Acceptance and Commitment Therapy for Adolescents and Young Adults With Sickle Cell Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age14-21
SponsorChildren's Hospital Los Angeles
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
ACT for SCD
BehavioralPhase 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.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Acceptance Commitment TherapyExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
12 weeks2
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.
Time frame
6 mos3
SCD Health-Related Internalized Stigma Scale
an 11-item tool assessing internalized stigma and other factors in sickle cell disease (SCD) patients
Time frame
6 mos4
Transition Readiness Assessment Questionnaire (TRAQ),
measure acquisition of transition readiness skills across the five stages of change
Time frame
6 mosSecondary outcomes
1
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.
Time frame
12 weeks2
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.
Time frame
12 weeks3
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.
Time frame
12 weeks4
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.
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital Los Angeles
Lead sponsor
University of Southern California & Children's Hospital Los Angeles (USC-CHLA)
Collaborator
Source ClinicalTrials.gov