Implementing and Evaluating an Internet-based Cognitive Behavior Therapy Intervention in School Settings

NCT ID: NCT04928001

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-17
• Study Completion Date: 2021-04-09

Brief Summary

This research study examines rural youth's experience of an internet based cognitive behavioral therapy intervention, and their experience of symptoms of depression, anxiety and co-occurring disorders.

Detailed Description

In the United States, and rural Montana, a substantial health disparity exists for rural youths' mental health and mental health care access. In 2017, nearly a third of all Montana high school students reported being impacted by depression; 21% considered suicide compared to 17% nationally. Over 30% of Montana adolescents indicated drinking alcohol and 20% indicated using marijuana. Rural Montanans face enormous barriers to behavioral health care including low mental health care provider coverage, long distances to adequate care, and stigma. We have developed a culturally and developmentally appropriate Internet-based Cognitive Behavior Therapy (iCBT) program designed to teach skills that address mental and behavioral health challenges common to adolescents. Building on previous development and evaluation of an adult version of iCBT (Thrive), the investigators propose to pilot the newly developed youth version of Thrive (Y-T), a fully automated stand-alone program. Y-T will deliver CBT skills through educational, real life adolescent scenarios, and tailored feedback videos to address symptoms of depression, anxiety and co-occurring (addiction) behaviors. The investigators intend to conduct feasibility analyses of pilot study implementation in school communities. The investigators will document and assess organization-level facilitators and barriers that impact the study processes at each study site. Short-term goal for this research are to understand how to effectively conduct trials within school community settings and to obtain preliminary information on the acceptability and effectiveness of the Y-T program to address depression and anxiety symptoms, and addictive behaviors. The investigators will conduct post-intervention focus groups to assess the program as experienced by participants and insight on the extent of program engagement and learning. The investigators hypothesize that those using Y-T over an 8-week period will report markedly decreased scores on anxiety, depression, and addictive behaviors. The long-term goal is to conduct a larger trial of the program to determine the evidence of impact among youth. Provided that this research demonstrates such programs to be evidence-based, the investigators will work on a broader dissemination plan with the ultimate aim of decreasing mental and behavioral health and respective health care disparities among rural youth.

Conditions

Depression Anxiety and Co-occurring Rural Youth

Study Design

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

Study Groups

Youth Thrive iCBT program

Youth Thrive iCBT online program

Group Type: OTHER

internet based iCBT program, Youth Thrive

Intervention Type: OTHER

iCBT program is a skills program which teaches assertive communication, constructive thinking and rewarding activities

Interventions

internet based iCBT program, Youth Thrive

iCBT program is a skills program which teaches assertive communication, constructive thinking and rewarding activities

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• participants are youth enrolled in participating schools
• ages 13 - 18 years old
• have access to electronic device to access iCBT intervention

Exclusion Criteria

• none.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Montana State University

OTHER

Sponsor Role: lead

Responsible Party

Kathryn Franklin

Assistant Teaching Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Montana State University

Bozeman, Montana, United States

Countries

United States

References

Franklin K, Tribbit T. A Feasibility Study for Implementing and Evaluating an Internet-Based Cognitive Behavior Therapy Intervention in Rural School Settings and its Impact on Adolescent Mental and Behavioral Health. Chronicle of Rural Education. 2024; 2(1).

Reference Type: RESULT

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://ojs.library.okstate.edu/osu/index.php/chronicle-of-rural-education/article/view/9566

Link to published article and results

Other Identifiers

KF072420

Identifier Type: -

Identifier Source: org_study_id