Cognitive Remediation Intervention to Prepare for Transition of Care
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ClinicalTrials.gov Identifier: NCT05336201 |
Recruitment Status :
Recruiting
First Posted : April 20, 2022
Last Update Posted : July 25, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sickle Cell Disease Cognitive Impairment Adolescent Behavior Self Efficacy Health-Related Behavior Coping Skills | Behavioral: CREADY (Cognitive-Remediation of Executive and Adaptive Deficits in Youth) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Supportive Care |
Official Title: | 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 |
Actual Study Start Date : | July 1, 2022 |
Estimated Primary Completion Date : | June 30, 2024 |
Estimated Study Completion Date : | June 30, 2027 |

Arm | Intervention/treatment |
---|---|
Experimental: C-READY (Cognitive-Remediation of Executive and Adaptive Deficits in Youth)
Self-management and goal-setting cognitive remediation
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Behavioral: 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. |
Wait-List Control Group
Will receive the same C-READY intervention after a 4-week wait period
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Behavioral: 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. |
- Transition Readiness [ Time Frame: 4-weeks ]Questionnaire assessing how knowledgeable the youth is about their health condition and the skills necessary for self-management and self-advocacy
- Transition Readiness [ Time Frame: 4-months post-intervention ]Questionnaire assessing how knowledgeable the youth is about their health condition and the skills necessary for self-management and self-advocacy
- Cognitive Assessment [ Time Frame: 4-weeks ]A global cognitive deficit score will be calculated that assesses intellectual functioning, working memory, processing speed, attention, language, and executive functioning. The global cognitive deficit score is calculated as an average of test scores and normalized to a scale of 0-5, with 0 indicating normal functioning and 5 indicating severe deficits.
- Cognitive Assessment [ Time Frame: 4-months post-intervention ]A global cognitive deficit score will be calculated that assesses intellectual functioning, working memory, processing speed, attention, language, and executive functioning. The global cognitive deficit score is calculated as an average of test scores and normalized to a scale of 0-5, with 0 indicating normal functioning and 5 indicating severe deficits.
- Neuroimaging [ Time Frame: 4-weeks ]Brain scan (MRI) of structural and functional connectivity

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Ages Eligible for Study: | 10 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05336201
Contact: Donna Murdaugh, PhD | 2056382189 | donnamurdaugh@uabmc.edu |
United States, Alabama | |
University of Alabama at Birmingham | Recruiting |
Birmingham, Alabama, United States, 35233 | |
Contact: Murdaugh 205-638-2135 |
Responsible Party: | Donna Murdaugh, Assistant Professor, University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT05336201 |
Other Study ID Numbers: |
300003655 |
First Posted: | April 20, 2022 Key Record Dates |
Last Update Posted: | July 25, 2022 |
Last Verified: | July 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | 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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia |
Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |