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

Anemia, Sickle Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02857023
• Other study ID #: Pro00004421
• Secondary ID: 2013141
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: August 2018

Study information

• Verified date: November 2018
• Source: Children's Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Children's National Health System	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Steven J. Hardy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Verbal working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Digit Span subtest	Cogmed efficacy will be evaluated by examining change in scaled scores on the WISC-V Digit Span subtest after completing Cogmed.	Baseline, 8-10 weeks, 6-month follow-up
Secondary	Visua-spatial working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Picture Span subtest	Cogmed efficacy will be evaluated by examining change in scaled scores on the WISC-V Picture Span subtest after completing Cogmed.	Baseline, 8-10 weeks, 6-month follow-up
Secondary	Visua-spatial working memory assessed by change in Wechsler Intelligence Scale for Children (WISC-V) Spatial Span subtest	Cogmed efficacy will be evaluated by examining change in scaled scores on the WISC-V Spatial Span subtest after completing Cogmed.	Baseline, 8-10 weeks, 6-month follow-up