HIVNCT00889395
Cognitive and Psychosocial Benefits of MISC Training for Ugandan Children
A study testing MISC training for primary caregivers in people with HIV and HIV Infections, run by Makerere University at 1 site in Uganda.
Trial 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 . Read more about this study
- Who is it for?
- Ages 16 months to 6 years
- Conditions the study is for
- HIV, HIV Infections
- What is being tested?
- MISC training for primary caregivers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUganda
- Study dates
- Sep 2008to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Makerere University School of Health Sciences
Kampala, P O Box 7072
Robert O Opoka, MD
About this study
Official title: Cognitive and Psychosocial Benefits of Caregiver Training for Ugandan HIV Children
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.
Read the 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.
- 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.
- Conditions
- HIV, HIV Infections
- Being tested
- MISC training for primary caregivers
- Keywords
- MISC, caregivers, children, psychosocial gains, cognitive benefits
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MISC training for primary caregiversBehavioural
Also called MISC group
Caregivers of children in the intervention arm will undergo a year long training in MISC
| Study group | Role | What they receive |
|---|---|---|
| Home visit | No intervention | Patients will have monthly home visits during which health educational talks will be given Receives: Behavioral: MISC training for primary caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcomes are children's cognitive and psychosocial assessment gains after year-long MISC training for their primary caregivers.
Measured: 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.
Measured: one year after commencement of MISC training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startSep 2008
- Primary completionApr 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan State University
- Investigators
- Noeline Nakasujja, MD, Principal investigator, Makerere UniversityMichael Boivin, PhD, Study director, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889395
- Sponsor's protocol ID
- 5R34MH082663-02
- Other IDs
- 5R34MH082663-02
- Status last verified
- Apr 2009
- First submitted
- 27 Apr 2009
- Last updated
- 15 May 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33819464Ruisenor-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.
PubMed 26605506Boivin 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.
PubMed 23958115
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Psychosocial Benefits of Caregiver Training for Ugandan HIV Children
- ClinicalTrials.gov ID
- NCT00889395
- Acronym / sponsor ID
- 5R34MH082663-02
- Conditions
- HIV, HIV Infections
- Keywords
- MISC, caregivers, children, psychosocial gains, cognitive benefits
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- Michigan State University
- Study start
- Sep 2008
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 28 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home visit | No intervention | Behavioral: MISC training for primary caregiversPatients will have monthly home visits during which health educational talks will be given |
Who may qualify
- Ages
- 16 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MISC training for primary caregiversAlso: MISC groupCaregivers of children in the intervention arm will undergo a year long training in MISC | Behavioural | Home visit |
Primary outcome
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
1 secondary outcome
Secondary outcomes are improved caregiving as a result of year long MISC training of caregivers.
Time frame: one year after commencement of MISC training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2009.
- Derived from this study: PubMed 33819464Ikekwere 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.
- Derived from this study: PubMed 26605506Ruisenor-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.
- Derived from this study: PubMed 23958115Boivin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noeline Nakasujja, MD principal investigator
Makerere University
Michael Boivin, PhD study director
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MISC training for primary caregivers in people with HIV and HIV Infections, run by Makerere University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert O Opoka, MD (+256772996164, opokabob@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00889395, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2009; AzTrials last refreshed its copy on 8 Nov 2026.