MISC-CBO to Improve the Mental Health of OVC in South Africa
Recruiting
N/AInterventional Study
Mental Disorder, Child
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
7 – 11
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
792 (estimated)
Sponsor
University of Houston · Other
Who this trial is looking for
This trial is looking for children aged 7 to 11 who are orphans or vulnerable and live in the Free State area of South Africa. Participants will receive a special intervention designed to improve their mental health over 24 months.
Are You a Good Fit for This Trial?
You may be able to join if
I am an orphan or vulnerable child.
I am 7 to 11 years old.
I live in the catchment area of the community-based organization.
I have a legal guardian.
You may not be able to join if
I have a medical history of serious birth complications.
I have a medical history of severe malnutrition.
I have a neurological disability.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The goal of this cluster randomized control clinical trial is to evaluate the effectiveness of the Mediational Intervention for Sensitizing Caregivers for Community-based Organizations (MISC-CBO) in reducing mental health problems in orphan and vulnerable children in South Africa.
Aim 1 will evaluate the direct effects of MISC-CBO on video-coded CBO caseworker caregiving quality (affiliation and …
The goal of this cluster randomized control clinical trial is to evaluate the effectiveness of the Mediational Intervention for Sensitizing Caregivers for Community-based Organizations (MISC-CBO) in reducing mental health problems in orphan and vulnerable children in South Africa.
Aim 1 will evaluate the direct effects of MISC-CBO on video-coded CBO caseworker caregiving quality (affiliation and attachment) and children's mental health outcomes over a 24 month period. 24 CBOs (360 children and 72 caseworkers) will be recruited using existing Non-Governmental Organization (NGO) partner (Childline) in two districts in the Free State, South Africa (SA). CBOs will be randomly assigned to receive either one year of bi-weekly MISC-CBO or Treatment as Usual (TAU). The investigators hypothesize that MISC-CBO will be associated with comparative increases in caseworker caregiving quality and reductions in mental health problems in Orphans and Vulnerable Children (OVC).
Aim 2a,will test the hypothesis that caregiving quality at end-of-intervention (12 months) accounts for intervention effects on child mental health at 18 and 24 months. Aim 2b will evaluate the moderating effects of orphan status and the quality of the home environment, expecting that OVC who are maternal and double orphans, and from impoverished home environments will show reduced response to intervention compared to children without these risk factors.
Aim 3a will use World Health Organization metrics to test the hypothesis that MISC-CBO is cost-effective in terms of disability-adjusted life years (DALYs) averted. Aim 3b will use qualitative methodology to test the hypothesis that community stakeholders deem the climate favorable and ready for the implementation of MISC-CBO, and that additional barriers and facilitators for scale-up and implementation will be identified.
The proposed work extends the investigators' formative work to now fully test the real-world effectiveness, mechanisms of action, cost-effectiveness and implementation readiness of MISC-CBO during the critical developmental window of at-risk children aging into adolescence, consistent with National Institute of Mental Health's strategic objectives.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Status as OVC.
2. Children will be 7-11 years old
3. Resident in the CBO catchment area
4. Child has a legal guardian
Exclusion Criteria:
1. Children with a medical history of serious birth complications
2. Children with a medical history severe malnutrition
3. Children wit…
Inclusion Criteria:
1. Status as OVC.
2. Children will be 7-11 years old
3. Resident in the CBO catchment area
4. Child has a legal guardian
Exclusion Criteria:
1. Children with a medical history of serious birth complications
2. Children with a medical history severe malnutrition
3. Children with a neurological disability
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