Race-related StressPhase 1/2ACT for SCDNCT05685368
Acceptance and Commitment Therapy for Adolescents and Young Adults With Sickle Cell Disease
A Phase 1/2 study testing ACT for SCD in people with Race-related Stress and Depression, Anxiety, run by Children's Hospital Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 21 years
- Conditions the study is for
- Race-related Stress, Depression, Anxiety, Quality of Life
- What is being tested?
- ACT for SCD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 30 Jun 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Xzania W Lee, Ph.D., 323-361-4768, xlee@chla.usc.edu
About this study
Official title: 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
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.
- Being tested
- ACT for SCD
- Keywords
- Black, African American, Adolescents, Acceptance and Commitment Therapy, race-related stress, racial trauma, coping
- Medical subject headings
- Depression, Anxiety Disorders, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT for SCDBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance Commitment Therapy | Experimental | This study will use a 10-session ACT protocol to support Black adolescents and young adults in coping with race related stress. Receives: Behavioral: ACT for SCD |
| Control Group | No intervention | Waitlist control group that will receive the intervention 3-4 months after the intervention group concludes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 mos
SCD Health-Related Internalized Stigma Scale
an 11-item tool assessing internalized stigma and other factors in sickle cell disease (SCD) patients
Measured: 6 mos
Transition Readiness Assessment Questionnaire (TRAQ),
measure acquisition of transition readiness skills across the five stages of change
Measured: 6 mos
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Apr 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Race-related StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California & Children's Hospital Los Angeles (USC-CHLA)
- Responsible party
- Principal investigator, Xzania Lee, Children's Hospital Los Angeles
- Investigators
- Xzania Lee, PhD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685368
- Sponsor's protocol ID
- CHLA-25-00201
- Acronym
- ACT for SCD
- Status last verified
- Apr 2026
- First submitted
- 5 Jan 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05685368
- Acronym / sponsor ID
- ACT for SCD / CHLA-25-00201
- Keywords
- Black, African American, Adolescents, Acceptance and Commitment Therapy, race-related stress, racial trauma, coping
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- University of Southern California & Children's Hospital Los Angeles (USC-CHLA)
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance Commitment Therapy | Experimental | Behavioral: ACT for SCDThis study will use a 10-session ACT protocol to support Black adolescents and young adults in coping with race related stress. |
| Control Group | No intervention | –Waitlist control group that will receive the intervention 3-4 months after the intervention group concludes. |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT for SCDPhase 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. | Behavioural | Acceptance Commitment Therapy |
Primary outcome
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.
Sickle Cell Self-Efficacy Scale
Time frame: 6 mos
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.
SCD Health-Related Internalized Stigma Scale
Time frame: 6 mos
an 11-item tool assessing internalized stigma and other factors in sickle cell disease (SCD) patients
Transition Readiness Assessment Questionnaire (TRAQ),
Time frame: 6 mos
measure acquisition of transition readiness skills across the five stages of change
4 secondary outcomes
Total Scores on Acceptance and Action Questionnaire-2
Time frame: 12 weeks
Total Scores on Multidimensional Inventory of Black Identity-Teen (MIBI-t)
Time frame: 12 weeks
Total Score on Patient Health Questionaire-9
Time frame: 12 weeks
Total Score on General Anxiety Disorder-7
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
Related trials for Race-related Stress
Not yet recruiting
Racism-related Stress and Objective Short-sleep as Moderators of Treatment Effect in Cognitive Behavioral Therapy for Insomnia
Insomnia, Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xzania Lee, PhD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ACT for SCD in people with Race-related Stress and Depression, Anxiety, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xzania Lee, PhD (323.361.4768, xlee@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Score on Index of Race-Related Stress (IRRS)-Brief Version (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.