NCT05955898

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

May 17, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2024

Completed
Last Updated

July 11, 2025

Status Verified

September 1, 2024

Enrollment Period

1 month

First QC Date

June 18, 2023

Last Update Submit

July 9, 2025

Conditions

ParentsMental Health IssueDistress, Emotional

Outcome Measures

Primary Outcomes (1)

  • Change in Distress Tolerance Scale scores

    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 Outcomes (3)

  • Change in Overall Anxiety Severity and Impairment Scale (OASIS) scores

    Baseline, up to three-week follow-up

  • Change in Overall Depression Severity and Impairment Scale (ODSIS) scores

    Baseline, up to three-week follow-up

  • Change in Parental Acceptance and Action Questionnaire (PAAQ) scores

    Baseline, up to three-week follow-up

Study Arms (2)

Parents THRIVE Group

EXPERIMENTAL

Participants in this group will receive the Parents THRIVE intervention. Participants will be in this group for up to two hours.

Behavioral: Parents THRIVE

Sharing Feelings Project Group

ACTIVE COMPARATOR

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

Interventions

Parents THRIVEBEHAVIORAL

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.

Parents THRIVE Group
Sharing Feelings ProjectBEHAVIORAL

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.

Sharing Feelings Project Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

Related Publications (9)

  • 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.

    PMID: 19280337BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 16688739BACKGROUND

  • 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.

    PMID: 24708078BACKGROUND

  • 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.

    PMID: 11699809BACKGROUND

  • Schleider, J. L., & Weisz, J. R. (2019). Sharing feelings project. Open Science Framework.

    BACKGROUND

  • 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.

    PMID: 31799863BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

Study Officials

  • Jill Ehrenreich-May, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

  • Elizabeth R Halliday, MS

    University of Miami

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Associate Chair

Study Record Dates

First Submitted

June 18, 2023

First Posted

July 21, 2023

Study Start

May 17, 2024

Primary Completion

June 24, 2024

Study Completion

June 27, 2024

Last Updated

July 11, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)