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Mental Disorder, ChildNCT05943132

MISC-CBO to Improve the Mental Health of OVC in South Africa

A study testing Mediational Intervention for Sensitizing Caregivers (MISC) and Treatment as Usual in people with Mental Disorder, Child, run by University of Houston at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 7 to 11 yearsHealthy volunteers can take part
Conditions the study is for
Mental Disorder, Child
What is being tested?
Mediational Intervention for Sensitizing Caregivers (MISC) and Treatment as Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
792 participants
Where
1 siteSouth Africa
Study dates
12 Jun 2023to 31 Dec 2025
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 7 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Status as OVC.
  • Children will be 7-11 years old
  • Resident in the CBO catchment area
  • Child has a legal guardian

Who cannot join

  • Children with a medical history of serious birth complications
  • Children with a medical history severe malnutrition
  • Children with a neurological disability

Trial locations and contacts

1 site in 1 country.

South Africa1 site
  • University of the Free State

    Bloemfontein, Free State, 9301

Other trials in South Africa

About this study

Official title: MISC-CBO: A Cluster Randomized Control Trial to Improve the Mental Health of OVC in South Africa

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).

Read more

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.

Read the detailed description

The negative impact of acquired immunodeficiency syndrome (HIV/AIDS) on child mental health through orphanhood, parental chronic illness and poverty is well documented. These interconnecting factors led to the operational term "orphans and vulnerable children" (OVC). Currently, there are +16 million OVC, the vast majority in sub-Saharan Africa (SSA), with estimates between 1.95-3.7 million in South Africa (SA). Given the scarcity of mental health workers in SSA, community-based organizations (CBOs) offer a strategic point of intervention as an essential response to shortages in human resources for mental health. However, as yet, no Randomized Control Trial (RCT) has evaluated the effects of improving the quality of caregiving of CBO caseworkers in their daily interactions with children, conferring a missed opportunity to leverage the CBO environment directly to improve child mental health. Over the past 5 years, the investigators have successfully adapted and implemented the Mediational Intervention for Sensitizing Caregivers for CBOs building on Co-Investigator Boivin's parent-based RCTs in Uganda . MISC adapted for CBOs (MISC-CBO) is a year-long semi-structured, manualized video-feedback intervention designed to enhance the caregiving capacity of CBO caseworkers to improve child outcomes, by targeting the Research Domain Criteria systems for social processes (affiliation and attachment) in daily caseworker-child interactions. The investigators showed that MISC-CBO significantly improved caregiving quality and mental health outcomes of OVC over a 12-month period12. However, the study was a quasi-experimental feasibility trial that limits causal conclusions, did not have statistical power to detect mediating and moderating effects, did not follow up with children beyond post-intervention, and did not assess cost-effectiveness or implementation climate and readiness. Consistent with the Research Domain Criteria's dimensional approach to psychopathology, the overall goal of the proposed study is to conduct a repeated measures cluster randomized control trial to fully establish the effectiveness and trans-diagnostic mechanisms of action of MISC-CBO in high risk 7-11 year olds - a developmental stage critical for building mental health resilience against the adolescent onset of psychiatric problems. 24 CBOs will participate, each with 15 OVC and 3 caseworkers, recruited using existing NGO partner (Childline) and infrastructure in two districts in the Free State, SA, totaling 360 children (50% female; 7-11 year old, equal age bands) and 72 CBO caseworkers (100% female). The 24 CBOs will be randomly assigned to receive either one year of bi-weekly MISC-CBO or TAU. Video-based observations of caseworker caregiving quality and multi-informant child mental health will be assessed at baseline, 12 (end-of-intervention time point), 18 and 24 months. Next, the investigators will use Consolidated Framework for Implementation Research (CFIR13) constructs and input from a Community Advisory Board (CAB) to leverage the RCT to evaluate implementation costs, climate and readiness that would better position the RCT results for future uptake, scale up, and sustainability.

Aim 1. Evaluate the direct effects of MISC-CBO on child mental health. Hypotheses include that CBO caseworkers assigned to MISC-CBO vs. TAU will show continued improvement in quality of caregiving at post-intervention (12 months), 18 months, and 24 months follow-up and that children assigned to MISC-CBO vs. TAU will show continued and significant reductions in mental health symptoms at 12 months, 18 months, and 24 months follow-up.

Aim 2. Evaluate improved caregiving as mediator of follow-up outcomes (Aim 2a) and child and home characteristics as moderators of MISC-CBO vs. TAU intervention effects (Aim 2b). The investigators hypothesize that reduction in child mental health symptoms at 18 and 24 months will be mediated by improved CBO caseworker caregiving quality observed through video at post intervention (12 months), and that positive effects of MISC-CBO vs. TAU at 12, 18 and 24 months will be reduced for maternal and double orphans, and children from impoverished home environments compared to children without these risk characteristics.

