Cognitive and Psychosocial Benefits of MISC Training for Ugandan Children
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 27, 2009 | ||||||||
| Last Updated Date | May 14, 2009 | ||||||||
| Start Date ICMJE | September 2008 | ||||||||
| Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00889395 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Cognitive and Psychosocial Benefits of MISC Training for Ugandan Children | ||||||||
| Official Title ICMJE | Cognitive and Psychosocial Benefits of Caregiver Training for Ugandan HIV Children | ||||||||
| Brief 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. |
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| 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.
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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) | No Intervention: Home visit
Patients will have monthly home visits during which health educational talks will be given
Intervention: Behavioral: MISC training for primary caregivers |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 120 | ||||||||
| Estimated Completion Date | June 2011 | ||||||||
| Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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:
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. |
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| Gender | Both | ||||||||
| Ages | 16 Months to 6 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Uganda | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00889395 | ||||||||
| Other Study ID Numbers ICMJE | 5 R34 MH082663-02, 5 R34 MH082663-02 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Robert Opika Opoka, Makerere University | ||||||||
| Study Sponsor ICMJE | Makerere University | ||||||||
| Collaborators ICMJE | Michigan State University | ||||||||
| Investigators ICMJE |
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| Information Provided By | Makerere University | ||||||||
| Verification Date | April 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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