Stress Physiology and Intervention Feasibility Among First Responder Parents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-05

Study Completion Date

2024-09-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Stress Parenting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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 Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 1

Does not receive a micro-intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2

Receives brief messages for stress reduction.

Group Type EXPERIMENTAL

Micro-interventions

Intervention Type BEHAVIORAL

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

Group 3

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

Group Type EXPERIMENTAL

Micro-interventions

Intervention Type BEHAVIORAL

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

Interventions

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Micro-interventions

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes