Acceptance and Commitment Therapy for Adolescents and Young Adults With Sickle Cell Disease (ACT for SCD)

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Depression, Anxiety; Stress Reaction; Race-related Stress
• Intervention / Treatment: Behavioral: ACT for SCD

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Xzania Lee, PhD; Phone Number: 323.361.4768; Email: xlee@chla.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Children's Hospital Los Angeles
      • Contact: Xzania W Lee, Ph.D.; Phone Number: 323-361-4768; Email: xlee@chla.usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acceptance Commitment Therapy; 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; 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.
No Intervention: Control Group; Waitlist control group that will receive the intervention 3-4 months after the intervention group concludes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	6 mos
SCD Health-Related Internalized Stigma Scale	an 11-item tool assessing internalized stigma and other factors in sickle cell disease (SCD) patients	6 mos
Transition Readiness Assessment Questionnaire (TRAQ),	measure acquisition of transition readiness skills across the five stages of change	6 mos

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Collaborators: University of Southern California & Children's Hospital Los Angeles (USC-CHLA)
• Investigators: Principal Investigator: Xzania Lee, PhD, Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Adolescents; Acceptance and Commitment Therapy; coping; African American; Black; race-related stress; racial trauma
• Additional Relevant MeSH Terms: Mental Disorders; Wounds and Injuries; Behavioral Symptoms; Fractures, Bone; Behavior; Anxiety Disorders; Depression; Fractures, Stress
• Other Study ID Numbers: CHLA-25-00201; KL2TR001854 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No