Feasibility and Efficacy of a Home-based, Computerized Cognitive Training Program in Pediatric Sickle Cell Disease

NCT ID: NCT02857023

Last Updated: 2018-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2018-08-31

Brief Summary

Disease-related neurocognitive deficits are common in pediatric sickle cell disease (SCD). These deficits can significantly disrupt otherwise normal trajectories toward academic and vocational achievement and negatively impact psychosocial outcomes. Despite widespread recognition of neurocognitive deficits, there are no treatments shown to maintain or recover functioning once a child with SCD endures neuronal damage. Cognitive training (CT) has been a standard intervention used to stabilize and recover functioning in individuals with accidental or disease-related brain injury. Recent advances in technology have led to the development of computerized CT programs. This study seeks to assess the feasibility and efficacy of using computerized CT with pediatric patients with SCD. Children and adolescents with SCD between the ages of 7 and 16 years old (n = 80) will be recruited to complete a randomized (intervention or waitlist-control) home-based computerized CT program (Cogmed). Feasibility will be assessed by examining participation, retention, and program completion rates, as well as feedback from a feasibility and acceptability questionnaire and a brief qualitative interview. Participants will also complete assessments of attention, working memory, and academic fluency at baseline and immediately following the intervention. A final assessment will be conducted 6 months after the conclusion of the intervention to evaluate the stability of treatment effects.

Conditions

Anemia, Sickle Cell

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cogmed intervention

Cogmed RM Children and adolescents with SCD between the ages of 7 and 16 years old (n = 80) will be recruited to complete a randomized (intervention or waitlist-control) home-based computerized CT program (Cogmed)

Group Type: EXPERIMENTAL

Cogmed RM

Intervention Type: BEHAVIORAL

Cogmed consists of 12 increasingly challenging exercises (completed over 25 sessions spanning 5-8 weeks) that target skills involving visuo-spatial and verbal working memory.

Cogmed-waitlist control

Cogmed RM Children and adolescents with SCD between the ages of 7 and 16 years old (n = 80) will be recruited to complete a randomized (intervention or waitlist-control) home-based computerized CT program (Cogmed)

Group Type: EXPERIMENTAL

Cogmed RM

Intervention Type: BEHAVIORAL

Cogmed consists of 12 increasingly challenging exercises (completed over 25 sessions spanning 5-8 weeks) that target skills involving visuo-spatial and verbal working memory.

Interventions

Cogmed RM

Cogmed consists of 12 increasingly challenging exercises (completed over 25 sessions spanning 5-8 weeks) that target skills involving visuo-spatial and verbal working memory.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosed with sickle cell disease (HbSS, HbSC, or HbS-beta thalassemia).
• 7 to 16 years old.
• An absolute or relative working memory deficit.
• IQ of 70 or greater, as measured via the WISC-V.
• Presence of a caregiver who is willing and capable of providing consistent support and supervision during Cogmed training.

Exclusion Criteria

• Visual, motor, or auditory impairment that prevents computer use.
• Insufficient English fluency.
• Started taking or adjusted dose of medication to treat symptoms of ADHD in the last 30 days.
• Unreliable access to a source of electricity to charge an iPad battery.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steven J. Hardy

OTHER

Sponsor Role: lead

Responsible Party

Steven J. Hardy

Assistant Professor of Pediatrics and Psychiatry & Behavioral Sciences

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Steven Hardy, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Locations

Children's National Health System

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

2013141

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00004421

Identifier Type: -

Identifier Source: org_study_id