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Behavioral Intervention

Cognitive Remediation for Sickle Cell Disease

Phase 2
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of SCD (all genotypes)
Ages 10-18
Must not have
History of seizures or overt stroke
Currently on psychotropic medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-months post-intervention
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a telehealth version of an intervention designed to help adolescents with sickle cell disease manage their condition is effective.

Who is the study for?
This trial is for English-speaking adolescents aged 10-18 with any type of sickle cell disease (SCD), who are patients at Children's of Alabama Hospital. It excludes those with a history of seizures, stroke, intellectual disabilities or autism, metal implants that prevent MRI scans, severe claustrophobia, or current use of psychotropic medications.
What is being tested?
The study tests the CREADY program delivered via telehealth to help teens with SCD transition their healthcare management from pediatric to adult services. This randomized controlled trial assigns participants by chance to either receive this intervention or not.
What are the potential side effects?
Since CREADY is a cognitive-behavioral intervention and not a medication, it may have minimal physical side effects. However, some participants might experience stress or anxiety during the process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with sickle cell disease.
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I am between 10 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had seizures or a stroke.
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I am taking medication for my mental health.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-months post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-months post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Transition Readiness
Secondary study objectives
Cognitive Assessment
Neuroimaging

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Wait-List Control GroupExperimental Treatment1 Intervention
Will receive the same C-READY intervention after a 4-week wait period
Group II: C-READY (Cognitive-Remediation of Executive and Adaptive Deficits in Youth)Experimental Treatment1 Intervention
Self-management and goal-setting cognitive remediation

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,645 Previous Clinical Trials
2,342,732 Total Patients Enrolled

Media Library

CREADY (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05336201 — Phase 2
Sickle Cell Disease Research Study Groups: C-READY (Cognitive-Remediation of Executive and Adaptive Deficits in Youth), Wait-List Control Group
Sickle Cell Disease Clinical Trial 2023: CREADY Highlights & Side Effects. Trial Name: NCT05336201 — Phase 2
CREADY (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05336201 — Phase 2
~24 spots leftby Jun 2025
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