Cognitive and Psychosocial Benefits of MISC Training for Ugandan Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Makerere University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Michigan State University
Information provided by:
Makerere University
ClinicalTrials.gov Identifier:
NCT00889395
First received: April 27, 2009
Last updated: May 14, 2009
Last verified: April 2009
  Purpose

The Mediational Interventions for Sensitizing Caregivers (MISC) model developed by Professor Pnina Klein is to enhance the cognitive and social development of children throughout the developing world . Although MISC has proven effective in a longitudinal study in two poorer communities of Addis Ababa, Ethiopia , it has not been used with HIV households or in the Ugandan context where there is desperate need for enhanced caregiving in HIV-affected families. We propose to work with community leaders, healthcare workers, and parents/caregivers in adapting MISC to the Ugandan cultural and social context in Kayunga. For intervention families, MISC training will be added to an ongoing home health care visit (HHCV) program already in place for HIV children in Kayunga district. We will then evaluate whether MISC parent/caregiver training improves cognitive and psychosocial development in their children, and whether clinical stability of the HIV child is an important modifier for MISC training benefit.


Condition Intervention
HIV
HIV Infections
Behavioral: MISC training for primary caregivers

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Cognitive and Psychosocial Benefits of Caregiver Training for Ugandan HIV Children

Resource links provided by NLM:


Further study details as provided by Makerere University:

Primary Outcome Measures:
  • Primary outcomes are children's cognitive and psychosocial assessment gains after year-long MISC training for their primary caregivers. [ Time Frame: one year after commencement of MISC training ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcomes are improved caregiving as a result of year long MISC training of caregivers. [ Time Frame: one year after commencement of MISC training ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2008
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Home visit
Patients will have monthly home visits during which health educational talks will be given
Behavioral: MISC training for primary caregivers
Caregivers of children in the intervention arm will undergo a year long training in MISC
Other Name: MISC group

Detailed Description:

In Uganda, about 110,000 children 0 to 14 years are living with AIDS however enhanced access to ARV medications has changed the prognosis for infected children from a uniformly deadly disease early in childhood to one in which survival well into adolescence is not uncommon. However, these prognostic changes have made psychosocial, educational, and quality-of-life considerations for the HIV child all the more critical. Studies on Ugandan HIV infected children show that they have cognitive, motor and emotional problems. These findings support the need for caregiving interventions with HIV children that extend beyond provision for basic medical and nutritional care only. These findings support the urgent need for programs that minister to the emotional and psychosocial needs of HIV-affected children.

The MISC is one such intervention that has proven effective in improving the cognitive, psychosocial and emotional needs of disadvantaged children. The MISC intervention is based on the use of naturally occurring situations and objects in the home environment. The process of training the caregivers in MISC theory and strategies is structured, whereas the process of implementing MISC with the children in the household is individualized and unstructured. The training of the caregiver is focused on the acquisition of knowledge and skills necessary for effective intervention to enrich the child's home-based learning environment.

Specific Objectives.

  1. To establish the feasibility of MISC for caregivers of HIV infected children in Kayunga.
  2. To investigate whether cognition and psychosocial functioning of HIV infected children are improved by MISC.
  3. To determine whether cognitive and psychosocial gains for children of MISC-trained caregivers is moderated by disease severity of the child.

3. METHODS Phase 1: Adaptation of the MISC Study design. Adaptation of the MISC will be done using a cross sectional descriptive study. Prior to recruitment of participants, Prof. Klein will hold a series of focus group discussions (FDGs) in Kayunga to critique the MISC intervention.

Study population. Community leaders, health workers and parents/caregivers in Kayunga district, three FGDs will be held for each of these groups. They will partner with Dr. Klein in revising and adapting the MISC curriculum for training the local MISC staff who will accompany the CAI teams as they visit the HIV children and caregivers for the home health care visitation (HHCV). These CAI nursing staff will then train the caregivers each month as part of these HHCV visits.

Phase 2: MISC intervention Study design. This will be a randomized control study where HIV infected children younger than 6 yrs of age will be recruited and randomly assigned to either MISC intervention or non- intervention. All children will be recruited from the Child Health Advocacy International (CAI) project in Kayunga district during their routine home visits. Consecutive sampling will be used till the sample size is reached.

  Eligibility

Ages Eligible for Study:   16 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed HIV positive children (ELISA and Western blot), less than six years of age.

Principal caregiver(s) of the eligible study child is able and willing to attend an initial daylong training session at a central location in Kayunga, followed by home-based monthly HHCV/MISC or HHCV support/training sessions for a one-year period and accompanying caregiving, as well as clinical/medical, cognitive, and psychosocial assessments for the child.

Exclusion Criteria:

  • Medical history of serious birth complications or other known brain injury or disorder requiring hospitalization or continued evidence of seizure or other neurological disability.

Six years of age or older at start of study enrolled or planning to enroll in P1 (1st grade) level of school during the first 8 months of the year long intervention period.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889395

Contacts
Contact: Robert O Opoka, MD +256772996164 opokabob@yahoo.com
Contact: Noeline Nakasujja, MD +256772419700 drnoeline@yahoo.com

Locations
Uganda
Makerere University School of Health Sciences Recruiting
Kampala, Uganda, P O Box 7072
Principal Investigator: Robert O Opoka, MD         
Sponsors and Collaborators
Makerere University
Michigan State University
Investigators
Principal Investigator: Noeline Nakasujja, MD Makerere University
Study Director: Michael Boivin, PhD Michigan State University
  More Information

No publications provided by Makerere University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Opika Opoka, Makerere University
ClinicalTrials.gov Identifier: NCT00889395     History of Changes
Other Study ID Numbers: 5 R34 MH082663-02, 5 R34 MH082663-02
Study First Received: April 27, 2009
Last Updated: May 14, 2009
Health Authority: Uganda: Research Ethics Committee

Keywords provided by Makerere University:
MISC
caregivers
children
psychosocial gains
cognitive benefits

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 21, 2014