month follow ups

    Mullen Scales of Early Learning, Early Childhood Vigilance Test (ECVT). Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P).

  4. Change in child physical health and well-being

    Time frame: 6-, 12-, 24-month follow ups

    Measures of child growth (height and weight) and assessments of medical visits

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Global Health Uganda LTD
  • Michigan State University

Registry information

Acronym: MISC

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jul 13, 2012
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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