Cognitive and Psychosocial Benefits of MISC Training for Ugandan Children
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv
Started Sep 2008
Typical duration for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 27, 2009
CompletedFirst Posted
Study publicly available on registry
April 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedMay 15, 2009
April 1, 2009
2.6 years
April 27, 2009
May 14, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Secondary outcomes are improved caregiving as a result of year long MISC training of caregivers.
one year after commencement of MISC training
Study Arms (1)
Home visit
NO INTERVENTIONPatients will have monthly home visits during which health educational talks will be given
Interventions
Caregivers of children in the intervention arm will undergo a year long training in MISC
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Makerere Universitylead
- Michigan State Universitycollaborator
Study Sites (1)
Makerere University School of Health Sciences
Kampala, P O Box 7072, Uganda
Related Publications (3)
Ikekwere J, Ucheagwu V, Familiar-Lopez I, Sikorskii A, Awadu J, Ojuka JC, Givon D, Shohet C, Giordani B, Boivin MJ. Attention Test Improvements from a Cluster Randomized Controlled Trial of Caregiver Training for HIV-Exposed/Uninfected Ugandan Preschool Children. J Pediatr. 2021 Aug;235:226-232. doi: 10.1016/j.jpeds.2021.03.064. Epub 2021 Apr 2.
PMID: 33819464DERIVEDRuisenor-Escudero H, Familiar-Lopez I, Sikorskii A, Jambulingam N, Nakasujja N, Opoka R, Bass J, Boivin M. Nutritional and Immunological Correlates of Memory and Neurocognitive Development Among HIV-Infected Children Living in Kayunga, Uganda. J Acquir Immune Defic Syndr. 2016 Apr 15;71(5):522-9. doi: 10.1097/QAI.0000000000000905.
PMID: 26605506DERIVEDBoivin MJ, Bangirana P, Nakasujja N, Page CF, Shohet C, Givon D, Bass JK, Opoka RO, Klein PS. A year-long caregiver training program improves cognition in preschool Ugandan children with human immunodeficiency virus. J Pediatr. 2013 Nov;163(5):1409-16.e1-5. doi: 10.1016/j.jpeds.2013.06.055. Epub 2013 Aug 16.
PMID: 23958115DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Noeline Nakasujja, MD
Makerere University
- STUDY DIRECTOR
Michael Boivin, PhD
Michigan State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 27, 2009
First Posted
April 28, 2009
Study Start
September 1, 2008
Primary Completion
April 1, 2011
Study Completion
June 1, 2011
Last Updated
May 15, 2009
Record last verified: 2009-04