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Trial record 34 of 200 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

Building and Sustaining Interventions for Children: Task-sharing Mental Health Care in Low-resource Settings (BASIC)

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ClinicalTrials.gov Identifier: NCT03243396
Recruitment Status : Not yet recruiting
First Posted : August 9, 2017
Last Update Posted : August 9, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The study will take place in Kanduyi, a sub-county in southern Kenya, and focuses on children orphaned by one or two parents. Growing evidence demonstrates that orphaned children in low- and middle-income countries are at high risk of post-traumatic stress, but mental health professionals are largely unavailable in this area.

Research suggests that some mental health treatments can be delivered effectively in low- and middle-income countries using a task sharing approach, in which lay counselors with little or no prior mental health experience are trained to provide treatment.

Whetten and Dorsey's past studies have suggested that partnering with two government sectors, education and health, could be a low-cost and sustainable strategy to implement task sharing mental health services. By training teachers (via the education sector) and community health volunteers (via the health sector) to provide mental health care, a larger population could potentially be reached.

Before programs are scaled-up country-wide, it's important to know not only what policies to implement but also their predicted implementation success and intervention effectiveness. This study aims to identify implementation strategies and examine whether the education and/or health sectors are productive partners in scaling up task sharing mental health care in future programs.


Condition or disease Intervention/treatment
Grief Post Traumatic Stress Disorder Depression Behavioral: Trauma-Focused Cognitive Behavioral Therapy

Detailed Description:
Building and Sustaining Interventions for Children (BASIC): Task-sharing mental health care in low-resource settings builds on our 15-year history of collaborations with research partners in Kenya, prior NIH-funded work that identified mental health needs of orphaned children in low- and middle-income countries, and iterative and collaborative intervention adaptation and testing using a task-sharing approach, to address these needs. In BASIC, the investigator will test the implementation of Trauma-focused Cognitive Behavioral Therapy (TF-CBT), delivered via task-sharing, in two governmental sectors prioritized by our Kenyan partners as potential options for scale up— Education and Health Extension. The recent devolvement of the Kenyan government (leading to more local decision-making), the launch of a National Mental Health Policy, and our Kenyan partners' empowerment work building enthusiasm for TF-CBT are converging to create a local climate in which BASIC could become part of the county plan, if evidence-based guidance for implementation, using mostly existing resources, existed. The investigators test mental health treatment delivery in Education (via teacher delivery) and Health Extension (via community health volunteers) with the goal of identifying implementation practices and policies (IPPs) that explain implementation outcomes. This stepped wedge cluster randomized trial includes 40 schools and the 40 surrounding villages (120 lay counselors in each) who provide TF-CBT to 1,280 youth. The investigators use a novel method, qualitative comparative analyses (QCA), that holds potential for substantially advancing the field of implementation science. QCA leverages the rigor of quantitative approaches and the detail of qualitative approaches, and allows for complex causality and equifinality (i.e., an outcome can be reached by multiple means). Study aims are: 1) Identify actionable IPPs that predict adoption (delivery) and fidelity (high- quality delivery) after 10 sites in sector implement TF-CBT. Use identified IPPs to (Aim 1a) guide implementation planning support for subsequent sites and to (Aim 1b) generate testable hypotheses about IPPs as causal mechanisms; 2) Test mechanisms of implementation success in both sectors; and 3) Test TF-CBT effectiveness (i.e., mental health outcomes; functioning) and cost in both sectors. This research has important implications for implementing an evidence-based treatment in low-resource settings, including the US.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3072 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Stepped wedge with 7 steps; Participants are randomized to receive the treatment (therapy sessions) in either a community or school setting
Masking: None (Open Label)
Masking Description: No masking--Participants will be able to tell which arm they belong to based on where they are receiving the treatment (therapy sessions)
Primary Purpose: Treatment
Official Title: Building and Sustaining Interventions for Children (BASIC): Task-sharing Mental Health Care in Low-resource Settings
Anticipated Study Start Date : January 2018
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Community-Based CBT
These participants will receive Trauma-Focused Cognitive Behavioral Therapy in a community setting from community health volunteers
Behavioral: Trauma-Focused Cognitive Behavioral Therapy
Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).
Experimental: School-Based CBT
These participants will receive Trauma-Focused Cognitive Behavioral Therapy in a school setting from specified teachers
Behavioral: Trauma-Focused Cognitive Behavioral Therapy
Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).


