- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05685368
Acceptance and Commitment Therapy (ACT) for Combating the Effects of Race-Related Stress Among Black Adolescents
November 3, 2023 updated by: Xzania Lee, Children's Hospital Los Angeles
The Healing Power of Acceptance: Evaluating the Efficacy of Acceptance and Commitment Therapy (ACT) in Combating the Effects of Race-Related Stress Among Black Adolescents
The current study seeks to build on previous research that demonstrates the efficacy of Acceptance and Commitment Therapy in combating stigma by investigating the feasibility and acceptability of a protocol to support Black adolescents and young adults in coping with race related stress.
The study will consist of a small, purposeful, non-randomized sample (N = 30) of clients enrolled into a 10-session Acceptance and Commitment Therapy group.
The group will be offered as part of regular clinical care at the Division of Adolescent and Young Adult Medicine.
Three consecutive groups will be run with approximately 8-10 participants in each group over the next year.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
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 Contact
- Name: Xzania Lee, PhD
- Phone Number: 323.361.4768
- Email: xlee@chla.usc.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90027
- Recruiting
- Children's Hospital Los Angeles
-
Contact:
- Xzania W Lee, Ph.D.
- Phone Number: 323-361-4768
- Email: xlee@chla.usc.edu
-
-
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
13 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Identify as Black/African American
- English-speaking
Exclusion Criteria:
- Prisoners or youth in detention centers will be excluded.
- Not capable of participating meaningfully in the assent/consent process.
- Being at significant risk for suicide and self-injury
- Currently experiencing psychosis
- Having severe health concerns that will impact study participation or attendance
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acceptance Commitment Therapy
This study will use a 10-session ACT protocol to support Black adolescents and young adults in coping with race related stress.
|
This intervention will be guided by: Payne, J. S. (2022).
Out of the Fire: Healing Black Trauma Caused by Systemic Racism Using Acceptance and commitment Therapy New Harbinger Publications, Inc.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Score on Index of Race-Related Stress (IRRS)-Brief Version
Time Frame: 12 weeks
|
Higher scores on this measure indicate greater race-related stress.
The minimum score on this measure is 0 and the maximum is 88.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Scores on Acceptance and Action Questionnaire-2
Time Frame: 12 weeks
|
Higher scores on this measure indicate greater psychological flexibility.
The minimum score on this measure is 7 and the maximum is 49.
|
12 weeks
|
Total Scores on Multidimensional Inventory of Black Identity-Teen (MIBI-t)
Time Frame: 12 weeks
|
Higher scores on this measure indicate stronger racial identity.
The minimum score on this measure is 21 and the maximum is 105.
|
12 weeks
|
Total Score on Patient Health Questionaire-9
Time Frame: 12 weeks
|
Higher scores indicate greater depression.
The minimum score on this measure is 0 and the maximum is 27.
|
12 weeks
|
Total Score on General Anxiety Disorder-7
Time Frame: 12 weeks
|
Higher scores indicate greater anxiety.
The minimum score on this measure is 0 and the maximum is 21.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xzania Lee, PhD, Children's Hospital Los Angeles
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)
August 28, 2023
Primary Completion (Estimated)
July 31, 2024
Study Completion (Estimated)
July 31, 2024
Study Registration Dates
First Submitted
January 5, 2023
First Submitted That Met QC Criteria
January 5, 2023
First Posted (Actual)
January 17, 2023
Study Record Updates
Last Update Posted (Actual)
November 7, 2023
Last Update Submitted That Met QC Criteria
November 3, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHLA-23-00089
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
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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