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Stress Physiology and Intervention Feasibility Among First Responder Parents

Stress Physiology and Intervention Feasibility Among First Responder Parents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05875246
Enrollment
132
Registered
2023-05-25
Start date
2023-04-05
Completion date
2024-09-30
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parenting, Stress

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).

Interventions

BEHAVIORALMicro-interventions

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

Sponsors

Chapman University
CollaboratorOTHER
Arizona State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Heart Rate Variability30 daysHRV collected via wearables device
EMAs30 daysSelf-report of stress

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026