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

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Sickle Cell Disease; Self Efficacy; Coping Skills; Health-Related Behavior; Adolescent Behavior
• Intervention / Treatment: Behavioral: CREADY (Cognitive-Remediation of Executive and Adaptive Deficits in Youth)

Detailed Description

Cognitive impairment is a pervasive debilitating feature of sickle cell disease (SCD), with over 50% of children demonstrating early neurodevelopmental delays, ultimately influencing ability for adolescents with SCD to engage in effective decision-making needed for successful transition into adulthood. The negative effect of cognitive impairment on transition to adult self-care is further compounded by health-related disparities and poor social determinants of health. Transition to self-care among youth with SCD may be facilitated by cognitive remediation. One potential avenue to disseminate cognitive-based interventions to disadvantaged neighborhoods is through telehealth administration. This study will examine the efficacy of C-READY on adaptive and self-management skills in youth with SCD, where there is a critical need to enhance self-efficacy/self-care skills for successful transition into adulthood. Additionally, this study overcomes the barriers of transportation that preclude vulnerable patient populations from returning to the clinic for in-person interventions by offering the intervention in their homes via telehealth. C-READY is a manualized, individualized intervention delivered over the course of 4 weeks in 8, 60 minute one-on-one telehealth sessions between the youth and trained therapist. Caregiver involvement and accountability is promoted by weekly phone sessions in between the 8 primary sessions. The emphasis C-READY is on promotion of independence with adaptive skills necessary for transition of care to adult healthcare, such as managing medications, pain management, sleep hygiene, and/or daily health-related routines; the objective is to identify and focus on goals that best promote those skills. Thus, we will conduct a two-arm, wait-listed randomized control trial among 120 patients with SCD (ages 10-18 years), 60 participants per group; half randomized to the intervention arm, and half to the waitlist arm. The primary outcome is transition readiness skills, with secondary outcome measures of cognitive abilities and neuroimaging metrics. We hypothesize that youth with SCD who participate in C-READY will show improvement in transition readiness skills and show greater improvement in cognitive performance. We also hypothesize that participation in C-READY will improve functional brain connectivity and increase compensatory neural mechanisms. In sum, this study will be the first step in developing highly accessible and scalable evidence-based intervention to improve transition of care, enhance self-care, and ultimately improve overall quality of life in youth with SCD.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Donna Murdaugh, PhD; Phone Number: 2056382189; Email: donnamurdaugh@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Murdaugh; Phone Number: 2056382135

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: C-READY (Cognitive-Remediation of Executive and Adaptive Deficits in Youth); Self-management and goal-setting cognitive remediation	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.
Other: Wait-List Control Group; Will receive the same C-READY intervention after a 4-week wait period	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Assessment	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.	4-weeks
Cognitive Assessment	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.	4-months post-intervention
Neuroimaging	Brain scan (MRI) of structural and functional connectivity	4-weeks

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Genetic Diseases, Inborn; Neurocognitive Disorders; Hematologic Diseases; Cognition Disorders; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior; Hemic and Lymphatic Diseases; Cognitive Dysfunction; Anemia, Sickle Cell; Health Behavior; Adolescent Behavior
• Other Study ID Numbers: 300003655

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No