Outcome Measures

Primary Outcome Measures :
  1. Trauma Severity [ Time Frame: 10 minutes ]
    Severity of trauma experienced by the child, as assessed by a composite of the Child and Adolescent Trauma Screen's child report and caregiver report

  2. Trauma Exposure [ Time Frame: 10 minutes ]
    Frequency of exposure of the child to common types of trauma, as assessed by a composite of the Trauma Exposure Screener's child report and caregiver report

  3. Strengths [ Time Frame: 15 minutes ]
    Behavioral strengths of the child, as assessed by a composite of the Strengths and Difficulties Questionnaire's child report and caregiver report

  4. Difficulties [ Time Frame: 15 minutes ]
    Behavioral difficulties of the child, as assessed by a composite of the Strengths and Difficulties Questionnaire's child report and caregiver report

  5. Functioning [ Time Frame: 5 minutes ]
    Level of social functioning of the child, as assessed by a composite of the Child and Adolescent Functioning's child report and caregiver report

  6. Relationship with Caregiver [ Time Frame: 5 minutes ]
    Quality of the child's relationship with their caregiver, as assessed by a composite of the Child and Adolescent Social Support Scale (child report) and the Child-Parent Relationship Scale (caregiver report)

  7. Grief [ Time Frame: 20 minutes ]
    Level of grief related to a traumatic event experienced by the child, as assessed by the Inventory of Complex Grief

  8. Mental Health [ Time Frame: 5 minutes ]
    Level of mental wellbeing of the child, as assessed by the Patient Health Questionnaire (8-question version)

  9. Risk Behavior [ Time Frame: 20 minutes ]
    Amount of risk behavior exhibited by the child, as assessed by the Safer Sex Peer Norms and Substance Use Questionnaire

  10. Child Labor [ Time Frame: 5 minutes ]
    Amount of labor required of the child in the past week, as assessed by the Child Work and Labor Questionnaire

  11. Social Support [ Time Frame: 10 minutes ]
    Amount of social support the child receives, as assessed by the Social Support Services Questionnaire

  12. Orphan Stigma [ Time Frame: 10 minutes ]
    Level of stigma experienced by the child as a result of their orphan status, as assessed by the Orphan Stigma and Social Mobility Questionnaire

  13. Exposure to CBT Sessions [ Time Frame: 2 minutes ]
    Exposure of the child to their assigned CBT sessions, as assessed by the Child Attendance Log (group leader records this)

  14. TF-CBT Feedback [ Time Frame: 45 minutes ]
    Opinions on the TF-CBT program, as assessed by the qualitative Semi-Structured Interview Guide's group leader and site leader reports

  15. Fidelity [ Time Frame: 20 minutes ]
    Ability of the group leader to adhere to established TF-CBT protocols and guidelines, as assessed by the Fidelity and Adherence Rating Scales

  16. TF-CBT Knowledge (group leader) [ Time Frame: 25 minutes ]
    Test of the level of knowledge of the group leader about TF-CBT, as assessed by the TF-CBT Knowledge Assessment

  17. TF-CBT Knowledge (site leader) [ Time Frame: 2 minutes ]
    Test of the level of knowledge of the site leader about TF-CBT, as assessed by the Organizational Questionnaire

  18. Adoption [ Time Frame: 5 minutes ]
    Level of uptake of the TF-CBT program by the organization, as assessed by a composite of the Organization Quantitative Questionnaire and the Provider Quantitative Questionnaire

  19. Acceptability [ Time Frame: 5 minutes ]
    Level to which the organization values the TF-CBT program, as assessed by a composite of the Organization Quantitative Questionnaire and the Provider Quantitative Questionnaire

  20. Appropriateness [ Time Frame: 10 minutes ]
    Level to which the organization sees the TF-CBT program as appropriate for their community, as assessed by a composite of the Organization Quantitative Questionnaire and the Provider Quantitative Questionnaire

