Cognitive and Psychosocial Benefits of MISC Training for Ugandan Children
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|ClinicalTrials.gov Identifier: NCT00889395|
Recruitment Status : Unknown
Verified April 2009 by Makerere University.
Recruitment status was: Recruiting
First Posted : April 28, 2009
Last Update Posted : May 15, 2009
|Condition or disease||Intervention/treatment|
|HIV HIV Infections||Behavioral: MISC training for primary caregivers|
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.
- To establish the feasibility of MISC for caregivers of HIV infected children in Kayunga.
- To investigate whether cognition and psychosocial functioning of HIV infected children are improved by MISC.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Cognitive and Psychosocial Benefits of Caregiver Training for Ugandan HIV Children|
|Study Start Date :||September 2008|
|Estimated Primary Completion Date :||April 2011|
|Estimated Study Completion Date :||June 2011|
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
- 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 ]
- Secondary outcomes are improved caregiving as a result of year long MISC training of caregivers. [ Time Frame: one year after commencement of MISC training ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00889395
|Contact: Robert O Opoka, MDemail@example.com|
|Contact: Noeline Nakasujja, MDfirstname.lastname@example.org|
|Makerere University School of Health Sciences||Recruiting|
|Kampala, Uganda, P O Box 7072|
|Principal Investigator: Robert O Opoka, MD|
|Principal Investigator:||Noeline Nakasujja, MD||Makerere University|
|Study Director:||Michael Boivin, PhD||Michigan State University|