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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4-months post-intervention

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-months post-intervention

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Transition Readiness

Secondary outcome measures

Cognitive Assessment

Neuroimaging

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,588 Previous Clinical Trials

2,280,192 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals of less than 70 years old eligible for enrollment in this experiment?

"Based on the requirements for participation in this trial, only those between 10 and 18 years of age can enroll."

Answered by AI

Is it possible for me to join this research endeavor?

"This experiment seeks to recruit 120 minors, aged 10-18 and suffering from anemia or sickle cell disease. Furthermore, participants must have active follow-up care at Children's of Alabama Hospital and be proficient in English."

Answered by AI

Is this research project actively enlisting participants?

"Affirmative. Clinicaltrials.gov holds information that this clinical trial is currently seeking volunteers; the study was initially posted on July 1st 2022 and most recently refreshed on July 20th 2022. The research requires 120 participants from one location."

Answered by AI

What is the current estimated cohort of participants in this research?

"Affirmative. According to the information published on clinicaltrials.gov, this research endeavour is actively seeking participants since its initial post on July 1st 2022 and most recent update of July 20th 2022. For successful completion of the trial, 120 individuals must be recruited from a single site."

Answered by AI

What potential hazards exist with employing CREADY for people?

"Data collected from Phase 2 trials affirms CREADY's safety, thus earning it a score of 2. Unfortunately though, there is not enough evidence to support its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cognitive Remediation Intervention to Prepare for Transition of Care

Donna Murdaugh 2022. "Cognitive Remediation Intervention to Prepare for Transition of Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05336201.