StressNCT05875246
Stress Physiology and Intervention Feasibility Among First Responder Parents
A study testing Micro-interventions in people with Stress and Parenting, run by Arizona State University at 2 sites in United States.
Trial summary
The specific aims of this study are to: 1. Demonstrate the usability and acceptability of a smart watch in parents to remotely monitor stress responses or symptoms in individuals participating in prevention or treatment interventions. 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Micro-interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Apr 2023to 30 Sep 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have at least one child between the ages of 4 and 13 that resides with them in states of Kentucky or Tennessee
- Be able to wear a wrist-based wearable device
- Be able to read, write, and speak in English
- Not be allergic to polycarbonate or silicone
- Have a smart phone
- Work full time (at least 30 hours/week) as a first responder OR be a co-parent (defined as living in the same home and shares parenting responsibilities) of an eligible first responder
Who cannot join
- Do not have a child in the specified age range
- Have a child in the specified age range but who does not reside with them
- Are first responders who average less than 30 hours/week
- Are not a cohabitating parent
- Are a co-parent of eligible first responders who is not participating in the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
First Responders State Wide
Charlotte, Tennessee, 37036
First Responders State Wide
Clarksville, Kentucky, 40475
About this study
The specific aims of this study are to: 1. Demonstrate the usability and acceptability of a smart watch in parents to remotely monitor stress responses or symptoms in individuals participating in prevention or treatment interventions. 2. Examine the association between heart rate variability (HRV) data and momentary self-reports of stress by parents. 3. Conduct a feasibility study to establish the effectiveness of wearables and apps to improve emotion regulation in the short term (minutes, hours) and concomitant social, emotional, and behavioral outcomes over the longer-term (weeks).
- Being tested
- Micro-interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-interventionsBehavioural
Group 1: No intervention Group 2: Brief stress reduction messages Group 3: App based stress reduction audio activity
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | Does not receive a micro-intervention |
| Group 2 | Experimental | Receives brief messages for stress reduction. Receives: Behavioral: Micro-interventions |
| Group 3 | Experimental | Directed to the app to listen to a stress reduction audio activity. Receives: Behavioral: Micro-interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability
HRV collected via wearables device
Measured: 30 days
EMAs
Self-report of stress
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start5 Apr 2023
- Primary completion31 Jan 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 30-day cycle involving the EMA Questions, along the micro-Intervention randomization and delivery. The application is coded to randomize each participant to one of the three intervention options. During this 30-day cycle physiological data will be collected from the Garmin Vivosmart 5 device worn by the participant and loaded into the Labfront app for storage and retrieval. MYAPT.MIND (Daily for 30 days) * Ecological Momentary Assessment (EMA) Survey Questions Set #1 * Micro-Intervention (None, Brief Messages, MYAPT.MIND Audios) * Ecological Momentary Assessment (EMA) Survey Questions Set #2 * HRV (Heart Rate Variability) via Garmin Vivosmart 5 wrist wearable
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Chapman University
- Responsible party
- Principal investigator, Abigail Gewirtz, Arizona State University
- Investigators
- Abi Gewirtz, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875246
- Sponsor's protocol ID
- STUDY00017540
- Status last verified
- Apr 2025
- First submitted
- 16 May 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Physiology and Intervention Feasibility Among First Responder Parents
- ClinicalTrials.gov ID
- NCT05875246
- Acronym / sponsor ID
- STUDY00017540
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Chapman University
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 25 May 2023 (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.
The specific aims of this study are to: 1. Demonstrate the usability and acceptability of a smart watch in parents to remotely monitor stress responses or symptoms in individuals participating in prevention or treatment interventions. 2. Examine the association between heart rate variability (HRV) data and momentary self-reports of stress by parents. 3. Conduct a feasibility study to establish the effectiveness of wearables and apps to improve emotion regulation in the short term (minutes, hours) and concomitant social, emotional, and behavioral outcomes over the longer-term (weeks).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 30-day cycle involving the EMA Questions, along the micro-Intervention randomization and delivery. The application is coded to randomize each participant to one of the three intervention options. During this 30-day cycle physiological data will be collected from the Garmin Vivosmart 5 device worn by the participant and loaded into the Labfront app for storage and retrieval. MYAPT.MIND (Daily for 30 days) * Ecological Momentary Assessment (EMA) Survey Questions Set #1 * Micro-Intervention (None, Brief Messages, MYAPT.MIND Audios) * Ecological Momentary Assessment (EMA) Survey Questions Set #2 * HRV (Heart Rate Variability) via Garmin Vivosmart 5 wrist wearable
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –Does not receive a micro-intervention |
| Group 2 | Experimental | Behavioral: Micro-interventionsReceives brief messages for stress reduction. |
| Group 3 | Experimental | Behavioral: Micro-interventionsDirected to the app to listen to a stress reduction audio activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have at least one child between the ages of 4 and 13 that resides with them in states of Kentucky or Tennessee
- Be able to wear a wrist-based wearable device
- Be able to read, write, and speak in English
- Not be allergic to polycarbonate or silicone
- Have a smart phone
Key exclusion criteria (5 listed)
- Do not have a child in the specified age range
- Have a child in the specified age range but who does not reside with them
- Are first responders who average less than 30 hours/week
- Are not a cohabitating parent
- Are a co-parent of eligible first responders who is not participating in the study
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 |
|---|---|---|
| Micro-interventionsGroup 1: No intervention Group 2: Brief stress reduction messages Group 3: App based stress reduction audio activity | Behavioural | Group 2, Group 3 |
Primary outcome
Heart Rate Variability
Time frame: 30 days
HRV collected via wearables device
EMAs
Time frame: 30 days
Self-report of stress
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 3 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
Abi Gewirtz, PhD principal investigator
Arizona State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro-interventions in people with Stress and Parenting, run by Arizona State University at 2 sites 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 5 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 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Heart Rate Variability (time frame: 30 days). The study lists 2 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 3 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.