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

NCT ID: NCT07240792

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-05
• Study Completion Date: 2027-06-30

Brief Summary

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.

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.

Conditions

Depression; Anxiety; Stress

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Student Delivered Cognitive Behavioral Therapy Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jamal Essayli

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

27316

Identifier Type: -

Identifier Source: org_study_id