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Completed

NCT Number: NCT03081195

SMART Africa (Strengthening Mental Health Research and Training)

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.

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Key information

Age range

8 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ghana, Accra, Ghana

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About this study

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

  • 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.
  • 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

  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MFG

Behavioral

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)

Primary outcomes

  1. Child disruptive behavior

    Time frame: baseline, 8 weeks, 16 weeks, 6 months

    Change in disruptive behavior will be measured by Iowa Connors

  2. Child impairment

    Time frame: baseline, 8 weeks, 16 weeks, 6 months

    Change in disruptive behavior will be measured Impairment scale

Secondary outcomes

  1. Implementation and Feasibility

    Time frame: 8 weeks, 16 weeks, 6 months

    implementation and feasibility checklist measures

  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: 8 weeks, 16 weeks, 6 months

    Program Sustainability Assessment Tool

  4. Implementation process

    Time frame: 8 weeks, 16 weeks, 6 months

    Metropolitan Area Child Study process measure

  5. Parenting

    Time frame: baseline, 8 weeks, 16 weeks, 6 months

    Change in parenting will be measured by Alabama Parenting questionnaire

  6. 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

  7. Caregiver depression

    Time frame: baseline, 8 weeks, 16 weeks, 6 months

    Change in caregiver depression will be measured by Center for Epidemiologic Studies Short Depression Scale

  8. Caregiver mental health

    Time frame: baseline, 8 weeks, 16 weeks, 6 months

    Change in caregiver mental health will be measured by Brief Symptom Checklist

  9. Caregiver stress

    Time frame: baseline, 8 weeks, 16 weeks, 6 months

    Change in caregiver stress will be measured by parent stress index short form

  10. Child mental health

    Time frame: baseline, 8 weeks, 16 weeks, 6 months

    Change in Child mental health will be measured by Strengths and Difficulties questionnaire

  11. Child self-concept

    Time frame: baseline, 8 weeks, 16 weeks, 6 months

    Change in child self-concept will be measured by tennessee self-concept

  12. Child depression

    Time frame: baseline, 8 weeks, 16 weeks, 6 months

    Change in child depression will be measured by child depression scale

  13. Family relations

    Time frame: baseline, 8 weeks, 16 weeks, 6 months

    Change in family relations will be measured by Family Relations and Cohesion scale

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • New York University
  • Reach the Youth Uganda
  • University of Ghana
  • University of Nairobi

Registry information

Official study title

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

Acronym: SMART

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 16, 2017
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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