- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06840444
Implementation & Dissemination of a Digital Health Intervention for Adolescent Sleep (Firefly)
April 9, 2026 updated by: University of Kansas Medical Center
The Firefly Mobile App: A Digital Health Solution for Healthy Sleep in Teens
The goal of this study is to form a Teen Advisory Board (TAB), who will partner with our study team to co-design a beta-test a new prototype of the Firefly program, a mobile-native insomnia cognitive behavioral therapy intervention for teens.
This new prototype will have addressed issues that adolescents who had used the first version of the program deemed to be barriers to engaging with the treatment.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
The aims of this study are to: 1) form a Teen Advisory Board (TAB) of teens with self-reported insomnia symptoms, 2) co-design a functional app prototype for sleep with TAB, 3) conduct two rounds of beta-testing to inform the iterative refinement of the app prototype.
Participants will include 40 youth and their parents; 10 youth will participate in the TAB and first round 1 of beta-testing, and a separate cohort of 30 youth will participate in a second round of beta-testing.
Youth will be ages 13-18 years and will have self-reported insomnia symptoms.
Study Type
Observational
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
-
-
Kansas
-
Kansas City, Kansas, United States, 66103
- Kansas University Medical Center
-
-
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
Sampling Method
Non-Probability Sample
Study Population
Youth with self-reported insomnia symptoms, aged 13-18.
Description
Inclusion Criteria:
- 13-18 years old
- Self-reported insomnia symptoms
Exclusion Criteria:
- Non-English speaking
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Teen Advisory Board (TAB)/Beta Cohort 1
These teens will co-design and beta-test an app prototype.
|
A six week cognitive behavioral therapy for insomnia program delivered via a mobile app.
|
|
Beta Cohort 2
These teens will do the second round of beta-testing for the app prototype.
|
A six week cognitive behavioral therapy for insomnia program delivered via a mobile app.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Program Completion Percentage
Time Frame: Immediately post-treatment
|
Immediately post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Treatment Acceptability Ratings
Time Frame: Immediately post-treatment
|
Immediately post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
April 1, 2025
Primary Completion (Actual)
August 1, 2025
Study Completion (Actual)
December 1, 2025
Study Registration Dates
First Submitted
February 17, 2025
First Submitted That Met QC Criteria
February 17, 2025
First Posted (Actual)
February 21, 2025
Study Record Updates
Last Update Posted (Actual)
April 14, 2026
Last Update Submitted That Met QC Criteria
April 9, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00161292
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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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