The Development and Evaluation of a Single Session Intervention for Parent Distress Tolerance

July 9, 2025 updated by: Jill May Ehrenreich, University of Miami
The purpose of this study is to study different ways to help parents cope with strong emotions. The study team will be looking at how two different treatments help parents learn to manage strong emotions. These treatments are one session and are completed online, without a therapist, like an online training or class.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Elizabeth R Halliday, MS
  • Phone Number: 3052842712
  • Email: erh24@miami.edu

Study Locations

  • United States
    • Florida
      • Coral Gables, Florida, United States, 33146
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Live in the United States.
  • Parent of a child aged 6-17 years old who has received at least one counseling or mental health treatment session from a provider in the last 6 months will be eligible to participate.
  • Parent is not currently receiving psychotherapy or counseling for a mental health concern (or received such in the past six months).
  • Parent reported poor distress tolerance (DT). Poor DT will be defined as a score of less than 54 on the Distress Tolerance Scale.
  • Due to language limitations of the primary researcher, parents will be eligible if they comfortably speak and read in English.
  • Parents must have a mobile device (e.g., laptop, tablet, smart phone, etc.) or desktop computer and internet access sufficient for the delivery of the study assessments and intervention online.

Exclusion Criteria:

  • Failure to meet any of the inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Parents THRIVE Group
Participants in this group will receive the Parents THRIVE intervention. Participants will be in this group for up to two hours.
Behavioral: Parents THRIVE
Parents THRIVE is a digital, one-time intervention that will give parents strategies to cope with their emotions and improve their distress tolerance. Parents will learn how to increase their emotion awareness to better tolerate strong emotions, such as anxiety, sadness, anger, and frustration.
Active Comparator: Sharing Feelings Project Group
Participants in this group will receive the Sharing Feelings Group intervention. Participants will be in this group for up to two hours.
Behavioral: Sharing Feelings Project
Sharing Feelings Project is a digital, one-time program that focuses on the benefit of sharing emotions with others and will be used as a control. Parents will read about how sharing their emotions can be helpful and anecdotes from others' experiences sharing emotions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Distress Tolerance Scale scores
Time Frame: Baseline, up to three-week follow-up
The Distress Tolerance Scale is a 15-item self-report measure that measures the perceived capacity to tolerate distress from a multidimensional framework, including tolerance, appraisal, absorption, and regulation. Items are rated on a 1-5 Likert scale and then summed. Scores range from 15-75. Higher total scores indicate greater ability to tolerate distress.
Baseline, up to three-week follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Overall Anxiety Severity and Impairment Scale (OASIS) scores
Time Frame: Baseline, up to three-week follow-up
Measures overall anxiety severity and anxiety-related impairment due to any anxiety disorder. Total scores are computed by summing scores from all 5 items. Total score ranges from 0 to 20, with higher scores indicating higher severity and impairment of anxiety symptoms. Reduction in OASIS scores therefore indicates better outcome.
Baseline, up to three-week follow-up
Change in Overall Depression Severity and Impairment Scale (ODSIS) scores
Time Frame: Baseline, up to three-week follow-up
Measures severity and frequency of depressive symptoms and functional deficits in pleasurable activities due to the depressive symptomatology. The ODSIS consists of 5 self-report items rated from 0 to 4. Total score ranges from 0 to 20 with higher scores indicating greater depression-related severity and impairment.
Baseline, up to three-week follow-up
Change in Parental Acceptance and Action Questionnaire (PAAQ) scores
Time Frame: Baseline, up to three-week follow-up
A 19-item measure of parent experiential avoidance, or parental actions intended to control the form and frequency of their child's emotional experiences. Items are rated on a 7-point scale, with higher possible scores ranging from 19 to 133. Higher scores indicate less parental experiential avoidance and less effort to control child emotional experiences.
Baseline, up to three-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Miami

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jill Ehrenreich-May, PhD, University of Miami
  • Study Chair: Elizabeth R Halliday, MS, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 24, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 27, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20230552

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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