- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07660133
TEPS for At-Risk Youth
June 16, 2026 updated by: Ashley Knapp, Northwestern University
Technology-Enabled Prevention Services for At-Risk Youth
The goal of this aim was to conduct a randomized pilot trial evaluating the feasibility and acceptability of the co-created digital mental health program for anxiety among youth with elevated anxiety.
Youth were recruited from local public libraries, and the program was integrated into the teen programming of library services.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
66
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
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University, Feinberg School of Medicine
-
-
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
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Aged 12-18 years, currently enrolled in high school
- Score 5 or above on the GAD-7
Exclusion Criteria:
- Participated in previous field usability trial
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Condition
|
This condition included going over the existing mental health services the library has and then choosing one of those services to participate in
Other Names:
|
|
Experimental: Intervention Condition
|
Digital mental health intervention focused on anxiety among youth, with one-week and one-month follow-ups
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability
Time Frame: Assessed at the time the online intervention was taken during the 1-week period between baseline and the 1-week follow-up. Only for intervention condition.
|
Program Feedback Questionnaire (PFQ)
|
Assessed at the time the online intervention was taken during the 1-week period between baseline and the 1-week follow-up. Only for intervention condition.
|
|
Feasibility of Participants Completing the Digital Intervention
Time Frame: Assessed at 1-week follow-up (if they started, completed, or did not complete the intervention over the 1 week period). Only intervention condition.
|
Completion of intervention by youth in the intervention condition
|
Assessed at 1-week follow-up (if they started, completed, or did not complete the intervention over the 1 week period). Only intervention condition.
|
|
Usability
Time Frame: Assessed at the time the online intervention was taken during the 1-week period between baseline and the 1-week follow-up. Only for intervention condition.
|
System Usability Scale
|
Assessed at the time the online intervention was taken during the 1-week period between baseline and the 1-week follow-up. Only for intervention condition.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety
Time Frame: Assessed at baseline, one-week follow-up and one-month follow-up for all participants
|
RCADS-25, anxiety subscale
|
Assessed at baseline, one-week follow-up and one-month follow-up for all participants
|
|
Avoidance
Time Frame: Assessed at baseline, one-week follow-up and one-month follow-up for all participants
|
Child-Report Measure of Behavioral Avoidance (CAMS)
|
Assessed at baseline, one-week follow-up and one-month follow-up for all participants
|
|
Emotion Regulation
Time Frame: Assessed at 1-week follow-up (if they started, completed, or did not complete the intervention over the 1 week period). Only intervention condition.
|
Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA)
|
Assessed at 1-week follow-up (if they started, completed, or did not complete the intervention over the 1 week period). Only intervention condition.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ashley A Knapp, MA; PhD, Northwestern University
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)
December 5, 2024
Primary Completion (Actual)
January 9, 2026
Study Completion (Actual)
January 30, 2026
Study Registration Dates
First Submitted
June 16, 2026
First Submitted That Met QC Criteria
June 16, 2026
First Posted (Actual)
June 22, 2026
Study Record Updates
Last Update Posted (Actual)
June 22, 2026
Last Update Submitted That Met QC Criteria
June 16, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00212314
- K01MH121854 (U.S. NIH Grant/Contract)
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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