SMART Africa (Strengthening Mental Health Research and Training)

NCT03081195 | Completed DMC

• 2 other identifiers: U19MH110001-011U19MH110001
• Study Type: interventional
• Target: 3,117
• Locations: 4 countries
• Sites: 4

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Implementation and Feasibility

  8 weeks, 16 weeks, 6 months

• Fidelity

  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

  8 weeks, 16 weeks, 6 months

• Implementation process

  8 weeks, 16 weeks, 6 months

• Parenting

  baseline, 8 weeks, 16 weeks, 6 months

Study Arms (3)

MFG-delivered by trained family peers

EXPERIMENTAL

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

MFG-delivered by CHWs

EXPERIMENTAL

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

Bolstered care

NO INTERVENTION

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

Interventions

MFG BEHAVIORAL

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.

Also known as: 4Rs and 2Ss, Amaka Amasanyufu (Happy Families in Luganda-Uganda), Dang-Malgu (Family Togetherness in Dagbani-Ghana)

MFG-delivered by CHWs; MFG-delivered by trained family peers

Eligibility Criteria

• Age: 8 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Caregivers of children who agree to be trained to provide support to families.
• Lay paraprofessionals who work within primary care settings.
• Directors who oversee schools where the proposed intervention will have been tested.

You may not qualify if:

• Lack of understanding of study and study procedures as determined by the research team
• Child or caregiver refusal to participate
• Refusal to participate
• Refusal to participate
• Refusal to participate

Sponsors & Collaborators

• Washington University School of Medicine: lead
• University of Ghana: collaborator
• University of Nairobi: collaborator
• Reach the Youth Uganda: collaborator
• New York University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (4)

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

University of Ghana

Accra, Ghana

Location

University of Nairobi

Nairobi, Kenya

Location

Reach the Youth Uganda

Masaka, Uganda

Location

Related Publications (5)

• Ssewamala FM, Brathwaite R, Sensoy Bahar O, Namatovu P, Neilands TB, Kiyingi J, Huang KY, McKay MM. The Post-intervention Impact of Amaka Amasanyufu on Behavioral and Mental Health Functioning of Children and Adolescents in Low-Resource Communities in Uganda: Analysis of a Cluster-Randomized Trial From the SMART Africa-Uganda Study (2016-2022). J Adolesc Health. 2023 May;72(5S):S3-S10. doi: 10.1016/j.jadohealth.2022.09.035.

  PMID: 37062581 DERIVED

• Brathwaite R, Sensoy Bahar O, Mutumba M, Byansi W, Namatovu P, Namuwonge F, Neilands TB, McKay MM, Hoagwood KE, Ssewamala FM. Short-Term Impact of "Amaka Amasanyufu" Multiple Family Group Intervention on Mental Health Functioning of Children With Disruptive Behavior Disorders in Uganda. J Am Acad Child Adolesc Psychiatry. 2023 Jul;62(7):777-790. doi: 10.1016/j.jaac.2022.12.028. Epub 2023 Mar 8.

  PMID: 36898607 DERIVED

• 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.

  PMID: 34989404 DERIVED

• 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.

  PMID: 33430647 DERIVED

• 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.

  PMID: 30081967 DERIVED

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Mary McKay, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Fred Ssewamala, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: March 16, 2017
• Study Start: October 6, 2017
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); KE (1); UG (1); GH (1)