Clinical trial NCT05875246: Stress Physiology and Intervention Feasibility Among First Responder Parents
Official title: Stress Physiology and Intervention Feasibility Among First Responder Parents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Parenting
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Chapman University
First posted: 2023-05-25
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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 wearable
Primary purpose: OTHER

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).


Eligibility criteria: 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

Primary outcomes:
measure: Heart Rate Variability
timeFrame: 30 days
measure: EMAs
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Clarksville
country: United States
facility: First Responders State Wide
state: Kentucky
city: Charlotte
country: United States
facility: First Responders State Wide
state: Tennessee
Study officials:
affiliation: Arizona State University
name: Abi Gewirtz, PhD
role: PRINCIPAL_INVESTIGATOR
References: