Stress Physiology and Intervention Feasibility Among First Responder Parents

NCT05875246 | Completed

• 1 other identifier: STUDY00017540
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief 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. 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).

Conditions

Stress; Parenting

Outcome Measures

Primary Outcomes (2)

• Heart Rate Variability

  HRV collected via wearables device

  30 days

• EMAs

  Self-report of stress

  30 days

Study Arms (3)

Group 1

NO INTERVENTION

Does not receive a micro-intervention

Group 2

EXPERIMENTAL

Receives brief messages for stress reduction.

Behavioral: Micro-interventions

Group 3

EXPERIMENTAL

Directed to the app to listen to a stress reduction audio activity.

Behavioral: Micro-interventions

Interventions

Micro-interventions BEHAVIORAL

Group 1: No intervention Group 2: Brief stress reduction messages Group 3: App based stress reduction audio activity

Group 2; Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead
• Chapman University: collaborator

Study Sites (2)

First Responders State Wide

Clarksville, Kentucky, 40475, United States

Location

First Responders State Wide

Charlotte, Tennessee, 37036, United States

Location

Study Officials

• Abi Gewirtz, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: April 5, 2023
• Primary Completion: January 31, 2024
• Study Completion: September 30, 2024
• Last Updated: April 3, 2025

Record last verified: 2025-04

Locations

US (2)