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Enhancing Ugandan HIV-Affected Child Development With Caregiver Training (MISC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Johns Hopkins Bloomberg School of Public Health.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Michigan State University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Judith Bass, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01640561
First received: July 10, 2012
Last updated: July 11, 2012
Last verified: July 2012
History of Changes
  Purpose
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.

Condition Intervention
HIV
 Behavioral: MISC
Behavioral: UCOBAC

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Ugandan HIV-Affected Child Development With Caregiver Training

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Change in Child Neurodevelopment post treatment [ Time Frame: 12 month follow up ] [ Designated as safety issue: No ]
    Mullen Scales of Early Learning


Secondary Outcome Measures:
  • Change in caregiver mental health and well being [ Time Frame: 6-, 12-, 18-, and 24-month follow ups ] [ Designated as safety issue: No ]
    Caregiver mental health will be assessed using the Hopkins Symptom Checklist (HSCL)

  • Midterm change in child neurodevelopment [ Time Frame: 6-month follow up ] [ Designated as safety issue: No ]
    Mullen Scales of Early Learning, Early Childhood Vigilance Test (ECVT). Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P).

  • Change in long term child neurodevelopment outcomes [ Time Frame: 18-month and 24-month follow ups ] [ Designated as safety issue: No ]
    Mullen Scales of Early Learning, Early Childhood Vigilance Test (ECVT). Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P).

  • Change in child physical health and well-being [ Time Frame: 6-, 12-, 18-, and 24-month follow ups ] [ Designated as safety issue: No ]
    Measures of child growth (height and weight) and assessments of medical visits
Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MISC
The Mediational Interventions for Sensitizing Caregivers (MISC) model developed by Professor Pnina Klein (consultant) has been used to enhance the development of children throughout the developing world, with the support of such international aid agencies as WHO, UNICEF, NORAD, and Redd Barna (Norway).
 Behavioral: MISC
The Mediational Interventions for Sensitizing Caregivers
Active Comparator: Enhanced Treatment as Usual Behavioral: UCOBAC
This nutrition/healthcare curriculum for children in poverty and affected by HIV was developed by an NGO operating in Uganda called UCOBAC (Uganda Community Based Association for Child Welfare) with support from UNICEF.

Detailed Description:
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 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. 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. 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. 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
  Eligibility
Ages Eligible for Study:   1 Year to 5 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01640561

Contacts
Contact: Michael Boivin Michael.Boivin@hc.msu.edu

Locations
Uganda
Global Health Uganda Recruiting
Tororo, Uganda
Contact: Roland Namwanja    0782 746 500    namroland@yahoo.com   
Sub-Investigator: Noeline Nakasujja         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Michigan State University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Michael Boivin, PhD Michigan State University
Principal Investigator: Judy Bass, PhD Johns Hopkins Bloomberg School of Public Health
  More Information

Responsible Party: Judith Bass, Assistant Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01640561     History of Changes
Other Study ID Numbers: JHU-MSU-UGANDA-2012  R01HD070723-01 
Study First Received: July 10, 2012
Last Updated: July 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
HIV affected
Child Neurodevelopment
Low and Middle Income Country

ClinicalTrials.gov processed this record on September 23, 2016