Recruiting

Digital Cognitive Rehabilitation

Sponsor:

Children's National Research Institute

Code:

NCT06770010

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 7 - 16

Healthy Volunteers: Not accepted

Interventions

Cogmed+

Study Details

Brief summary:

This is a single site nonrandomized pilot clinical trial of the feasibility, acceptability, and efficacy of a combination treatment involving digital Cogmed working memory skills training, social support components, and memory strategy training to improve adherence to Cogmed in youth with sickle cell disease ages 7-16 years.

Conditions

Sickle Cell Disease

Study ID

NCT06770010

Start date

Mar 5, 2025

Status verified date

Feb, 2025

Completion date

Apr 1, 2026

Anticipated

Primary completion date

Feb 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 16

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Diagnosis of sickle cell disease (any genotype).
2. Between ages 7-16 years old.
3. Patients will only enter the treatment phase if they score >1 SD below the normative mean on at least one standardized working memory assessment (i.e., Digit Span or Spatial Span subtests) or demonstrate a relative weakness in working memory (>1 SD below the estimated IQ).

Exclusion Criteria:

1. Motor, visual, or auditory impairment that prevents computer use.
2. Diagnosis of a mental health condition that precludes, or takes treatment precedence over, participation in the cognitive training.
3. History of photosensitive seizures.
4. Insufficient English fluency.
5. Recent initiation or dose adjustment of a stimulant medication to treat attention problems (< 30 days).

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cogmed+

Home-based digital cognitive rehabilitation and memory strategy training targeting working memory functioning.

Interventions

Cogmed+

Cogmed is a home-based, digital working memory training program compatible with tablet devices. The program, designed for children ages 7 and older, consists of engaging cognitive exercises that target skills involving visuospatial and verbal working memory. An essential component of Cogmed training involves assignment of an intervention "coach" who has access to detailed data on the user's training data. Families will have videoconference meetings once per week with an intervention coach to review progress, provide feedback and answer any questions that arise during treatment. In addition, participants' coaching calls will be supplemented with direct instruction on the use of memory strategies. Social support interventions will also be provided involving three primary approaches: (1) multi-family Cogmed Kickoff social events; (2) social incentives; and (3) peer navigator support.

Primary outcome measure

  • Number of participants who complete Cogmed training [ Time Frame: Approximately 5-8 weeks after start of Cogmed training ]
  • Number of participants who attend a Cogmed Kickoff social event [ Time Frame: Within approximately 6 months of study enrollment ]
  • Number of participants who participate in memory strategy training [ Time Frame: Approximately 5-8 weeks after start of Cogmed training ]

Central Contacts and Locations

Central contacts

Steven Hardy, PhD

202-476-5000sjhardy@childrensnational.org

Sara Ropeta, BS

202-476-5000sropeta@childrensnational.org

Locations

Children's National Hospital

Recruiting

Washington, District of Columbia, United States, 20010

Contacts

Steven Hardy, PhD

202-476-5000sjhardy@childrensnational.org

Sara Ropeta, BS

202-476-5000sropeta@childrensnational.org

Principal Investigator:

Steven Hardy, PhD

More Information

Sponsor

Children's National Research Institute

Last update posted

Feb 13, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's National Research Institute on 2025-02-13.