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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05685368
Other study ID # CHLA-23-00089
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 28, 2023
Est. completion date July 31, 2024

Study information

Verified date November 2023
Source Children's Hospital Los Angeles
Contact Xzania Lee, PhD
Phone 323.361.4768
Email xlee@chla.usc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date July 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 13 Years to 21 Years
Eligibility 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 Design


Intervention

Behavioral:
ACT for 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.

Locations

Country Name City State
United States Children's Hospital Los Angeles Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total Score on Index of Race-Related Stress (IRRS)-Brief Version 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 Total Scores on Acceptance and Action Questionnaire-2 Higher scores on this measure indicate greater psychological flexibility. The minimum score on this measure is 7 and the maximum is 49. 12 weeks
Secondary Total Scores on Multidimensional Inventory of Black Identity-Teen (MIBI-t) Higher scores on this measure indicate stronger racial identity. The minimum score on this measure is 21 and the maximum is 105. 12 weeks
Secondary Total Score on Patient Health Questionaire-9 Higher scores indicate greater depression. The minimum score on this measure is 0 and the maximum is 27. 12 weeks
Secondary Total Score on General Anxiety Disorder-7 Higher scores indicate greater anxiety. The minimum score on this measure is 0 and the maximum is 21. 12 weeks
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