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

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ClinicalTrials.gov Identifier: NCT03081195
Recruitment Status : Recruiting
First Posted : March 16, 2017
Last Update Posted : March 5, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of Ghana
University of Nairobi
Reach the Youth Uganda
New York University
Information provided by (Responsible Party):
Fred Ssewamala, Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE February 23, 2017
First Posted Date  ICMJE March 16, 2017
Last Update Posted Date March 5, 2019
Actual Study Start Date  ICMJE October 6, 2017
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2019)
  • Child disruptive behavior [ Time Frame: baseline, 8 weeks, 16 weeks, 6 months ]
    Improvement in disruptive behavior will be measured by Iowa Connors and Impairment scale
  • Parenting [ Time Frame: baseline, 8 weeks, 16 weeks, 6 months ]
    Improvement in parenting will be measured by Alabama Parenting questionnaire
  • Social support [ Time Frame: baseline, 8 weeks, 16 weeks, 6 months ]
    Improvement in social support will be measured by Multidimensional scale of perceived social support -modified
  • Caregiver mental health [ Time Frame: baseline, 8 weeks, 16 weeks, 6 months ]
    Improvement in caregiver mental health will be measured by Center for Epidemiologic Studies Short Depression Scale, Brief Symptom Checklist, and parent stress index short form
  • Child mental health [ Time Frame: baseline, 8 weeks, 16 weeks, 6 months ]
    Improvement in Child mental health will be measured by Strengths and Difficulties questionnaire, tennessee self-concept, and child depression scale
  • Family relations [ Time Frame: baseline, 8 weeks, 16 weeks, 6 months ]
    Improvement in family relations will be measured by Family Relations and Cohesion scale
Original Primary Outcome Measures  ICMJE
 (submitted: March 15, 2017)
  • Child disruptive behavior [ Time Frame: baseline, 8 weeks, 16 weeks, 6 months ]
    Improvement in disruptive behavior will be measured by Iowa Connors
  • Parenting [ Time Frame: baseline, 8 weeks, 16 weeks, 6 months ]
    Improvement in parenting stress will be measured by Alabama Parenting questionnaire
  • Social support [ Time Frame: baseline, 8 weeks, 16 weeks, 6 months ]
    Improvement in social support will be measured by Multidimensional scale of perceived social support -modified
  • Caregiver depression [ Time Frame: baseline, 8 weeks, 16 weeks, 6 months ]
    Improvement in caregiver mental health will be measured by Center for Epidemiologic Studies Short Depression Scale
  • Child mental health [ Time Frame: baseline, 8 weeks, 16 weeks, 6 months ]
    Improvement in Child mental health will be measured by Strengths and Difficulties questionnaire
  • Child functioning [ Time Frame: baseline, 8 weeks, 16 weeks, 6 months ]
    Improvement in Child mental health will be measured by Impairment scale
  • Caregiver mental health [ Time Frame: baseline, 8 weeks, 16 weeks, 6 months ]
    Improvement in caregiver mental health will be measured by Brief Symptom Checklist short form
  • Parent stress [ Time Frame: baseline, 8 weeks, 16 weeks, 6 months ]
    Improvement in parental stress will be measured by parent stress index short form
  • Family relations [ Time Frame: baseline, 8 weeks, 16 weeks, 6 months ]
    Improvement in family relations will be measured by Family Relations and Cohesion scale
Change History Complete list of historical versions of study NCT03081195 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2019)
  • Implementation and Feasibility [ Time Frame: 8 weeks, 16 weeks, 6 months ]
    implementation and feasibility checklist measures
  • Fidelity [ Time Frame: 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 ]
    MFG Intervention Fidelity Assessment measures
  • Sustainability [ Time Frame: 8 weeks, 16 weeks, 6 months ]
    Program Sustainability Assessment Tool
  • Implementation process [ Time Frame: 8 weeks, 16 weeks, 6 months ]
    Metropolitan Area Child Study process measure
Original Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2017)
  • Implementation and Feasibility [ Time Frame: post-test at 16 weeks ]
    Implementation & Feasibility Checklist
  • Fidelity [ Time Frame: 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 ]
    MFG Intervention Fidelity Assessment measures
  • Sustainability [ Time Frame: post-test at 16 weeks ]
    Program Sustainability Assessment Tool
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SMART Africa (Strengthening Mental Health Research and Training)
Official Title  ICMJE SMART Africa: Addressing African Youth Mental Health by Scaling Family and Community-Level EBPs
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 treatment (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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Comparison Group
  • Multiple Family Groups by Parent Peers
  • Multiple Family Groups by Community Health Workers
Intervention  ICMJE 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)
Study Arms  ICMJE
  • 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

    Intervention: Behavioral: MFG
  • 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

    Intervention: Behavioral: MFG
  • 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

Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 1, 2019)
6870
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2017)
7366
Estimated Study Completion Date  ICMJE April 30, 2021
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fred M Ssewamala, PhD 314-935-5400 fms1@wustl.edu
Contact: Mary McKay, PhD 314-935-6693 mary.mckay@wustl.edu
Listed Location Countries  ICMJE Ghana,   Kenya,   Uganda,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03081195
Other Study ID Numbers  ICMJE U19MH110001-011
U19MH110001 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There will be no individual participant data that will be shared.
Responsible Party Fred Ssewamala, Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • University of Ghana
  • University of Nairobi
  • Reach the Youth Uganda
  • New York University
Investigators  ICMJE
Principal Investigator: Mary McKay, PhD Washington University School of Medicine
Principal Investigator: Fred Ssewamala, PhD Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP