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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Mental Disorder, Child
- 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 group | Role | What they receive |
|---|---|---|
| MISC-CBO | Experimental | 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. Receives: Behavioral: Mediational Intervention for Sensitizing Caregivers (MISC) |
| Treatment as Usual | Other | TAU 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.
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
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.
- First posted13 Jul 2023
- Study start12 Jun 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Disorder, ChildStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carla Sharp, University of Houston
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MISC-CBO: A Cluster Randomized Control Trial to Improve the Mental Health of OVC in South Africa
- ClinicalTrials.gov ID
- NCT05943132
- Acronym / sponsor ID
- STUDY00003813
- Conditions
- Mental Disorder, Child
- Keywords
- mental health problems, Mediational Intervention for Sensitizing Caregivers, mentalizing, caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 792 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 13 Jul 2023 (actual)
- 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 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| MISC-CBO | Experimental | Behavioral: Mediational Intervention for Sensitizing Caregivers (MISC)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 Usual | Other | Behavioral: Treatment as UsualTAU 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. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Status as OVC.
- Children will be 7-11 years old
- Resident in the CBO catchment area
- Child has a legal guardian
Key exclusion criteria (3 listed)
- Children with a medical history of serious birth complications
- Children with a medical history severe malnutrition
- Children with a neurological disability
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 |
|---|---|---|
| Mediational Intervention for Sensitizing Caregivers (MISC)Also: mentalization-based interventionMISC-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. | Behavioural | MISC-CBO |
| Treatment as UsualTreatment as Usual includes general support for children in homework and nutrition. | Behavioural | Treatment as Usual |
Primary outcome
Mental health problems
Time frame: Repeated measures: baseline, and again 12, 18, 24 months post baseline
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.
Quality of caregiving capacity in CBO caseworkers
Time frame: Repeated measures: baseline, and again 12 (end-of-intervention), 18 and 24 months post baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.