Actively Recruiting
The Cognitive-Remediation of Executive and Adaptive Deficits in Youth (C-READY) Intervention: A Randomized Controlled Trial for Adolescents With Sickle Cell Disease to Prepare for Transition of Care
Led by University of Alabama at Birmingham · Updated on 2026-02-27
120
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of a telehealth version of the Cognitive-Remediation of Executive and Adaptive Deficits in Youth (C-READY) intervention for adolescents with sickle cell disease (SCD). Cognitive impairment is common and affects over half of children with SCD, impacting their ability to make decisions needed for a successful transition to adult self-care. The study addresses challenges caused by cognitive difficulties and social health disparities in preparing youth for this transition. The study involves a manualized, individualized program delivered over 4 weeks through eight 60-minute one-on-one telehealth sessions between the adolescent and a trained therapist. Caregivers participate through weekly phone calls to support and encourage progress. Participants focus on building independence in skills like managing medications, pain, sleep, and daily health routines. The trial randomly assigns 120 youths aged 10 to 18 into two groups: one receives the intervention immediately, and the other waits 4 weeks before starting the same program. During the study, participants will be assessed on transition readiness skills and cognitive abilities, including brain imaging to evaluate changes in brain function. Measurements occur at 4 weeks and again 4 months after the intervention. The study aims to develop an accessible and scalable intervention to improve self-care and quality of life for youth with SCD. The total participation time varies by group and includes follow-up assessments to monitor progress and safety.
CONDITIONS
Brief Title
Cognitive Remediation Intervention to Prepare for Transition of Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of sickle cell disease (all genotypes)
- Active follow-up at Children's of Alabama Hospital
- Ages 10 to 18 years
- English-speaking
You will not qualify if you...
- History of seizures or overt stroke
- History of intellectual disability or autism spectrum disorder
- Inability to participate in MRI scan (e.g., metal implants, neurostimulators, claustrophobia)
- Currently on psychotropic medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - 4 weeks
Participants receive the C-READY cognitive remediation intervention consisting of 8 one-on-one telehealth sessions over 4 weeks focused on self-management and goal-setting skills to prepare for transition of care. Caregivers also participate in weekly phone sessions to support the intervention.
8 telehealth sessions and weekly phone calls during the intervention period
Duration - 4 months post-intervention
Participants are assessed for transition readiness, cognitive performance, and neuroimaging outcomes to evaluate the effects of the intervention.
1 to 2 visits for outcome assessments
Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
Research Team
D
Donna Murdaugh, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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