SMART Africa (Strengthening Mental Health Research and Training)
NCT ID: NCT03081195
Last Updated: 2024-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3117 participants
INTERVENTIONAL
2017-10-06
2021-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
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.
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
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.
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
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Child or caregiver refusal to participate
* Refusal to participate
* Refusal to participate
* Refusal to participate
8 Years
99 Years
ALL
No
Sponsors
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University of Ghana
OTHER
University of Nairobi
OTHER
Reach the Youth Uganda
OTHER
New York University
OTHER
National Institute of Mental Health (NIMH)
NIH
Washington University School of Medicine
OTHER
Responsible Party
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Fred Ssewamala
Professor
Principal Investigators
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Mary McKay, PhD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Fred Ssewamala, PhD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University in St. Louis
St Louis, Missouri, United States
University of Ghana
Accra, , Ghana
University of Nairobi
Nairobi, , Kenya
Reach the Youth Uganda
Masaka, , Uganda
Countries
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References
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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.
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.
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.
Other Identifiers
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U19MH110001-011
Identifier Type: -
Identifier Source: org_study_id
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