SMART Africa (Strengthening Mental Health Research and Training)

Comparison Group Clinical Trial

— SMART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03081195
• Other study ID #: U19MH110001-011
• Secondary ID: U19MH110001
• Status: Completed
• Phase: N/A
• Start date: October 6, 2017
• Est. completion date: May 31, 2021

Study information

• Verified date: August 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3117
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Ghana	University of Ghana	Accra
Kenya	University of Nairobi	Nairobi
Uganda	Reach the Youth Uganda	Masaka
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (6)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Mental Health (NIMH), New York University, Reach the Youth Uganda, University of Ghana, University of Nairobi

Countries where clinical trial is conducted

United States,  Ghana,  Kenya,  Uganda, 

Outcome

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