Skip to content

SMART Africa (Strengthening Mental Health Research and Training)

SMART Africa: Addressing African Youth Mental Health by Scaling Family and Community-Level EBPs

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03081195
Acronym
SMART
Enrollment
3117
Registered
2017-03-16
Start date
2017-10-06
Completion date
2021-05-31
Last updated
2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Comparison Group, Multiple Family Groups by Community Health Workers, Multiple Family Groups by Parent Peers

Keywords

child behavior, intervention, multiple family group, Sub Saharan Africa, caregivers

Brief summary

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.

Detailed 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.

Interventions

BEHAVIORALMFG

The MFG is a series of weekly meetings guided by a protocol.Over the course of 16 weeks, groups are held weekly and are facilitated by trained and supervised group leaders (in this case either parent peers or community health outreach workers). Groups can consist of up to 20 families involving adult caregivers and all children over six years of age in the family. The protocols have been designed to provide opportunities during each session to directly apply content to the realities of family life, emergent cultural and values perspectives, as well as tailor messages to age of child. Redundancy for missed appointments and opportunities for reinforcement is built in. We aim for families to attend at least 8 meetings or more (out of 16 sessions in total), as findings suggests this dose is needed to reduce child conduct problems and the majority of families reach this goal.

Sponsors

University of Ghana
CollaboratorOTHER
University of Nairobi
CollaboratorOTHER
Reach the Youth Uganda
CollaboratorOTHER
New York University
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

Schools will be randomly assigned to 3 study conditions: 1) MFG-delivered by trained family peers; 2) MFG-delivered by community health workers; or, 3) Comparison: Mental health and school support materials (books).

Eligibility

Sex/Gender
ALL
Age
8 Years to 99 Years
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Child disruptive behaviorbaseline, 8 weeks, 16 weeks, 6 monthsChange in disruptive behavior will be measured by Iowa Connors
Child impairmentbaseline, 8 weeks, 16 weeks, 6 monthsChange in disruptive behavior will be measured Impairment scale

Secondary

MeasureTime frameDescription
Sustainability8 weeks, 16 weeks, 6 monthsProgram Sustainability Assessment Tool
Implementation process8 weeks, 16 weeks, 6 monthsMetropolitan Area Child Study process measure
Parentingbaseline, 8 weeks, 16 weeks, 6 monthsChange in parenting will be measured by Alabama Parenting questionnaire
Social supportbaseline, 8 weeks, 16 weeks, 6 monthsImprovement in social support will be measured by Multidimensional scale of perceived social support -modified
Caregiver depressionbaseline, 8 weeks, 16 weeks, 6 monthsChange in caregiver depression will be measured by Center for Epidemiologic Studies Short Depression Scale
Implementation and Feasibility8 weeks, 16 weeks, 6 monthsimplementation and feasibility checklist measures
Caregiver stressbaseline, 8 weeks, 16 weeks, 6 monthsChange in caregiver stress will be measured by parent stress index short form
Child mental healthbaseline, 8 weeks, 16 weeks, 6 monthsChange in Child mental health will be measured by Strengths and Difficulties questionnaire
Child self-conceptbaseline, 8 weeks, 16 weeks, 6 monthsChange in child self-concept will be measured by tennessee self-concept
Child depressionbaseline, 8 weeks, 16 weeks, 6 monthsChange in child depression will be measured by child depression scale
Family relationsbaseline, 8 weeks, 16 weeks, 6 monthsChange in family relations will be measured by Family Relations and Cohesion scale
Caregiver mental healthbaseline, 8 weeks, 16 weeks, 6 monthsChange in caregiver mental health will be measured by Brief Symptom Checklist
Fidelityend of session at week 1, week 2, week 3, week 4, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14, week 15, week 16MFG Intervention Fidelity Assessment measures

Countries

Ghana, Kenya, Uganda, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026