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

Sponsor

Montana State University (Other)

Overall Status

Completed

CT.gov ID

NCT04928001

Collaborator

(none)

Enrollment

Location

Arm

1.7

Actual Duration (Months)

41.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Anxiety and Co-occurring Rural Youth	Other: internet based iCBT program, Youth Thrive	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

multiple baseline pre-post designmultiple baseline pre-post design

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Feb 17, 2021

Actual Primary Completion Date :

Apr 9, 2021

Actual Study Completion Date :

Apr 9, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Youth Thrive iCBT program Youth Thrive iCBT online program	Other: internet based iCBT program, Youth Thrive iCBT program is a skills program which teaches assertive communication, constructive thinking and rewarding activities

Arm

Intervention/Treatment

Other: Youth Thrive iCBT program

Youth Thrive iCBT online program

Other: internet based iCBT program, Youth Thrive

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

Outcome Measures

Primary Outcome Measures

Beck's Depression Inventory, Youth Version [8 weeks]
measures depressive symptoms, 0 (low) - 60 (high)
Beck's Anxiety Inventory, Youth Version [8 weeks]
measures anxiety symptoms, 0 (low) - 60 (high)
Subtle Substance Abuse Screening Inventory (SASSI) Youth Version [8 weeks]
measures substance use probability (low or high)
Focus Groups [8 weeks]
Intention of groups to understand participants' experience in program

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montana State University	Bozeman	Montana	United States	59715

Sponsors and Collaborators

Montana State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kathryn, Assistant Teaching Professor, Montana State University

ClinicalTrials.gov Identifier:

NCT04928001

Other Study ID Numbers:

KF072420

First Posted:

Jun 16, 2021

Last Update Posted:

Jul 1, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depression

Study Results

No Results Posted as of Jul 1, 2021