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Cognitive and Psychosocial Benefits of MISC Training for Ugandan Children

Primary Purpose

HIV, HIV Infections

Status
Unknown status
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
MISC training for primary caregivers
Sponsored by
Makerere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV focused on measuring MISC, caregivers, children, psychosocial gains, cognitive benefits

Eligibility Criteria

16 Months - 6 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Makerere University School of Health SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Home visit

Arm Description

Patients will have monthly home visits during which health educational talks will be given

Outcomes

Primary Outcome Measures

Primary outcomes are children's cognitive and psychosocial assessment gains after year-long MISC training for their primary caregivers.

Secondary Outcome Measures

Secondary outcomes are improved caregiving as a result of year long MISC training of caregivers.

Full Information

First Posted
April 27, 2009
Last Updated
May 14, 2009
Sponsor
Makerere University
Collaborators
Michigan State University
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1. Study Identification

Unique Protocol Identification Number
NCT00889395
Brief Title
Cognitive and Psychosocial Benefits of MISC Training for Ugandan Children
Official Title
Cognitive and Psychosocial Benefits of Caregiver Training for Ugandan HIV Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Makerere University
Collaborators
Michigan State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, HIV Infections
Keywords
MISC, caregivers, children, psychosocial gains, cognitive benefits

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home visit
Arm Type
No Intervention
Arm Description
Patients will have monthly home visits during which health educational talks will be given
Intervention Type
Behavioral
Intervention Name(s)
MISC training for primary caregivers
Other Intervention Name(s)
MISC group
Intervention Description
Caregivers of children in the intervention arm will undergo a year long training in MISC
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Secondary outcomes are improved caregiving as a result of year long MISC training of caregivers.
Time Frame
one year after commencement of MISC training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert O Opoka, MD
Phone
+256772996164
Email
opokabob@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Noeline Nakasujja, MD
Phone
+256772419700
Email
drnoeline@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noeline Nakasujja, MD
Organizational Affiliation
Makerere University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Boivin, PhD
Organizational Affiliation
Michigan State University
Official's Role
Study Director
Facility Information:
Facility Name
Makerere University School of Health Sciences
City
Kampala
ZIP/Postal Code
P O Box 7072
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert O Opoka, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
33819464
Citation
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.
Results Reference
derived
PubMed Identifier
26605506
Citation
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.
Results Reference
derived
PubMed Identifier
23958115
Citation
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.
Results Reference
derived

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Cognitive and Psychosocial Benefits of MISC Training for Ugandan Children

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