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

NCT03243396 | Completed Results DMC

• 2 other identifiers: Pro000819131R01MH112633
• Study Type: interventional
• Target: 956
• Locations: 1 country
• Sites: 1

Brief Summary

The BASIC study will take place in Kanduyi/Bungoma South Sub-County, in western 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 higher risk of mental health problems, 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-shifting approach, in which lay counselors with little or no prior mental health experience are trained to provide treatment, and deliver with supervision. However, very little is known about how to support local systems and organizations in delivering mental health care via task-shifting, particularly in a way that could scale-able and sustainable in the low-resource context. The BASIC team's prior work suggests that partnering with two government sectors, education and health, could be a low-cost and sustainable strategy to implement task-shifted 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 attempting any country or system-wide implementation, it is important to know what is needed to enable successful implementation in either or both sectors, client outcomes for those receiving mental health care when delivered via Education or Health, and cost of delivery in both sectors. The team aims to collect outcomes that are relevant to policy makers, and that can be considered along with cost and experiences in both sectors.

Conditions

Grief; Post Traumatic Stress Disorder; Depression

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Change in Posttraumatic Stress Symptoms (Child Report)

  Severity of posttraumatic stress symptoms, as assessed by the Child and Adolescent Trauma Screen (child report), including additional items validated locally. Higher scores represent more severe symptoms. The range of scores is 0 to 66. Scores are the sum of 22 items asking about how often specific things have bothered someone in the past 4 weeks. Each item is measured on a scale of 0 to 3, where 0=never happens and 3=almost always.

  Baseline, End of 8-session Treatment (assessed up to 18 weeks)

• Fidelity

  Ability of the group leader to adhere to established Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) protocols and guidelines, as assessed by the Fidelity and Adherence Rating Scales developed by the study team. Assessed in each observed TF-CBT session by supervisors. Higher scores represent higher adherence to TF-CBT. Adherence is measured on a scale of 0 to 6. Scores reported are observations of Child groups.

  End of first year of site implementation (2 groups, 8 sessions each)

• Number of Sites That Adopted the Intervention

  Adoption is a binary yes/no outcome defined as initiating and delivering the 8-session TF-CBT groups by a 3-counselor team and is measured by counselor self-report (and confirmed by supervisors who observed groups). Assessed for each "trimester" end for schools and communities, summarized over the year. We report the number of sites out of 40 total that adopted the intervention.

  End of first year of site implementation (2 groups, 8 sessions each)

• Number of Sites That Sustained the Intervention

  Sustainment is a binary yes/no outcome defined as maintained delivery 2 years after the study intervention period (2 groups delivered within a calendar year, with at least 80% capacity as compared to their group enrollment during initial implementation). It is measured by counselor self-report (and confirmed by supervisors). At times the number of youth that would be 80% enrolled required rounding down to the nearest whole person. We report the number of sites out of 40 total that sustained the intervention.

  Two years after the first TF-CBT groups for each site

Secondary Outcomes (11)

• Change in Posttraumatic Stress Symptoms (Caregiver Report)

  Baseline, End of 8-session Treatment (assessed up to 18 weeks)

• Change in Depressive Symptoms (Child Report)

  Baseline, End of 8-session Treatment (assessed up to 18 weeks)

• Change in Grief (Child Report)

  Baseline, End of 8-session Treatment (assessed up to 18 weeks)

• TF-CBT Knowledge Score

  Immediately Post-Training (on final day of training for the sequence, up to 6 days)

• Change in Prosocial Behavior (Child Report)

  Baseline, End of 8-session Treatment (assessed up to 18 weeks)

Other Outcomes (6)

• Relationship Closeness

  End of 8-session Treatment (assessed up to 18 weeks)

• Relationship Conflict

  End of 8-session Treatment (assessed up to 18 weeks)

• Guardian-provided Social Support

  End of 8-session Treatment (assessed up to 18 weeks)

Study Arms (2)

Health-Sector Delivered CBT

EXPERIMENTAL

These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in a community setting from Community Health Volunteers.

Behavioral: Trauma-Focused Cognitive Behavioral Therapy

Education-Sector Delivered CBT

EXPERIMENTAL

These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in their school setting from teachers employed by their school.

Behavioral: Trauma-Focused Cognitive Behavioral Therapy

Interventions

Trauma-Focused Cognitive Behavioral Therapy BEHAVIORAL

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).

Also known as: Pamoja Tunaweza

Education-Sector Delivered CBT; Health-Sector Delivered CBT

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• University of Washington: collaborator
• Johns Hopkins University: collaborator
• Ace Africa: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

ACE Africa

Bungoma, Bungoma County, Kenya

Location

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MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Psychological Well-Being; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Results Point of Contact

• Title: Kathryn Whetten, PhD, MPH
• Organization: Duke University

k.whetten@duke.edu

919-613-5313

Study Officials

• Kathryn Whetten, PhD

  Center for Health Policy and Inequalities Research at Duke University

  PRINCIPAL INVESTIGATOR

• Shannon Dorsey, PhD

  University of Washington Department of Psychology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking--Child/Adolescent participants and their participating guardian will be able to tell to which arm they were allocated or randomized, given that they know from whom they receive treatment (from teachers, indicating Education or from Community Health Volunteers, indicating Health). There are other participant types in addition to children/adolescents and guardians who are enrolled in BASIC (per above description) to answer implementation questions (Aims 1 and 2 of BASIC). As noted above, these other participants include the lay counselors (teachers and Community Health Volunteers, their site leaders \[Education: Head Teachers and Deputy Teachers; Health: Community Health Extension Workers\]).
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Child mental health outcomes are assessed using an incomplete stepped wedge, cluster randomized controlled trial with 7 sequences. Child participants \& one guardian each are randomized to receive the treatment (therapy sessions) from lay counselors in the Health (Community Health Volunteer) or Education (teacher) sector, with timing based on the sequence to which their village cluster was randomly assigned. These participants are the focus of the Interventional Study Design in Aim 3. Also included are lay counselors \& site leaders (Head Teachers, Deputy Teachers, \& Community Health Extension Workers), given that it is a hybrid effectiveness-implementation trial. These participants, the focus of implementation questions in Aims 1 \& 2, provide TF-CBT \& do not receive therapy sessions themselves. The village clusters are randomized to sequences in the SW-CRT, \& if randomized to sequences 2-7, they receive coaching support informed by sequence 1 on how to effectively implement TF-CBT.

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: August 9, 2017
• Study Start: February 1, 2018
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2024
• Last Updated: April 1, 2025
• Results First Posted: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)