Recruiting
Phase 2

Cognitive Remediation

Sponsor:

University of Alabama at Birmingham

Code:

NCT05336201

Conditions

Sickle Cell Disease

Cognitive Impairment

Adolescent Behavior

Self Efficacy

Health-Related Behavior

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Interventions

CREADY (Cognitive-Remediation of Executive and Adaptive Deficits in Youth)

Study Details

Brief summary:

Randomized Controlled Trial (RTC) testing the efficacy of a telehealth adaptation of the Cognitive-Remediation of Executive and Adaptive Deficits in Youth (C-READY) intervention to prepare adolescents with sickle cell disease for transition of care.

Conditions

Sickle Cell Disease

Cognitive Impairment

Adolescent Behavior

Self Efficacy

Health-Related Behavior

Study ID

NCT05336201

Start date

Jul 1, 2022

Status verified date

Feb, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of SCD (all genotypes)
  • Active follow-up at Children's of Alabama Hospital
  • Ages 10-18
  • English-speaking

Exclusion Criteria:

  • History of seizures or overt stroke
  • History of Intellectual Disability or Autism Spectrum Disorder
  • Inability to participate in the MRI scan, such as metal implants, neurostimulators, claustrophobia
  • Currently on psychotropic medications

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: C-READY (Cognitive-Remediation of Executive and Adaptive Deficits in Youth)

Self-management and goal-setting cognitive remediation

other: Wait-List Control Group

Will receive the same C-READY intervention after a 4-week wait period

Interventions

CREADY (Cognitive-Remediation of Executive and Adaptive Deficits in Youth)

Manualized cognitive remediation intervention that includes 1) skills-based remediation (metacognitive training), 2) parent training, and 3) cognitive behavioral approaches. Intervention targets self-management and goal-setting skill building to promote independence in activities necessary for transition of care.

Primary outcome measure

  • Transition Readiness [ Time Frame: 4-weeks ]
  • Transition Readiness [ Time Frame: 4-months post-intervention ]

Central Contacts and Locations

Central contacts

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Murdaugh

2056382135

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-02-27.