Clinical Trial: SMART Africa (Strengthening Mental Health Research and Training)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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 Summary:

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; 7 to 11 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 att
    Sponsor: NYU Silver School of Social Work

    Current Primary Outcome:

    • 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: bas

      Original Primary Outcome: Same as current

      Current Secondary Outcome:

      • 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


      Original Secondary Outcome: Same as current

      Information By: NYU Silver School of Social Work

      Dates:
      Date Received: February 23, 2017
      Date Started: May 1, 2017
      Date Completion: April 30, 2020
      Last Updated: March 15, 2017
      Last Verified: March 2017