- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05955898
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
56
Phase
- 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 Locations
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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
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
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
Investigators
- 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
- Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337-45. doi: 10.1097/00004583-200111000-00015.
- Simons, J. S., & Gaher, R. M. (2005). The Distress Tolerance Scale: Development and validation of a self-report measure. Motivation and emotion, 29(2), 83-102.
- Bentley KH, Gallagher MW, Carl JR, Barlow DH. Development and validation of the Overall Depression Severity and Impairment Scale. Psychol Assess. 2014 Sep;26(3):815-830. doi: 10.1037/a0036216. Epub 2014 Apr 7.
- Norman SB, Cissell SH, Means-Christensen AJ, Stein MB. Development and validation of an Overall Anxiety Severity And Impairment Scale (OASIS). Depress Anxiety. 2006;23(4):245-9. doi: 10.1002/da.20182.
- Schleider JL, Dobias ML, Sung JY, Mullarkey MC. Future Directions in Single-Session Youth Mental Health Interventions. J Clin Child Adolesc Psychol. 2020 Mar-Apr;49(2):264-278. doi: 10.1080/15374416.2019.1683852. Epub 2019 Dec 4.
- Cheron DM, Ehrenreich JT, Pincus DB. Assessment of parental experiential avoidance in a clinical sample of children with anxiety disorders. Child Psychiatry Hum Dev. 2009 Sep;40(3):383-403. doi: 10.1007/s10578-009-0135-z. Epub 2009 Mar 12.
- Schleider, J. L., & Weisz, J. R. (2019). Sharing feelings project. Open Science Framework.
- Ehrenreich-May, J., Kennedy, S. M., Sherman, J. A., Bilek, E. L., Buzzella, B. A., Bennett, S. M., & Barlow, D. H. (2017). Unified protocols for transdiagnostic treatment of emotional disorders in children and adolescents: Therapist guide. Oxford University Press.
- Barlow, D. H., Farchione, T. J., Sauer-Zavala, S., Latin, H. M., Ellard, K. K., Bullis, J. R., ... & Cassiello-Robbins, C. (2017). Unified protocol for transdiagnostic treatment of emotional disorders: Therapist guide. Oxford University Press.
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)
May 17, 2024
Primary Completion (Actual)
June 24, 2024
Study Completion (Actual)
June 27, 2024
Study Registration Dates
First Submitted
June 18, 2023
First Submitted That Met QC Criteria
July 13, 2023
First Posted (Actual)
July 21, 2023
Study Record Updates
Last Update Posted (Actual)
July 11, 2025
Last Update Submitted That Met QC Criteria
July 9, 2025
Last Verified
September 1, 2024
More Information
Terms related to this study
Other Study ID 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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