Development of a College Student-Delivered Cognitive-Behavioral Therapy (CBT) Intervention for Rural High School Students

April 14, 2026 updated by: Jamal Essayli, Milton S. Hershey Medical Center

Expanding Mental Health Access in Rural High Schools: Development and Testing of a College Student-Delivered Cognitive-Behavioral Therapy (CBT) Intervention

This research is being done to find out the effectiveness, feasibility, and acceptability of a college student-delivered cognitive-behavioral therapy (CBT) intervention in high schools in rural Schuylkill County, Pennsylvania to treat mental health problems (i.e. depression and anxiety) in adolescents. This project will respond to the need for evidence-based, acceptable, accessible, and low-cost adolescent cognitive-behavioral interventions that lead to long-term improvements in adolescents' mental health outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The overarching goal of this study is to iteratively adapt and test an innovative mental health delivery model that leverages college students to provide cognitive-behavioral therapy (CBT) to high school students in rural Schuylkill County, Pennsylvania. The investigators' preliminary data and established Community Advisory Board (CAB) support three key premises that drive this project. First, depression, anxiety, and stress are the most prevalent mental health challenges facing rural adolescents. Second, multiple barriers impede access to mental health care in rural communities, including provider shortages, mental health stigma, cost, insurance constraints, and limited parental knowledge or support. Third, these barriers can be addressed by enhancing school-based mental health services through a novel delivery model: licensed psychologists training undergraduate students to provide CBT interventions directly in high school settings.

Aim 1: Iteratively adapt and pilot CBT for high school students in rural Pennsylvania. The investigators will employ a systematic adaptation process guided by their preliminary data and the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME) to develop a culturally responsive and contextually appropriate CBT intervention for rural high school settings. This iterative refinement process will integrate feedback from two complementary sources: (1) semi-structured interviews with high school student participants and college student interventionists; and (2) a CAB comprising high school students, parents/caregivers, school mental health providers, school administrators, and college student interventionists. By the end of the two-year project period, the investigators will have developed a CBT intervention specifically tailored for high school students in rural Pennsylvania, with clear documentation of adaptation decisions and their empirical basis.

Aim 2: Examine the effects of the adapted CBT intervention on mental health outcomes among rural high school students. The investigators will evaluate preliminary effectiveness using self-report measures of depression, anxiety, and stress in 24-40 high school students (6-10 students/CBT group) across four implementation periods. Outcomes will be measured at pre-treatment, mid-treatment, and post-treatment. The investigators hypothesize that the adapted CBT intervention will result in at least a 50% decrease in mental health symptoms.

Aim 3: Evaluate the feasibility, acceptability, engagement, and fidelity of the adapted CBT intervention. The investigators will employ a mixed-methods approach to comprehensively evaluate four key implementation outcomes. Feasibility will be assessed through recruitment and retention metrics, while acceptability will be measured via standardized instruments and stakeholder feedback. Engagement will be tracked through session attendance and participation rates, and fidelity will be monitored through systematic assessment of intervention delivery. The investigators hypothesize that the adapted CBT intervention will meet or exceed pre-determined benchmarks across all implementation outcomes.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • High school students ages 13-18 years.
  • Attending a participating rural high school in Schuylkill County, Pennsylvania.

  • Presenting with self-reported symptoms of depression, anxiety, or stress. Must have a t-score ≥ 55 on one or more of the following three measures:

    i. PROMIS Emotional Distress Depression short-form questionnaire ii. PROMIS Emotional Distress Anxiety short-form questionnaire iii. PROMIS Psychological Stress Experiences short-form questionnaire

  • English-speaking (to ensure comprehension of CBT materials and assessments).

Exclusion Criteria:

  • Diagnosis of a psychotic disorder, bipolar disorder, intellectual disability, or seizure disorder.
  • Assessed to be at high risk for suicide or requiring immediate crisis intervention.
  • Inability to participate in school-based sessions due to scheduling conflicts or behavioral concerns.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Student Delivered Cognitive Behavioral Therapy (CBT) Intervention
The investigators will develop an intervention protocol drawing from evidence-based cognitive-behavioral therapy (CBT) components, including psychoeducation, behavioral activation, exposure therapy, cognitive restructuring, and problem solving, tailored to address the mental health needs in rural high school students and implemented by undergraduate college students.
Behavioral: Student Delivered Cognitive Behavioral Therapy Intervention
Our study aims to evaluate whether a 12-week cognitive-behavioral therapy (CBT) program delivered in both group and individual formats by trained college students can effectively help adolescents with symptoms of depression, anxiety, and stress. We will assess the program's feasibility, acceptability, and effectiveness in a high school setting. Sessions will cover topics such as: understanding connections between thoughts, feelings, and behaviors, identifying and challenging unhelpful thought patterns, using exposure principles to face feared situations, building problem-solving skills, and engaging in positive activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcomes Measurement Information System (PROMIS) 8-item Emotional Distress-Depression
Time Frame: Baseline, Week 6, Week 12
The Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression measure is an 8-item self-report questionnaire that examines depressive symptoms. Scores range from 8-40, with higher scores indicating higher levels of depression.
Baseline, Week 6, Week 12
PROMIS 8-item Emotional Distress-Anxiety
Time Frame: Baseline, Week 6, Week 12
The PROMIS Emotional Distress-Anxiety measure is an 8-item self-report questionnaire that examines anxiety symptoms. Scores range from 8-40, with higher scores indicating higher levels of anxiety.
Baseline, Week 6, Week 12
PROMIS 8-item Psychological Stress Experiences
Time Frame: Baseline, Week 6, Week 12
The PROMIS Psychological Stress Experiences measure is an 8-item self-report questionnaire that examines stress symptoms. Scores range from 8-40, with higher scores indicating higher levels of stress.
Baseline, Week 6, Week 12
Recruitment Rate
Time Frame: Through study completion, an average of 2 years
The investigators will determine the percent of participants recruited who consented to the study and attended the initial session.
Through study completion, an average of 2 years
Retention Rate
Time Frame: Through study completion, an average of 2 years
The investigators will determine the percent of participants consented who completed all study measures.
Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Engagement
Time Frame: Through study completion, an average of 2 years
The investigators will measure engagement through session attendance rates and session participation tracking.
Through study completion, an average of 2 years
Credibility/Expectancy Questionnaire (CEQ)
Time Frame: Week 6, Week 12
The Credibility/Expectancy Questionnaire (CEQ) is a 6-item questionnaire that examines the participants' perceptions of treatment credibility and their expectations for improvement. Scores range from 4-36 for questions 1, 2, 3, and 5. Questions 4 and 6 use a 0-100% scale. Higher scores indicate a more positive perception of the treatment and lower scores indicate a more negative perception of the treatment.
Week 6, Week 12
Intervention Fidelity
Time Frame: Through study completion, an average of 2 years
The investigators will measure intervention fidelity via systematic fidelity monitoring through an adapted CBT checklist completed by interventionists after each session. A random sample of sessions (20%) will be audio-recorded and rated by independent evaluators to verify self-reported fidelity.
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 21, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27316

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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