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

NCT02857023 | Completed

• 2 other identifiers: Pro000044212013141
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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

Keywords

Neurocognitive; Working memory; Cogmed; Cognitive training

Outcome Measures

Primary Outcomes (1)

• Cogmed feasibility assessed by program completion rates

  Feasibility will be determined by examining the proportion of the sample that completes at least 20 Cogmed sessions (i.e., 80% of the program) within the allotted time frame (10-week maximum).

  Following completion of Cogmed (approximately 8-10 weeks from baseline)

Secondary Outcomes (3)

• Verbal working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Digit Span subtest

  Baseline, 8-10 weeks, 6-month follow-up

• Visua-spatial working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Picture Span subtest

  Baseline, 8-10 weeks, 6-month follow-up

• Visua-spatial working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Spatial Span subtest

  Baseline, 8-10 weeks, 6-month follow-up

Study Arms (2)

Cogmed intervention

EXPERIMENTAL

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)

Behavioral: Cogmed RM

Cogmed-waitlist control

EXPERIMENTAL

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)

Behavioral: Cogmed RM

Interventions

Cogmed RM 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 intervention; Cogmed-waitlist control

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosed with sickle cell disease (HbSS, HbSC, or HbS-beta thalassemia).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Steven J. Hardy: lead

Study Sites (1)

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Steven Hardy, PhD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics and Psychiatry & Behavioral Sciences

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 5, 2016
• Study Start: October 1, 2014
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: November 23, 2018

Record last verified: 2018-11

Locations

US (1)