Cognitive and Psychosocial Benefits of MISC Training for Ugandan Children

HIV Infections Clinical Trial

Official title:

Cognitive and Psychosocial Benefits of Caregiver Training for Ugandan HIV Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00889395
• Other study ID #: 5R34MH082663-02
• Secondary ID: 5R34MH082663-02
• Status: Recruiting
• Phase: N/A
• First received: April 27, 2009
• Last updated: May 14, 2009
• Start date: September 2008
• Est. completion date: June 2011

Study information

• Verified date: April 2009
• Source: Makerere University
• Contact: Robert O Opoka, MD
• Phone: +256772996164
• Email: opokabob[@]yahoo.com
• Is FDA regulated: No
• Health authority: Uganda: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Months to 6 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• HIV
• HIV Infections

Intervention

Behavioral:
• MISC training for primary caregivers
Caregivers of children in the intervention arm will undergo a year long training in MISC

Locations

Country	Name	City	State
Uganda	Makerere University School of Health Sciences	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
Makerere University	Michigan State University

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcomes are children's cognitive and psychosocial assessment gains after year-long MISC training for their primary caregivers.		one year after commencement of MISC training	No
Secondary	Secondary outcomes are improved caregiving as a result of year long MISC training of caregivers.		one year after commencement of MISC training	No