Cognitive Remediation Intervention to Prepare for Transition of Care

Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05336201
• Other study ID #: 300003655
• Status: Recruiting
• Phase: Phase 2
• Start date: July 1, 2022
• Est. completion date: June 30, 2027

Study information

• Verified date: July 2023
• Source: University of Alabama at Birmingham
• Contact: Donna Murdaugh, PhD
• Phone: 2056382189
• Email: donnamurdaugh[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Anemia, Sickle Cell
• Cognitive Impairment
• Coping Skills
• Self Efficacy
• Sickle Cell Disease

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Neuroimaging	Brain scan (MRI) of structural and functional connectivity	4-weeks