Adolescent BehaviorPATH-SNCT07029919
Personalized Approach To Habits - Sleep
A study testing PATH-S app in people with Adolescent Behavior and Sleep Disturbance, run by KDH Research & Communication at 1 site in United States.
Trial summary
Two arm study, intervention and control, to explore the impact of an app to help high risk teens with asthma improve their sleep Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior, Sleep Disturbance, Asthma in Children
- What is being tested?
- PATH-S app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
KDH Research & Communication
Atlanta, Georgia, 30309
About this study
Two arm study, intervention and control, to explore the impact of an app to help high risk teens with asthma improve their sleep
Read the detailed description
The investigators will use a randomized, two-group, pretest/posttest design to test the efficacy of the Personalized Approach To Habits - Sleep (PATH-S app) and explore the following research question: To what extent does exposure to the PATH-S app increase teens' knowledge, cues to action, perceived sleepiness, and self-efficacy related to improving sleep?
PATH-S will use casual gaming and intermittent reinforcement techniques to encourage teens to adopt and persist with personalized habits to improve sleep duration. Researchers worked with subject matter experts, physicians, and the intended audience to ensure the PATH-S app reflects the specific needs of high risk teens with asthma; minimize counter-productive duplications of services and resource expenditure; and create empowered opportunities for teens to improve their overall sleep and habits.
The Principal Investigator (PI), with input from the subject matter experts and physicians, developed necessary research materials, including the recruitment protocols, evaluation instrumentation, and human subjects consent materials . The PI also outlined the appropriate statistical analysis methods. All procedure documents were reviewed by the KDH Research \& Communication (KDHRC) Institutional Review Board before the evaluation launch.
Investigators will recruit participants through evaluation partners who will disseminate the study information to teens via electronic notifications and flyers. Evaluation partners include national asthma organizations. The notifications and flyers provide information about the goal of the study, participant eligibility, and a link to an eligibility form. Once a potential participant completes the eligibility form and s/he is eligible for the study, they will receive a link to a consent form located on a secure online platform.
After consent and enrollment into the study, teens will complete a pretest survey and be randomly assigned to the intervention or control group. The intervention group will be exposed to the PATH-S app, with educational material, and will complete an online posttest survey after 28 days. The control group participants will be exposed to a cloned copy of the PATH-S app, but without the educational material, and will complete an online posttest survey after 28 days. Participant responses to pretest and posttest survey measures will be linked using non-personal identifiers.
The investigators will download and export the data from Alchemer, along with data logged on the app, into encrypted Excel files and import the raw data into STATA. The investigators will match the pretest and posttest responses using the non-personal identifiers and conduct analyses to test for the effect of the PATH-S app exposure on changes in teens' knowledge, cues to action, perceived sleepiness, and self-efficacy related to improving sleep.
The initial feasibility criterion is: Statistically significant (p<0.05) and positive relationship between exposure to PATH-S app and increased knowledge among the intervention group in comparison to the control group.
- Conditions
- Adolescent Behavior, Sleep Disturbance, Asthma in Children, Knowledge, Attitudes, Practice, Attitude, Habits
- Being tested
- PATH-S app
- Keywords
- Teens, Adolescents, Sleep, Asthma, Habits, Support for high risk teens
- Medical subject headings
- Adolescent Behavior, Parasomnias, Behavior, Habits, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PATH-S appBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Posttest- 28 days
Secondary outcomes (1)
Satisfaction at Posttest Score
Investigators will ask only the intervention group participants 5 Likert-type scale questions related to their satisfaction with the PATH-S app. Each rating will range from 1 to 10, with higher scores representing higher satisfaction with the PATH-S app. Investigators will average ratings from each question to create an average composite rating for each intervention participant, then investigators will average these scores across the intervention group. Scores will range from 1 to 10, with higher scores meaning better satisfaction/outcome.
