NCT06132373

Brief Summary

Introduction: Mental health disorders are a leading cause of disability among youth globally, and this has been worsened by the COVID-19 pandemic. In low and middle-income countries like Kenya and in rural Indiana, there is an enormous treatment gap for youth mental disorders due to limited mental health care resources. Goals: The purpose of this project is to examine the implementation of community-based, peer-led management of mental health care screening, and treatment for adolescents in Eldoret, Kenya using the REAIM framework. Methods: We shall conduct a one-week training to peer-mentors on screening for common mental health problems using the SDQ, PHQ-9, GAD-7, and YTP and treating adolescents who screen positive using a 5 session Problem Solving Treatment (PST), an evidence-based treatment for common youth mental health problems. We will then select five of the peers to deliver the intervention under the supervision of the study team at the largest community-based youth drop-in center, Family Health Options Kenya (FHOK), in Eldoret, where the peers already provide mentorship to adolescents. We will use the REAIM Framework to assess the reach, effectiveness, adoption, implementation, and maintenance of this intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 27, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

July 20, 2025

Status Verified

May 1, 2024

Enrollment Period

8 months

First QC Date

November 1, 2023

Last Update Submit

July 16, 2025

Conditions

Keywords

Problem-solving therapyCommunity Mental Health ServicesAdolescentsKenya

Outcome Measures

Primary Outcomes (4)

  • Strengths and Difficulties Questionnaire (SDQ)

    This is a brief behavioral screening questionnaire for 2-17 year olds to assess mental health problems ( emotional symptoms, conduct problems, hyperactivity/inattention , peer relationship problems. social behavior). The overall SDQ score ranges from 0 to 50, with a higher score indicating abnormal behaviors.

    On enrollment, at end of PST and six month follow-up

  • Patient Health Questionnaire 9 (PHQ-9)

    This is a brief screening tool for depression. Scale is from 0 to 27 with a higher score being more severe disease.

    On enrollment, at end of PST and six month follow-up

  • Generalized Anxiety Disorder 7 (GAD-7)

    This is a tool for assessing generalized anxiety disorder. Scale is from 0 to 21 with a higher score being more severe disease.

    On enrollment, at end of PST and six month follow-up

  • Youth Top Problem (YTP)

    a brief idiographic instrument designed to help identify and monitor youth problems that are especially important from the perspectives of the youth and the caregiver

    On enrollment, at end of PST and six month follow-up

Study Arms (1)

Single arm study

EXPERIMENTAL

We will apply evidence-based Problem Solving Therapy (PST), a transdiagnostic, low-intensity approach shown to improve mental health problems among adolescents with demonstrated effectiveness in global settings. PST for adolescents is a brief 5 session individual treatment with demonstrated efficacy when delivered by lay providers. PST is theorized to function by increasing adolescent capacity to cope with perceived and experienced stress through the use of problem- and emotion- focused coping skills that then allow engagement in positive, healthy activities.

Behavioral: Peer delivered problem solving therapy

Interventions

PST uses a straightforward approach amenable to use in new settings given its focus on idiographic problems, therefore session content is driven by the adolescent's presenting problem causing the most distress or impairment. We will use the standardized, core steps of PST and existing manualized protocols including from the Friendship Bench study and the WHO protocol for Problem Management Plus. The peers will deliver PST through 5 structured counseling sessions of 30-60 minutes over a 4-6 week period. There are 5 core components of PST which including problem listing and identification, problem exploration, developing an action plan, implementation, and follow up. The components will be introduced in the first session and be reviewed in an iterative process across the session to help participants use this model for different problems.

Single arm study

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Meet any ONE of the following FOUR criteria: (1) a score a 5 or higher on the PHQ-9 OR (2) a score a 5 or higher on the GAD-7. Youth reporting suicidality on the PHQ-9 will be referred for mental health care and offered to enroll in PST.

You may not qualify if:

  • intoxicated from any substance
  • require urgent medical care
  • receiving another mental health intervention
  • show visible language difficulties (unable to understand assent process)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moi Teaching and Referral Hospital

Eldoret, Uasin Gishu County, Kenya

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Matthew Turissini, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: We will conduct a mixed-methods evaluation with peer providers, participants, and key delivery stakeholders such as FHOK staff. We will collect quantitative data from: (1) peer mentors prior to their training and during the delivery of screening and treatment, (2) participants prior to entering treatment and after treatment. We will track rates of retention, engagement, and attrition during screening and treatment delivery. Lastly, we will collect qualitative data including interviews with 10 purposively sampled participants and Focus Groups with peer mentors and key delivery stakeholders post-treatment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Medicine, Department of Medicine, Indiana University School of Medicine

Study Record Dates

First Submitted

November 1, 2023

First Posted

November 15, 2023

Study Start

June 27, 2023

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

July 20, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations