NCT04928001

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

January 30, 2025

Completed
Last Updated

January 30, 2025

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

June 9, 2021

Results QC Date

February 2, 2022

Last Update Submit

December 20, 2024

Conditions

Depression Anxiety and Co-occurring Rural Youth

Outcome Measures

Primary Outcomes (1)

  • Beck's Anxiety Inventory, Youth Version

    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

Study Arms (1)

Youth Thrive iCBT program

OTHER

Youth Thrive iCBT online program

Other: internet based iCBT program, Youth Thrive

Interventions

internet based iCBT program, Youth ThriveOTHER

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

Youth Thrive iCBT program

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • none.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montana State University

Bozeman, Montana, 59715, United States

Location

Related Publications (1)

  • 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).

    RESULT

Related Links

Results Point of Contact

Title
Dr. Katey T. Franklin
Organization
Montana State University
katey.franklin@montana.edu
406-570-6056

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: multiple baseline pre-post design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Teaching Professor

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 16, 2021

Study Start

February 17, 2021

Primary Completion

April 9, 2021

Study Completion

April 9, 2021

Last Updated

January 30, 2025

Results First Posted

January 30, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)