Personalized Approach To Habits - Sleep

NCT07029919 | Completed

• 2 other identifiers: 2025-02-021R43HL174208-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Two arm study, intervention and control, to explore the impact of an app to help high risk teens with asthma improve their sleep

Conditions

Knowledge, Attitudes, Practice; Attitude; Adolescent Behavior; Sleep Disturbance; Asthma in Children; Habits

Keywords

Teens; Adolescents; Sleep; Asthma; Habits; Support for high risk teens

Outcome Measures

Primary Outcomes (8)

• Knowledge Pretest Score

  Investigators will ask participants 8 multiple choice knowledge questions related to sleep health and habits which investigators will average to create a composite knowledge score for each participant ranging from 0 to 100. A score of 0 means a participant got zero questions correct while a score of 100 means a participant got all questions correct. Investigators will average these composite scores across all participants for both groups to create mean scores ranging from 0 to 100, the higher the score the more questions participants answer correctly.

  Baseline

• Knowledge Posttest Score

  Investigators will ask participants 8 multiple choice knowledge questions related to sleep health and habits which investigators will average to create a composite knowledge score for each participant ranging from 0 to 100. A score of 0 means a participant got zero questions correct while a score of 100 means a participant got all questions correct. Investigators will average these composite scores across all participants for both groups to create mean scores ranging from 0 to 100, the higher the score the more questions participants answer correctly.

  Posttest- 28 days

• Cues to Action Pretest Score

  Investigators will ask participants 9 Likert-type scale questions to measure cues to action, where they rate their level of agreement with various statements. Each answer choice rating will range from 1 to 10, with higher ratings representing higher perceptions of cues to action. Investigators will average ratings from each question to create an average composite rating for each participant ranging from 1 to 10, with 1 being the lowest score and 10 being the highest. Higher score means better outcome. Then, investigators will average these composite scores for each group.

  Baseline

• Cues to Action Posttest Score

  Investigators will ask participants 9 Likert-type scale questions to measure cues to action, where they rate their level of agreement with various statements. Each answer choice rating will range from 1 to 10, with higher ratings representing higher perceptions of cues to action. Investigators will average ratings from each question to create an average composite rating for each participant ranging from 1 to 10, with 1 being the lowest score and 10 being the highest. Higher score means better outcome. Then, investigators will average these composite scores for each group.

  Posttest- 28 days

• Self-efficacy Pretest Score

  Investigators will ask participants 6 Likert-type scale questions related to perceived self-efficacy with improving sleep health. Each rating will range from 1 to 10, with higher ratings representing higher perceptions of confidence in improving sleep health. Investigators will average ratings from each question to create an average composite rating for each participant ranging from 1 to 10, with 1 being the lowest possible score and 10 being the highest score. Higher scores mean better outcomes. Then, investigators will average these composite scores for both groups.

  Baseline

• Self-efficacy Posttest Score

  Investigators will ask participants 6 Likert-type scale questions related to perceived self-efficacy with improving sleep health. Each rating will range from 1 to 10, with higher ratings representing higher perceptions of confidence in improving sleep health. Investigators will average ratings from each question to create an average composite rating for each participant ranging from 1 to 10, with 1 being the lowest possible score and 10 being the highest score. Higher scores mean better outcomes. Then, investigators will average these composite scores for both groups

  Posttest- 28 days

• Sleepiness/Restfulness Pretest Score

  Investigators will ask participants 5 Likert-type scale questions related to perceived sleepiness or tiredness during different situations. Each rating will range from 1 to 4, with higher ratings representing higher perceptions of tiredness. Investigators will average ratings from each question to create an average composite rating for each participant ranging from 1 to 4, with 1 being the lowest possible score and 4 being the highest score. Lower scores mean better outcomes. Then, investigators will average these composite scores for both groups.

  Baseline

• Sleepiness/Restfulness Posttest Score

  Investigators will ask participants 5 Likert-type scale questions related to perceived sleepiness or tiredness during different situations. Each rating will range from 1 to 4, with higher ratings representing higher perceptions of tiredness. Investigators will average ratings from each question to create an average composite rating for each participant ranging from 1 to 4, with 1 being the lowest possible score and 4 being the highest score. Lower scores mean better outcomes. Then, investigators will average these composite scores for both groups.

  Posttest- 28 days

Secondary Outcomes (1)

• Satisfaction at Posttest Score

  Posttest- 28 days

Other Outcomes (4)

• Change in Knowledge Scores from Pretest to Posttest

  Posttest- 28 days

• Change in Cues to Action Scores from Pretest to Posttest

  Posttest- 28 days

• Change in Self-Efficacy Scores From Pretest to Posttest

  Posttest- 28 days

Study Arms (2)

PATH-S Treatment

EXPERIMENTAL

Teens in the treatment group will be exposed to the educational material on the PATH-S app. They will engage with the app, log daily habits and sleep, and complete pretest and posttest assessments to measure changes in their knowledge, attitudes, intentions and self-efficacy.

Behavioral: PATH-S app

Control

NO INTERVENTION

Teens in the control group will not be exposed to the educational material on the PATH-S app. They will engage with the app, continue their usual schedules without the additional educational material, and complete pretest and posttest assessments to measure changes in their knowledge, attitudes, intentions and self-efficacy.

Interventions

PATH-S app BEHAVIORAL

PATH-S will use casual gaming and intermittent reinforcement techniques to encourage high risk teens to adopt and persist with personalized habits to improve sleep.

PATH-S Treatment

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Must be between 14 and 17 years old.
• Have an asthma diagnosis from a healthcare provider.
• Speak and understand English.
• Have access to a computer and the Internet.
• Have a smartphone and the ability to download and use an app.
• Live in the United States.

You may not qualify if:

• None

Sponsors & Collaborators

• KDH Research & Communication: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

KDH Research & Communication

Atlanta, Georgia, 30309, United States

Location

MeSH Terms

Conditions

Adolescent Behavior; Parasomnias; Behavior; Habits; Asthma

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Eric C. Tombly, PhD

  KDH Research & Communication

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Teens will be randomly assigned to either the treatment group, which will be exposed to educational material on the Personalized Approach To Habits - Sleep (PATH-S app), or the control group, which will not be exposed to educational material on the PATH-S app during the study period. Both groups will complete pretest and posttest assessments.

Study Record Dates

• First Submitted: June 7, 2025
• First Posted: June 19, 2025
• Study Start: July 9, 2025
• Primary Completion: January 30, 2026
• Study Completion: February 28, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)