A Phase 1/2 interventional study of ACT for SCD in Race-related Stress, Depression, Anxiety and Quality of Life, sponsored by Children's Hospital Los Angeles. Recruiting at 1 site in United States. Open to participants aged 14 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Children's Hospital Los Angeles · Phase 1/2, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 66 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Children's Hospital Los Angeles is the lead sponsor of 150 studies on the registry; 46 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Youth Participant Inclusion and Exclusion Criteria The inclusion criteria for study participation are Be an adolescent and/or young adult (age 14-21) who has Sickle Cell Disease Willing to enroll in the ACT group jointly provided by the Division of Adolescent and Young Adult Medicine/Department of Hematology and Oncology Participants can be active, waitlisted, or new patients at CHLA Participants must be able to understand and speak English, as the therapy will only be delivered in English Participants must have an English-speaking parent/guardian Able to provide consent/assent An adolescent or young adult that is pregnant is eligible to participate if consent can be obtained Participants must be developmentally typical Have a stable internet connection (via computer, tablet, or phone) with access to a webcam and a private space to engage in a group therapy sessions; Must consent to audio and video recording of initial interview. Must agree to attend 6 weekly ACT group session Youth participants will be asked to become a member of the CAB. To become a CAB member, the youth participant must consent/assent to participation in the ACT intervention. If a CAB member, they must be willing to engage in CAB interviews and meetings.
The exclusion criteria are:
Prisoners or youth in detention centers Unable to understand or speak English Does not have SCD Clients who are at significant risk for suicide and self-injury will be excluded due to the intense levels of support required to support these individuals which would interfere with study procedures.
Adolescents with families that require frequent intervention from the Department of Children and Family Services, are currently experiencing psychosis, or have severe health concerns that will impact study participation or attendance will be excluded.
This study will use a 10-session ACT protocol to support Black adolescents and young adults in coping with race related stress.
Behavioral: ACT for SCD
Waitlist control group that will receive the intervention 3-4 months after the intervention group concludes.
Phase I Using a convenience sample, this study examines the feasibility and acceptability of a proposed 6-session ACT group intervention for Black youth with sickle cell disease (SCD), who experience compounded stress due to chronic illness and systemic inequities. A up to 11 youth and up to 11 parents/legal guardians will be enrolled in an ACT group offered via the Division of Adolescent and Young Adult Medicine. Participants will complete assessments at pre-, and post-intervention, and at a 3-month follow-up. Up to 5 of 11 parents/legal guardians and 5 of 11 youth (not required to be dyadic) will also be a part of the studies community advisory board (CAB) to ensure the intervention is culturally and developmentally responsive and grounded in community perspectives. Phase II Over the next 3 years this study will use a community-based participatory action research approach, extending and integrating feedback data collected in Phase I, to conduct a crossover waitlist-control trial.
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.
Time frame: 12 weeks
Sickle Cell Self-Efficacy Scale
a 9-item, self-administered questionnaire that measures an adult's confidence in managing sickle cell disease (SCD) day-to-day, including pain, emotions, and daily functioning.
Time frame: 6 mos
SCD Health-Related Internalized Stigma Scale
an 11-item tool assessing internalized stigma and other factors in sickle cell disease (SCD) patients
Time frame: 6 mos
Transition Readiness Assessment Questionnaire (TRAQ),
measure acquisition of transition readiness skills across the five stages of change
Time frame: 6 mos
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
Plan to share: No
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