Measured: Posttest- 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start9 Jul 2025
- Primary completion30 Jan 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- KDH Research & Communication
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Eric C. Tombly, PhD, Principal investigator, KDH Research & Communication
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029919
- Sponsor's protocol ID
- 2025-02-02
- Other IDs
- 1R43HL174208-01
- Acronym
- PATH-S
- Status last verified
- Apr 2026
- First submitted
- 7 Jun 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Approach To Habits - Sleep
- ClinicalTrials.gov ID
- NCT07029919
- Acronym / sponsor ID
- PATH-S / 2025-02-02
- Conditions
- Adolescent Behavior, Sleep Disturbance, Asthma in Children, Knowledge, Attitudes, Practice, Attitude, Habits
- Keywords
- Teens, Adolescents, Sleep, Asthma, Habits, Support for high risk teens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- KDH Research & CommunicationIndustry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two arm study, intervention and control, to explore the impact of an app to help high risk teens with asthma improve their sleep
Detailed description
The investigators will use a randomized, two-group, pretest/posttest design to test the efficacy of the Personalized Approach To Habits - Sleep (PATH-S app) and explore the following research question: To what extent does exposure to the PATH-S app increase teens' knowledge, cues to action, perceived sleepiness, and self-efficacy related to improving sleep?
PATH-S will use casual gaming and intermittent reinforcement techniques to encourage teens to adopt and persist with personalized habits to improve sleep duration. Researchers worked with subject matter experts, physicians, and the intended audience to ensure the PATH-S app reflects the specific needs of high risk teens with asthma; minimize counter-productive duplications of services and resource expenditure; and create empowered opportunities for teens to improve their overall sleep and habits.
The Principal Investigator (PI), with input from the subject matter experts and physicians, developed necessary research materials, including the recruitment protocols, evaluation instrumentation, and human subjects consent materials . The PI also outlined the appropriate statistical analysis methods. All procedure documents were reviewed by the KDH Research \& Communication (KDHRC) Institutional Review Board before the evaluation launch.
Investigators will recruit participants through evaluation partners who will disseminate the study information to teens via electronic notifications and flyers. Evaluation partners include national asthma organizations. The notifications and flyers provide information about the goal of the study, participant eligibility, and a link to an eligibility form. Once a potential participant completes the eligibility form and s/he is eligible for the study, they will receive a link to a consent form located on a secure online platform.
After consent and enrollment into the study, teens will complete a pretest survey and be randomly assigned to the intervention or control group. The intervention group will be exposed to the PATH-S app, with educational material, and will complete an online posttest survey after 28 days. The control group participants will be exposed to a cloned copy of the PATH-S app, but without the educational material, and will complete an online posttest survey after 28 days. Participant responses to pretest and posttest survey measures will be linked using non-personal identifiers.
The investigators will download and export the data from Alchemer, along with data logged on the app, into encrypted Excel files and import the raw data into STATA. The investigators will match the pretest and posttest responses using the non-personal identifiers and conduct analyses to test for the effect of the PATH-S app exposure on changes in teens' knowledge, cues to action, perceived sleepiness, and self-efficacy related to improving sleep.
The initial feasibility criterion is: Statistically significant (p<0.05) and positive relationship between exposure to PATH-S app and increased knowledge among the intervention group in comparison to the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PATH-S Treatment | Experimental | Behavioral: PATH-S appTeens 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. |
| 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. |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PATH-S appPATH-S will use casual gaming and intermittent reinforcement techniques to encourage high risk teens to adopt and persist with personalized habits to improve sleep. | Behavioural | PATH-S Treatment |
Primary outcome
Knowledge Pretest Score
Time frame: Baseline
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.
Knowledge Posttest Score
Time frame: Posttest- 28 days
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.
Cues to Action Pretest Score
Time frame: Baseline
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.
Cues to Action Posttest Score
Time frame: Posttest- 28 days
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.
Self-efficacy Pretest Score
Time frame: Baseline
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.
Self-efficacy Posttest Score
Time frame: Posttest- 28 days
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
Sleepiness/Restfulness Pretest Score
Time frame: Baseline
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.
Sleepiness/Restfulness Posttest Score
Time frame: Posttest- 28 days
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.
1 secondary outcome
Satisfaction at Posttest Score
Time frame: Posttest- 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric C. Tombly, PhD principal investigator
KDH Research & Communication
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PATH-S app in people with Adolescent Behavior and Sleep Disturbance, run by KDH Research & Communication at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge Pretest Score (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.