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Trial record 45 of 137 for:    Mental Disorders | Recruiting, Not yet recruiting, Available Studies | "Mental Health"

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 : October 3, 2018
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

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

Condition or disease Intervention/treatment Phase
Child Behavior Problem Child Behavior Disorders Family Relations Behavioral: MFG Not Applicable

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, 300 youth and their caregivers (300) in Ghana, and 300 youth and their caregivers (300) 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; or, 3) Comparison: mental health and school support materials (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 : Interventional  (Clinical Trial)
Estimated Enrollment : 7366 participants
Allocation: Randomized
Intervention Model: Factorial 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, uniforms).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SMART Africa: Addressing African Youth Mental Health by Scaling Family and Community-Level EBPs
Actual Study Start Date : October 6, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
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

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
  • Happy Families

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

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
  • Happy Families

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




Primary Outcome Measures :
  1. 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

  2. Parenting [ Time Frame: baseline, 8 weeks, 16 weeks, 6 months ]
    Improvement in parenting stress will be measured by Alabama Parenting questionnaire

  3. 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

  4. 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

  5. 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

  6. Child functioning [ Time Frame: baseline, 8 weeks, 16 weeks, 6 months ]
    Improvement in Child mental health will be measured by Impairment scale

  7. 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

  8. Parent stress [ Time Frame: baseline, 8 weeks, 16 weeks, 6 months ]
    Improvement in parental stress will be measured by parent stress index short form

  9. Family relations [ Time Frame: baseline, 8 weeks, 16 weeks, 6 months ]
    Improvement in family relations will be measured by Family Relations and Cohesion scale


Secondary Outcome Measures :
  1. Implementation and Feasibility [ Time Frame: post-test at 16 weeks ]
    Implementation & Feasibility Checklist

  2. 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

  3. Sustainability [ Time Frame: post-test at 16 weeks ]
    Program Sustainability Assessment Tool



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081195


Contacts
Contact: Mary McKay, PhD 314-935-6693 mary.mckay@wustl.edu
Contact: Fred Ssewamala, PhD 314-935-5400 fms1@wustl.edu

Locations
United States, Missouri
Washington University in St. Louis Not yet recruiting
Saint Louis, Missouri, United States, 63130
Contact: Mary M McKay, PhD    314-935-6693    mary.mckay@wustl.edu   
Contact: Fred Ssewamala, PhD       fms1@wustl.edu   
Ghana
University of Ghana Not yet recruiting
Accra, Ghana
Contact: Abdallah Ibrahim, PhD       ibdallah4@gmail.com   
Contact: Emmanuel Asampong, PhD       asampong2000@yahoo.com   
Kenya
University of Nairobi Not yet recruiting
Nairobi, Kenya
Contact: Anne Mbwayo, PhD       annembwayo@gmail.com   
Contact: Manasi Kumar, PhD       m.kumar@ucl.ac.uk   
Uganda
Reach the Youth Uganda Recruiting
Masaka, Uganda
Contact: Apollo Kivumbi, MD, MPH         
Sponsors and Collaborators
Washington University School of Medicine
National Institute of Mental Health (NIMH)
University of Ghana
University of Nairobi
Reach the Youth Uganda
New York University
Investigators
Principal Investigator: Mary McKay, PhD Washington University School of Medicine
Principal Investigator: Fred Ssewamala, PhD Washington University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fred Ssewamala, Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03081195     History of Changes
Other Study ID Numbers: U19MH110001-011
U19MH110001 ( U.S. NIH Grant/Contract )
First Posted: March 16, 2017    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There will be no individual participant data that will be shared.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fred Ssewamala, Washington University School of Medicine:
child behavior
intervention
multiple family group
Sub Saharan Africa
caregivers

Additional relevant MeSH terms:
Mental Disorders
Problem Behavior
Child Behavior Disorders
Behavioral Symptoms
Neurodevelopmental Disorders