Stress Physiology and Intervention Feasibility Among First Responder Parents

April 1, 2025 updated by: Abigail Gewirtz, Arizona State University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

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

  • United States
    • Kentucky
      • Clarksville, Kentucky, United States, 40475
        • First Responders State Wide
    • Tennessee
      • Charlotte, Tennessee, United States, 37036
        • First Responders State Wide

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group 1
Does not receive a micro-intervention
Experimental: Group 2
Receives brief messages for stress reduction.
Behavioral: Micro-interventions
Group 1: No intervention Group 2: Brief stress reduction messages Group 3: App based stress reduction audio activity
Experimental: Group 3
Directed to the app to listen to a stress reduction audio activity.
Behavioral: Micro-interventions
Group 1: No intervention Group 2: Brief stress reduction messages Group 3: App based stress reduction audio activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability
Time Frame: 30 days
HRV collected via wearables device
30 days
EMAs
Time Frame: 30 days
Self-report of stress
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arizona State University

Collaborators

Chapman University

Investigators

  • Principal Investigator: Abi Gewirtz, PhD, Arizona State University

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 5, 2023

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00017540

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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