Enhancing Ugandan HIV-Affected Child Development With Caregiver Training (MISC)
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ClinicalTrials.gov Identifier: NCT01640561 |
Recruitment Status
: Unknown
Verified July 2012 by Judith Bass, Johns Hopkins Bloomberg School of Public Health.
Recruitment status was: Recruiting
First Posted
: July 13, 2012
Last Update Posted
: July 13, 2012
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Condition or disease | Intervention/treatment | Phase |
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HIV | Behavioral: MISC Behavioral: UCOBAC | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Enhancing Ugandan HIV-Affected Child Development With Caregiver Training |
Study Start Date : | January 2012 |
Estimated Primary Completion Date : | December 2015 |
Estimated Study Completion Date : | December 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: MISC
The Mediational Interventions for Sensitizing Caregivers (MISC) model developed by Professor Pnina Klein (consultant) has been used to enhance the development of children throughout the developing world, with the support of such international aid agencies as WHO, UNICEF, NORAD, and Redd Barna (Norway).
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Behavioral: MISC
The Mediational Interventions for Sensitizing Caregivers
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Active Comparator: Enhanced Treatment as Usual |
Behavioral: UCOBAC
This nutrition/healthcare curriculum for children in poverty and affected by HIV was developed by an NGO operating in Uganda called UCOBAC (Uganda Community Based Association for Child Welfare) with support from UNICEF.
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- Change in Child Neurodevelopment post treatment [ Time Frame: 12 month follow up ]Mullen Scales of Early Learning
- Change in caregiver mental health and well being [ Time Frame: 6-, 12-, 18-, and 24-month follow ups ]Caregiver mental health will be assessed using the Hopkins Symptom Checklist (HSCL)
- Midterm change in child neurodevelopment [ Time Frame: 6-month follow up ]Mullen Scales of Early Learning, Early Childhood Vigilance Test (ECVT). Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P).
- Change in long term child neurodevelopment outcomes [ Time Frame: 18-month and 24-month follow ups ]Mullen Scales of Early Learning, Early Childhood Vigilance Test (ECVT). Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P).
- Change in child physical health and well-being [ Time Frame: 6-, 12-, 18-, and 24-month follow ups ]Measures of child growth (height and weight) and assessments of medical visits

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Ages Eligible for Study: | 1 Year to 5 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Child age 1 through 5 years of age. If more than one child in a household qualifies, they will all be included.
- HIV-infected or HIV-affected child who is an orphan (loss of one or both biological parents to HIV). In either case, child must have been born to a confirmed HIV-positive mother.
- Principal caregiver of the eligible study child is able and willing to participate in a regular treatment program. The minimum agreed to participation requirement is biweekly for entire year alternating between home and office, including regular visits at 6-month intervals to the study clinic to complete lab and developmental assessments for the study child.
Exclusion Criteria:
- Child illness or injury-based CNS insults which are likely to overshadow the neurocognitive benefits of sensitive-period caregiver interventions.
- Medical history of serious birth complications, severe malnutrition, bacterial meningitis, encephalitis, cerebral malaria, or other known brain injury or disorder requiring hospitalization or continued evidence of seizure or other neurological disability.
- Current enrollment or plans for enrollment in P1 (1st grade) level of school during the first 8 months of the yearlong intervention period. Having the study child in school all day precludes necessary caregiver access to child for adequate opportunity to implement MISC training with that child. We do not expect this criterion to be problematic given that age 6 is generally the age for P1.
- Primary caregiver cannot respond to MISC or TAU intervention because of mental illness or disability.

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): NCT01640561
Contact: Michael Boivin | Michael.Boivin@hc.msu.edu |
Uganda | |
Global Health Uganda | Recruiting |
Tororo, Uganda | |
Contact: Roland Namwanja 0782 746 500 namroland@yahoo.com | |
Sub-Investigator: Noeline Nakasujja |
Principal Investigator: | Michael Boivin, PhD | Michigan State University | |
Principal Investigator: | Judy Bass, PhD | Johns Hopkins Bloomberg School of Public Health |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Judith Bass, Assistant Professor, Johns Hopkins Bloomberg School of Public Health |
ClinicalTrials.gov Identifier: | NCT01640561 History of Changes |
Other Study ID Numbers: |
JHU-MSU-UGANDA-2012 R01HD070723-01 ( U.S. NIH Grant/Contract ) |
First Posted: | July 13, 2012 Key Record Dates |
Last Update Posted: | July 13, 2012 |
Last Verified: | July 2012 |
Keywords provided by Judith Bass, Johns Hopkins Bloomberg School of Public Health:
HIV affected Child Neurodevelopment Low and Middle Income Country |