ParentsNCT05955898
The Development and Evaluation of a Single Session Intervention for Parent Distress Tolerance
A study testing Parents THRIVE and Sharing Feelings Project in people with Parents and Mental Health Issue, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parents, Mental Health Issue, Distress, Emotional
- What is being tested?
- Parents THRIVE and Sharing Feelings Project
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2024to 27 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Failure to meet any of the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Parents, Mental Health Issue, Distress, Emotional
- Being tested
- Parents THRIVE, Sharing Feelings Project
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parents THRIVEBehavioural
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 ProjectBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sharing Feelings Project |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, up to three-week follow-up
Secondary outcomes (3)
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.
Measured: Baseline, up to three-week follow-up
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.
Measured: Baseline, up to three-week follow-up
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.
Measured: Baseline, up to three-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start17 May 2024
- Primary completion24 Jun 2024
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ParentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill May Ehrenreich, University of Miami
- Investigators
- Jill Ehrenreich-May, PhD, Principal investigator, University of MiamiElizabeth R Halliday, MS, Study chair, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955898
- Sponsor's protocol ID
- 20230552
- Status last verified
- Sep 2024
- First submitted
- 18 Jun 2023
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19280337Simons, 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.
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.
PubMed 16688739Bentley 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.
PubMed 24708078Goodman 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.
PubMed 11699809Schleider, J. L., & Weisz, J. R. (2019). Sharing feelings project. Open Science Framework.
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.
PubMed 31799863Ehrenreich-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 at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Evaluation of a Single Session Intervention for Parent Distress Tolerance
- ClinicalTrials.gov ID
- NCT05955898
- Acronym / sponsor ID
- 20230552
- Conditions
- Parents, Mental Health Issue, Distress, Emotional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 17 May 2024 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents THRIVE Group | Experimental | Behavioral: Parents THRIVEParticipants in this group will receive the Parents THRIVE intervention. Participants will be in this group for up to two hours. |
| Sharing Feelings Project Group | Active comparator | Behavioral: Sharing Feelings ProjectParticipants in this group will receive the Sharing Feelings Group intervention. Participants will be in this group for up to two hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Failure to meet any of the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parents THRIVEParents 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. | Behavioural | Parents THRIVE Group |
| Sharing Feelings ProjectSharing 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. | Behavioural | Sharing Feelings Project Group |
Primary outcome
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.
3 secondary outcomes
Change in Overall Anxiety Severity and Impairment Scale (OASIS) scores
Time frame: 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
Change in Parental Acceptance and Action Questionnaire (PAAQ) scores
Time frame: Baseline, up to three-week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Background: PubMed 19280337Cheron 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.
- BackgroundSimons, 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: PubMed 16688739Norman 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.
- Background: PubMed 24708078Bentley 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.
- Background: PubMed 11699809Goodman 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.
- BackgroundSchleider, J. L., & Weisz, J. R. (2019). Sharing feelings project. Open Science Framework.
- Background: PubMed 31799863Schleider 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.
- BackgroundEhrenreich-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.
- BackgroundBarlow, 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Ehrenreich-May, PhD principal investigator
University of Miami
Elizabeth R Halliday, MS study chair
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parents THRIVE and Sharing Feelings Project in people with Parents and Mental Health Issue, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Distress Tolerance Scale scores (time frame: Baseline, up to three-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05955898, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.