Stress Physiology and Intervention Feasibility Among Firs... | NCT05875246

Studies
Stress Physiology and Intervention Feasibility Among First Responder Parents

NCT05875246

Sponsor

Arizona State University

Status

Completed

Last Update Posted

Apr 3, 2025Actual

Enrollment

132Actual

Phase

Not Applicable

Conditions

Stress
Parenting

Interventions

Micro-interventions

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 5, 2023Actual

Primary Completion Date

Jan 31, 2024Actual

Completion Date

Sep 30, 2024Actual

First Submitted Date

May 16, 2023

First Submission Date that Met QC Criteria

May 16, 2023

First Posted Date

May 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2025

Last Update Posted Date

Apr 3, 2025Actual

Name	Class
Chapman University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

132Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	No Intervention	Does not receive a micro-intervention
Group 2	Experimental	Receives brief messages for stress reduction.	Behavioral: Micro-interventions
Group 3	Experimental	Directed to the app to listen to a stress reduction audio activity.	Behavioral: Micro-interventions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Micro-interventions	Behavioral	Group 1: No intervention Group 2: Brief stress reduction messages Group 3: App based stress reduction audio activity	Group 2 Group 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Heart Rate Variability	HRV collected via wearables device	30 days
EMAs	Self-report of stress	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Abi Gewirtz, PhD	Arizona State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Responders State Wide		Clarksville	Kentucky	40475	United States
First Responders State Wide

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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