  21. Feasibility [ Time Frame: 10 minutes ]
    Level to which the organization believes the TF-CBT program can be effectively delivered to their community, as assessed by a composite of the Organization Quantitative Questionnaire and the Provider Quantitative Questionnaire

  22. Reach [ Time Frame: 10 minutes ]
    Level of accessibility of the TF-CBT program to members of the community, as assessed by a composite of the Organization Quantitative Questionnaire and the Provider Quantitative Questionnaire

  23. Organizational Climate [ Time Frame: 10 minutes ]
    Conduciveness of the organization's climate to delivering the TF-CBT program, as assessed by a composite of the Organization Quantitative Questionnaire and the Provider Quantitative Questionnaire

  24. Implementation Leadership [ Time Frame: 5 minutes ]
    Level of ability of the organization's leaders to facilitate the delivery of the TF-CBT program, as assessed by a composite of the Organization Quantitative Questionnaire, the Provider Quantitative Questionnaire, the Group Leader Semi-Structured Interview, and the Site Leader Semi-Structured Interview

  25. General Leadership [ Time Frame: 5 minutes ]
    Level of ability of the organization's leaders to manage an effective workplace, as assessed by a composite of the Organization Quantitative Questionnaire and the Provider Quantitative Questionnaire

  26. Sustainability [ Time Frame: 30 minutes ]
    Likelihood that the TF-CBT program will continue to be delivered effectively beyond the study period, as assessed by a composite of the Organization Quantitative Questionnaire and the Program Sustainability Assessment Tool


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Child or young adolescent between the ages of 11 and 14 at the time of enrollment
  • Child lost one or both parents to death at least 6 months ago or later, and when the child was 4 years old or older
  • Child lives in the community with at least one adult guardian (18 years old or older)
  • Child is experiencing borderline or clinically significant levels of post-traumatic stress or childhood traumatic grief (as indicated by a score of 18 or higher on the Child Posttraumatic Stress Scale, or a score of 35 or higher on the Inventory of Complicated Grief)

Exclusion Criteria:

  • Child has a known developmental or cognitive disability
  • Child attends private school
  • Child and family are about to move
  • Children who lost a parent less than 6 months ago (since they may be experiencing a normal grief reaction and may not necessarily be in need of the treatment for CTG)
  • Caregiver of the child refuses to participate
  • Lay counselor is not literate
  • Lay counselor does not have a mobile phone
  • Lay counselor refuses to serve as a counselor
  • Site leader refuses to allow their site to participate in the study
Contacts and Locations

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): NCT03243396


Contacts
Contact: Andrew Weinhold, MPH 919-724-9503 akwein@duke.edu
Contact: Kelly Thompson, LICSW 206-543-5834 kelly3@uw.edu

Locations
Kenya
ACE Africa Not yet recruiting
Bungoma, Bungoma County, Kenya
Contact: Cyrilla Amanya    +254 (0) 72278509    cyrillaamanya@gmail.com   
Contact: Daisy Anyango       daisy.kwenda518@gmail.com   
Principal Investigator: Augustine I Wasonga         
Sponsors and Collaborators
Duke University
University of Washington
Johns Hopkins University
ACE Africa
Investigators
Principal Investigator: Kathryn Whetten, PhD Center for Health Policy and Inequalities Research at Duke University
Principal Investigator: Shannon Dorsey, PhD University of Washington Department of Psychology
More Information

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03243396     History of Changes
Other Study ID Numbers: Pro00081913
1R01MH112633 ( U.S. NIH Grant/Contract )
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Duke University:
Mental health
Mental health policy
Cognitive behavioral therapy
Task-shifting
Global health
Teacher
Community health volunteer
Children
Orphans
Abandoned children
TF-CBT
Ministry of Education
Ministry of Health
Delivery
Implementation science
Qualitative comparative analysis
Implementation practices and policies
Youth
Adoption
Fidelity
Kenya
Bungoma
Kanduyi
East Africa
Posttraumatic stress
Childhood traumatic grief
Grief
Trauma

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders