- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04928001
Implementing and Evaluating an Internet-based Cognitive Behavior Therapy Intervention in School Settings
December 20, 2024 updated by: Kathryn Franklin, Montana State University
A Feasibility Study for Implementing and Evaluating an Internet-based Cognitive Behavior Therapy Intervention in School Settings and Its Impact on Adolescent Mental and Behavioral Health
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
67
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 Locations
-
-
Montana
-
Bozeman, Montana, United States, 59715
- Montana State University
-
-
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
13 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
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.
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: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Youth Thrive iCBT program
Youth Thrive iCBT online program
|
iCBT program is a skills program which teaches assertive communication, constructive thinking and rewarding activities
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck's Anxiety Inventory, Youth Version
Time Frame: 8 weeks
|
The inventory measures anxiety symptoms and utilizes T Scores.
52.45 indicates the population mean with a standard deviation of 11.4 55 or less minimal, average symptoms of anxiety 55-59 mild symptoms of anxiety 60-69 moderate symptoms of anxiety 70+ severe symptoms of anxiety
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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).
Helpful Links
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 17, 2021
Primary Completion (Actual)
April 9, 2021
Study Completion (Actual)
April 9, 2021
Study Registration Dates
First Submitted
June 9, 2021
First Submitted That Met QC Criteria
June 9, 2021
First Posted (Actual)
June 16, 2021
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 20, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KF072420
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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