Clinical trial NCT03081195: SMART Africa (Strengthening Mental Health Research and Training)
Official title: SMART Africa: Addressing African Youth Mental Health by Scaling Family and Community-Level EBPs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Ghana
name: University of Nairobi
name: Reach the Youth Uganda
name: New York University
name: National Institute of Mental Health (NIMH)
First posted: 2017-03-16
Enrollment: 3117
Sex: ALL
Minimum age (years): 8
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Child disruptive behavior
timeFrame: baseline, 8 weeks, 16 weeks, 6 months
measure: Child impairment
timeFrame: baseline, 8 weeks, 16 weeks, 6 months
Secondary outcomes:
measure: Implementation and Feasibility
timeFrame: 8 weeks, 16 weeks, 6 months
measure: Fidelity
timeFrame: 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
measure: Sustainability
timeFrame: 8 weeks, 16 weeks, 6 months
measure: Implementation process
timeFrame: 8 weeks, 16 weeks, 6 months
measure: Parenting
timeFrame: baseline, 8 weeks, 16 weeks, 6 months
measure: Social support
timeFrame: baseline, 8 weeks, 16 weeks, 6 months
measure: Caregiver depression
timeFrame: baseline, 8 weeks, 16 weeks, 6 months
measure: Caregiver mental health
timeFrame: baseline, 8 weeks, 16 weeks, 6 months
measure: Caregiver stress
timeFrame: baseline, 8 weeks, 16 weeks, 6 months
measure: Child mental health
timeFrame: baseline, 8 weeks, 16 weeks, 6 months
measure: Child self-concept
timeFrame: baseline, 8 weeks, 16 weeks, 6 months
measure: Child depression
timeFrame: baseline, 8 weeks, 16 weeks, 6 months
measure: Family relations
timeFrame: baseline, 8 weeks, 16 weeks, 6 months
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Accra
country: Ghana
facility: University of Ghana
city: Nairobi
country: Kenya
facility: University of Nairobi
city: Masaka
country: Uganda
facility: Reach the Youth Uganda
Study officials:
affiliation: Washington University School of Medicine
name: Mary McKay, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Fred Ssewamala, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.