SMART Africa (Strengthening Mental Health Research and Training)

The Washington University

Status: Completed

Conditions: Comparison Group; Multiple Family Groups by Parent Peers; Multiple Family Groups by Community Health Workers

Treatments: Behavioral: MFG

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03081195

U19MH110001 (U.S. NIH Grant/Contract)

U19MH110001-011

Details and patient eligibility

About

The objective of this research study is to examine the implementation of and outcomes associated with an evidence-based practice (EBP), specifically Multiple Family Group (MFG) targeting youth disruptive behavior challenges and success, through a scale up intervention study in Uganda, and two pilot studies that will be conducted in Kenya and Ghana.

Full description

A longitudinal experimental mixed methods effectiveness-implementation hybrid research design will be employed. The study will be conducted across thirty primary schools representing both semi-urban and rural communities. We expect to involve 3,000 youth (in primary schools grades 2 through 7; 8 to 13 years) and their adult caregivers (3,000) in Uganda, 180 youth and their caregivers (180) in Ghana, and 180 youth and their caregivers (180) in Kenya.

Schools will be randomly assigned to 3 study conditions: 1) MFG-delivered by trained family peers; 2) MFG-delivered by community health workers (school health education program coordinators in Ghana); or, 3) Comparison: mental health and school support materials (e.g., books, uniforms). Data will be collected at baseline, 8 and 16 weeks, and 6 months follow-up (10 months from baseline).

More specifically the objectives of this study are:

Primary objectives

1. To examine short- and long-term outcomes associated with the MFG. Hypothesis: Children in the treatment groups (MFG) will improve significantly more compared to those in the comparison (usual care) group.

2. To examine how systematic variations in the delivery of an evidence-based MFG program impacts outcomes for children with behavioral difficulties and their caregivers in each country context.

   Hypothesis: Children who participate in MFG with their families will display significantly reduced conduct difficulties and increased functioning over time compared to those involved in comparison condition. We expect that parent peers - compared to community health workers - will evidence significantly more success engaging families to attend MFG sessions, thus, children in the MFG-parent peer delivered condition will evidence the great improvement relative to the other two study conditions.

   Secondary objectives

3. To compare the uptake and implementation of MFGs by trained existing family peers and community outreach health workers.

   Hypothesis: Given the level of training that community outreach health workers have received prior to the study as part of their regular professional training, they will evidence higher fidelity initially, yet with training and ongoing supervision, we expect these differences to decrease over time.

4. To examine multi-level (state/government, NGOs, families, schools, communities) influences on the uptake, implementation, effectiveness and sustainability of EBPs that address serious child disruptive behavioral challenges.

Enrollment: 3,117 patients

Sex: All

Ages: 8 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inclusion criteria for caregiver/child dyads:

• Adult caregiver of a child in primary school, grades two through 7, ages 8 to 13 years

• Adult caregiver willing to consent and available for research and intervention activities

• Child between the ages 8 to 13 or in primary school (grades two through seven) who is screened for ODD or CD as measured by the Disruptive Behavior Disorder Rating Scale, Impairment Scale, and Iowa Conners Scale.

• Child willing to assent.

  • Inclusion criteria for parent peers:

• Caregivers of children who agree to be trained to provide support to families.

  • Inclusion criteria for community health workers

• Lay paraprofessionals who work within primary care settings.

  • Inclusion criteria for school directors

• Directors who oversee schools where the proposed intervention will have been tested.

Exclusion criteria

• Exclusion criteria for caregiver/child dyads:

• Lack of understanding of study and study procedures as determined by the research team

• Child or caregiver refusal to participate

  • Exclusion criteria for parent peers:

• Refusal to participate

  • Exclusion criteria for community health workers

• Refusal to participate

  • Exclusion criteria for school directors

• Refusal to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,117 participants in 3 patient groups

MFG-delivered by trained family peers

Experimental group

Description:

MFG delivered by trained parent peers drawn from local school planning councils: 10 schools; 60 parent peers (6 per school x 10); 1,000 children and adult caregivers; children screened to evidence serious emerging and clinically significant DBDs

Treatment:

Behavioral: MFG

MFG-delivered by CHWs

Experimental group

Description:

MFG delivered by community health workers (CHW) drawn from local primary care clinics: 10 schools; 60 community health workers (6 assigned to children per school x 10); 1,000 children and adult caregivers; children screened to evidence serious emerging and clinically significant DBDs

Treatment:

Behavioral: MFG

Bolstered care

No Intervention group

Description:

Comparison (Bolstered care): Mental health wellness materials and educational supports (e.g. books, uniforms) 10 schools; 1,000 children and adult caregivers; children screened to evidence serious emerging and clinically significant DBDs