NCT06840444

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

February 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

February 17, 2025

Last Update Submit

April 9, 2026

Conditions

InsomniaAdolescentDigital Health

Outcome Measures

Primary Outcomes (1)

  • Program Completion Percentage

    Immediately post-treatment

Secondary Outcomes (1)

  • Treatment Acceptability Ratings

    Immediately post-treatment

Study Arms (2)

Teen Advisory Board (TAB)/Beta Cohort 1

These teens will co-design and beta-test an app prototype.

Behavioral: Firefly Mobile App: A Digital Health Solution for Healthy Sleep in Teens

Beta Cohort 2

These teens will do the second round of beta-testing for the app prototype.

Behavioral: Firefly Mobile App: A Digital Health Solution for Healthy Sleep in Teens

Interventions

Firefly Mobile App: A Digital Health Solution for Healthy Sleep in TeensBEHAVIORAL

A six week cognitive behavioral therapy for insomnia program delivered via a mobile app.

Beta Cohort 2Teen Advisory Board (TAB)/Beta Cohort 1

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Youth with self-reported insomnia symptoms, aged 13-18.

You may qualify if:

  • years old
  • Self-reported insomnia symptoms

You may not qualify if:

  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kansas University Medical Center

Kansas City, Kansas, 66103, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2025

First Posted

February 21, 2025

Study Start

April 1, 2025

Primary Completion

August 1, 2025

Study Completion

December 1, 2025

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Locations

US(1)