Cognitive Remediation Intervention to Prepare for Transition of Care
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
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2022
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2022
CompletedFirst Posted
Study publicly available on registry
April 20, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
February 27, 2026
February 1, 2026
4.3 years
April 13, 2022
February 25, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Transition Readiness
Questionnaire assessing how knowledgeable the youth is about their health condition and the skills necessary for self-management and self-advocacy
4-weeks
Transition Readiness
Questionnaire assessing how knowledgeable the youth is about their health condition and the skills necessary for self-management and self-advocacy
4-months post-intervention
Secondary Outcomes (3)
Cognitive Assessment
4-weeks
Cognitive Assessment
4-months post-intervention
Neuroimaging
4-weeks
Study Arms (2)
C-READY (Cognitive-Remediation of Executive and Adaptive Deficits in Youth)
EXPERIMENTALSelf-management and goal-setting cognitive remediation
Wait-List Control Group
OTHERWill receive the same C-READY intervention after a 4-week wait period
Interventions
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.
Eligibility Criteria
You may qualify if:
- Diagnosis of SCD (all genotypes)
- Active follow-up at Children's of Alabama Hospital
- Ages 10-18
- English-speaking
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 13, 2022
First Posted
April 20, 2022
Study Start
July 1, 2022
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
Sharing of the data generated by this project is an essential part of our proposed activities and will be carried out in several different ways. We will also make our results available to other scientists interested in understanding cognitive outcomes in youth with sickle cell disease, and to avoid unintentional duplication of research. We also hope that the results of this study will lead to future collaboration to further develop approaches to improve transition of care outcomes in adolescents and youth adults with sickle cell disease. Our plan includes presentation at national and international meetings and publications in peer-reviewed medical journals. All publications of these data will contain a statement of data sharing so that other researchers will know of its availability.