SMART Africa (Strengthening Mental Health Research and Training) (SMART)

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

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.

Study Overview

• Status: Completed
• Conditions: Comparison Group; Multiple Family Groups by Parent Peers; Multiple Family Groups by Community Health Workers
• Intervention / Treatment: Behavioral: MFG

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.

• Study Type: Interventional
• Enrollment (Actual): 3117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ghana
  • Accra, Ghana
    • University of Ghana
• Kenya
  • Nairobi, Kenya
    • University of Nairobi
• Uganda
  • Masaka, Uganda
    • Reach the Youth Uganda
• United States
  • Missouri
    • St. Louis, Missouri, United States, 63130
      • Washington University in St. Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MFG-delivered by trained family peers; 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	Behavioral: MFG; 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.; Other Names: 4Rs and 2Ss; Amaka Amasanyufu (Happy Families in Luganda-Uganda); Dang-Malgu (Family Togetherness in Dagbani-Ghana)
Experimental: MFG-delivered by CHWs; 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	Behavioral: MFG; 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.; Other Names: 4Rs and 2Ss; Amaka Amasanyufu (Happy Families in Luganda-Uganda); Dang-Malgu (Family Togetherness in Dagbani-Ghana)
No Intervention: Bolstered care; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child disruptive behavior	Change in disruptive behavior will be measured by Iowa Connors	baseline, 8 weeks, 16 weeks, 6 months
Child impairment	Change in disruptive behavior will be measured Impairment scale	baseline, 8 weeks, 16 weeks, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation and Feasibility	implementation and feasibility checklist measures	8 weeks, 16 weeks, 6 months
Fidelity	MFG Intervention Fidelity Assessment measures	end 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 16
Sustainability	Program Sustainability Assessment Tool	8 weeks, 16 weeks, 6 months
Implementation process	Metropolitan Area Child Study process measure	8 weeks, 16 weeks, 6 months
Parenting	Change in parenting will be measured by Alabama Parenting questionnaire	baseline, 8 weeks, 16 weeks, 6 months
Social support	Improvement in social support will be measured by Multidimensional scale of perceived social support -modified	baseline, 8 weeks, 16 weeks, 6 months
Caregiver depression	Change in caregiver depression will be measured by Center for Epidemiologic Studies Short Depression Scale	baseline, 8 weeks, 16 weeks, 6 months
Caregiver mental health	Change in caregiver mental health will be measured by Brief Symptom Checklist	baseline, 8 weeks, 16 weeks, 6 months
Caregiver stress	Change in caregiver stress will be measured by parent stress index short form	baseline, 8 weeks, 16 weeks, 6 months
Child mental health	Change in Child mental health will be measured by Strengths and Difficulties questionnaire	baseline, 8 weeks, 16 weeks, 6 months
Child self-concept	Change in child self-concept will be measured by tennessee self-concept	baseline, 8 weeks, 16 weeks, 6 months
Child depression	Change in child depression will be measured by child depression scale	baseline, 8 weeks, 16 weeks, 6 months
Family relations	Change in family relations will be measured by Family Relations and Cohesion scale	baseline, 8 weeks, 16 weeks, 6 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Institute of Mental Health (NIMH); New York University; University of Nairobi; University of Ghana; Reach the Youth Uganda
• Investigators: Principal Investigator: Fred Ssewamala, PhD, Washington University School of Medicine; Principal Investigator: Mary McKay, PhD, Washington University School of Medicine

Publications and helpful links

General Publications

• Brathwaite R, Ssewamala FM, Sensoy Bahar O, McKay MM, Neilands TB, Namatovu P, Kiyingi J, Zmachinski L, Nabayinda J, Huang KY, Kivumbi A, Bhana A, Mwebembezi A, Petersen I, Hoagwood K; SMART Africa - Uganda Field Team. The longitudinal impact of an evidence-based multiple family group intervention (Amaka Amasanyufu) on oppositional defiant disorder and impaired functioning among children in Uganda: analysis of a cluster randomized trial from the SMART Africa-Uganda scale-up study (2016-2022). J Child Psychol Psychiatry. 2022 Nov;63(11):1252-1260. doi: 10.1111/jcpp.13566. Epub 2022 Jan 6.
• Asampong E, Ibrahim A, Sensoy-Bahar O, Kumbelim K, Yaro PB, McKay MM, Ssewamala FM. Adaptation and Implementation of the Multiple-Family Group Intervention in Ghana. Psychiatr Serv. 2021 May 1;72(5):571-577. doi: 10.1176/appi.ps.201900626. Epub 2021 Jan 12.
• Ssewamala FM, Sensoy Bahar O, McKay MM, Hoagwood K, Huang KY, Pringle B. Strengthening mental health and research training in Sub-Saharan Africa (SMART Africa): Uganda study protocol. Trials. 2018 Aug 6;19(1):423. doi: 10.1186/s13063-018-2751-z.

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2017
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: February 23, 2017
• First Submitted That Met QC Criteria: March 15, 2017
• First Posted (Actual): March 16, 2017

Study Record Updates

• Last Update Posted (Actual): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: child behavior; intervention; caregivers; multiple family group; Sub Saharan Africa
• Other Study ID Numbers: U19MH110001-011; U19MH110001 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There will be no individual participant data that will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No