Stress Physiology and Intervention Feasibility Among First Responder Parents

• Sponsor: Arizona State University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05875246
• Collaborator: Chapman University (Other)
• Enrollment: 100
• Locations: 2
• Arms: 3
• Anticipated Duration (Months): 5.8
• Patients Per Site: 50
• Patients Per Site Per Month: 8.5

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Stress; Parenting	Behavioral: Micro-interventions	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention 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 wearable30-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 (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Stress Physiology and Intervention Feasibility Among First Responder Parents
• Actual Study Start Date: Apr 5, 2023
• Anticipated Primary Completion Date: Sep 30, 2023
• Anticipated Study Completion Date: Sep 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Heart Rate Variability [30 days]

   HRV collected via wearables device

2. EMAs [30 days]

   Self-report of stress

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Responders State Wide	Clarksville	Kentucky	United States	40475
2	First Responders State Wide	Charlotte	Tennessee	United States	37036

Sponsors and Collaborators

• Arizona State University
• Chapman University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abigail Gewirtz, Professor, Arizona State University
• ClinicalTrials.gov Identifier: NCT05875246
• Other Study ID Numbers: STUDY00017540
• First Posted: May 25, 2023
• Last Update Posted: May 25, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 25, 2023