Stress Physiology and Intervention Feasibility Among First Responder Parents

Stress Clinical Trial

Official title:

Stress Physiology and Intervention Feasibility Among First Responder Parents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05875246
• Other study ID #: STUDY00017540
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2023
• Source: Arizona State University
• Contact: Amy Majerle, MA
• Phone: 6127305350
• Email: amy.majerle[@]asu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parenting
• Stress

Intervention

Behavioral:
• Micro-interventions
Group 1: No intervention Group 2: Brief stress reduction messages Group 3: App based stress reduction audio activity

Locations

Country	Name	City	State
United States	First Responders State Wide	Charlotte	Tennessee
United States	First Responders State Wide	Clarksville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Arizona State University	Chapman University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate Variability	HRV collected via wearables device	30 days
Primary	EMAs	Self-report of stress	30 days