- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00889395
Cognitive and Psychosocial Benefits of MISC Training for Ugandan Children
Cognitive and Psychosocial Benefits of Caregiver Training for Ugandan HIV Children
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
- 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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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Kampala, Uganda, P O Box 7072
- Rekruttering
- Makerere University School of Health Sciences
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Hovedetterforsker:
- Robert O Opoka, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: Home visit
Patients will have monthly home visits during which health educational talks will be given
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Caregivers of children in the intervention arm will undergo a year long training in MISC
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Primary outcomes are children's cognitive and psychosocial assessment gains after year-long MISC training for their primary caregivers.
Tidsramme: one year after commencement of MISC training
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one year after commencement of MISC training
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Secondary outcomes are improved caregiving as a result of year long MISC training of caregivers.
Tidsramme: one year after commencement of MISC training
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one year after commencement of MISC training
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Noeline Nakasujja, MD, Makerere University
- Studieleder: Michael Boivin, PhD, Michigan State University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- Ruisenor-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.
- Boivin 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 5R34MH082663-02 (U.S. NIH-stipend/kontrakt)
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