NCT05685368 Acceptance and Commitment Therapy for Adolescents and Young Adults With Sickle Cell Disease
| NCT ID | NCT05685368 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Children's Hospital Los Angeles |
| Condition | Race-related Stress |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 66 participants in total. It began in 2025-04-01 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Xzania Lee, PhD
PRINCIPAL INVESTIGATOR
Children's Hospital Los Angeles
Frequently Asked Questions
Who can join the NCT05685368 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 21 Years, studying Race-related Stress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05685368 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05685368 currently recruiting?
Yes, NCT05685368 is actively recruiting participants. Contact the research team at xlee@chla.usc.edu for enrollment information.
Where is the NCT05685368 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT05685368 clinical trial?
NCT05685368 is sponsored by Children's Hospital Los Angeles. The principal investigator is Xzania Lee, PhD at Children's Hospital Los Angeles. The trial plans to enroll 66 participants.