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

NCT05943132 | Recruiting DMC

• 1 other identifier: STUDY00003813
• Study Type: interventional
• Target: 792
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mental Disorder, Child

Keywords

mental health problems; Mediational Intervention for Sensitizing Caregivers; mentalizing; caregivers

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Study Arms (2)

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.

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.

Behavioral: Treatment as Usual

Interventions

Mediational Intervention for Sensitizing Caregivers (MISC) BEHAVIORAL

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.

Also known as: mentalization-based intervention

MISC-CBO

Treatment as Usual BEHAVIORAL

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

Treatment as Usual

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Houston: lead

Study Sites (1)

University of the Free State

Bloemfontein, Free State, 9301, South Africa

RECRUITING

MeSH Terms

Conditions

Neurodevelopmental Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Carla Sharp, Ph.D.

CONTACT

7137438612; csharp2@uh.edu

Bree Cervantes, BA

CONTACT

9497422939; brcervan@CougarNet.UH.EDU

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Developmental Psychopathology Lab Clinical Psychology

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 13, 2023
• Study Start: June 12, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

ZA (1)