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

Mental Health Issue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05955898
• Other study ID #: 20230552
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 17, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Distress, Emotional
• Mental Health Issue
• Parents

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Miami	Coral Gables	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (9)

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.

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Overall Anxiety Severity and Impairment Scale (OASIS) scores	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
Secondary	Change in Overall Depression Severity and Impairment Scale (ODSIS) scores	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
Secondary	Change in Parental Acceptance and Action Questionnaire (PAAQ) scores	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