NCT05685368

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P75+ for phase_1

Timeline
37mo left

Started Apr 2025

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Apr 2025Jun 2029

First Submitted

Initial submission to the registry

January 5, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
2.2 years until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

4.2 years

First QC Date

January 5, 2023

Last Update Submit

April 30, 2026

Conditions

Keywords

BlackAfrican AmericanAdolescentsAcceptance and Commitment Therapyrace-related stressracial traumacoping

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Total Scores on Acceptance and Action Questionnaire-2

    12 weeks

  • Total Scores on Multidimensional Inventory of Black Identity-Teen (MIBI-t)

    12 weeks

  • Total Score on Patient Health Questionaire-9

    12 weeks

  • Total Score on General Anxiety Disorder-7

    12 weeks

Study Arms (2)

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.

Behavioral: ACT for SCD

Control Group

NO INTERVENTION

Waitlist control group that will receive the intervention 3-4 months after the intervention group concludes.

Interventions

ACT for SCDBEHAVIORAL

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.

Acceptance Commitment Therapy

Eligibility Criteria

Age14 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

MeSH Terms

Conditions

DepressionAnxiety DisordersFractures, Stress

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersFractures, BoneWounds and Injuries

Study Officials

  • Xzania Lee, PhD

    Children's Hospital Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xzania Lee, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 17, 2023

Study Start

April 1, 2025

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2029

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations