Cognitive Remediation Intervention to Prepare for Transition of Care

NCT ID: NCT05336201

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2027-06-30

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.

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.

Conditions

Sickle Cell Disease; Cognitive Impairment; Adolescent Behavior; Self Efficacy; Health-Related Behavior; Coping Skills

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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

Self-management and goal-setting cognitive remediation

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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

Group Type: OTHER

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

Intervention Type: BEHAVIORAL

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.

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Donna Murdaugh

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Donna Murdaugh, PhD

Role: CONTACT

donnamurdaugh@uabmc.edu

2056382189

Facility Contacts

Murdaugh

Role: primary

2056382135

Other Identifiers

300003655

Identifier Type: -

Identifier Source: org_study_id