Aim 3. Evaluate the cost-effectiveness of MISC-CBO for improved child mental health (Aim 3a) and evaluate implementation climate and readiness for future scale-up (Aim 3b). For Aim 3a, the investigators will follow World Health Organization (WHO) metrics to determine the cost-effectiveness of public health interventions through assessment of disability-adjusted life years (DALYs) averted. The investigators hypothesize that MISC-CBO will prove a cost-effective method to improve child mental health. For Aim 3b, the investigators will conduct three focus groups (each n=7 to total 21) with representatives from the government sector (Departments of the Free State Provincial Government), non-governmental or organized civil society (Non-Governmental Organizations and CBOs) and the University sector (Departments of Psychology and Education), at post-intervention (12 months post baseline). The investigators hypothesize that relevant community stakeholders will deem the climate favorable and ready for the implementation and scale-up of MISC-CBO, and that additional barriers and facilitators for scale-up and implementation will be identified.

Study impact. The proposed work will test the real-world effectiveness, mechanisms of action, cost-effectiveness and implementation readiness of a culturally sensitive, community-based mental health intervention, MISC-CBO, during the critical developmental window of at-risk children aging into adolescence. The program of research is therefore in line with the third strategic objective of the National Institute of Mental Health ("Strive for prevention and cure") that articulates the need for validated targets for interventions, and improved methods to match interventions to under-served individuals and populations that can be scaled for greater public health impact.

Being tested
Mediational Intervention for Sensitizing Caregivers (MISC), Treatment as Usual
Keywords
mental health problems, Mediational Intervention for Sensitizing Caregivers, mentalizing, caregivers
Medical subject headings
Neurodevelopmental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mediational Intervention for Sensitizing Caregivers (MISC)Behavioural

    Also called mentalization-based intervention

    MISC-CBO is a year-long semi-structured, manualized video-feedback caregiver intervention that targets key components in caregiver-child interactions known to improve caregiving quality and child outcomes. These components include emotional and cognitive components shown to improve socio-emotional and cognitive developmental outcomes in children.

  • Treatment as UsualBehavioural

    Treatment as Usual includes general support for children in homework and nutrition.

Study groups in NCT05943132
Study groupRoleWhat they receive
MISC-CBOExperimentalMISC-CBO is a year-long semi-structured, manualized video-feedback caregiver intervention that targets key components in caregiver-child interactions known to improve caregiving quality and child outcomes. These components include emotional and cognitive components shown to improve socio-emotional and cognitive developmental outcomes in children.
Receives: Behavioral: Mediational Intervention for Sensitizing Caregivers (MISC)
Treatment as UsualOtherTAU at CBOs include provision of meals, counselling services mostly focused on social support, financial assistance, and healthcare counseling - all which promote the mental health of OVC, but does not include a specific focus on caregiving quality.
Receives: Behavioral: Treatment as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mental health problems

    Reduced mental health problems in children will be assessed by the Strengths and Difficulties Questionnaire (SDQ). The is a multi-informant 25-item measure of emotional and behavioral disorders for children aged 3-17 widely used across the world. Both informant and youth versions of the SDQ utilize a three-point Likert scale ranging from 'not true (0)', 'somewhat true' (1), to 'certainly true' (2). The use of a total difficulties score is common as a general index of mental health problems. Scores may range from 0 to 60 with higher scores indicating increased mental health problems.

    Measured: Repeated measures: baseline, and again 12, 18, 24 months post baseline

  2. Quality of caregiving capacity in CBO caseworkers

    Improved quality caregiving is measured by a standardized MISC videotaped observational tool, the Observing Mediational Interaction (OMI). The OMI is an observational tool that counts the number of times caregivers engage in behaviors that promote cognitive and social development in children. As such, it has a minimum range of 0; however it has no upper range as any number of behaviors may be coded during an interaction. Increased frequency of sensitive behaviors indicates increased quality of caregiving.

    Measured: Repeated measures: baseline, and again 12 (end-of-intervention), 18 and 24 months post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2023
  2. Study start12 Jun 2023
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
24 Community-based Organizations (CBOs) (360 children), their caregivers at home and 72 CBO caseworkers are enrolled. Randomization takes place at the level of the CBO so that half of the CBOs receive MISC and the other half receives TAU.
Masking
None (open label)
Enrolment
792 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05943132
Sponsor's protocol ID
STUDY00003813
Status last verified
Aug 2026
First submitted
22 Jun 2023
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Mediational Intervention for Sensitizing Caregivers (MISC) and Treatment as Usual in people with Mental Disorder, Child, run by University of Houston at 1 site in South Africa.

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 4 inclusion and 3 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: finished, as of the sponsor's last update on 31 Aug 2026. 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 South Africa. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mental health problems (time frame: Repeated measures: baseline, and again 12, 18, 24 months post baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 31 Aug 2026.

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