Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Acceptance and Commitment Therapy for Adolescents and Young Adults With Sickle Cell Disease

Using Acceptance and Commitment Therapy (ACT) to Promote Mental Health and Transition Readiness in Youth With Sickle Cell Disease: A Community-Based Participatory Action Research (CBPAR) Approach

Acceptance and Commitment Therapy for Adolescents and Young Adults With Sickle Cell Disease (NCT05685368) is a Phase 1 / Phase 2 interventional studying Race-related Stress and Depression, Anxiety, sponsored by Children's Hospital Los Angeles. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Race-related Stress, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 66 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Race-related Stress subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BEHAVIORAL

ACT for SCD

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Children's Hospital Los Angeles
Los Angeles, California, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05685368), the sponsor (Children's Hospital Los Angeles), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05685368 clinical trial studying?

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 wi… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05685368?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05685368?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05685368. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05685368. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.