NCT06770010 · Children's National Research Institute
Advancing Feasibility and Acceptability of Digital Cognitive Rehabilitation in Sickle Cell Disease
(ALL IN)
What this study is about
This is a single site nonrandomized pilot clinical trial of the feasibility, acceptability, and effectiveness 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.
View original scientific description
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.
Interventions
BEHAVIORAL
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 measures
Number of participants who complete Cogmed training
Time frame: Approximately 5-8 weeks after start of Cogmed training
At least 75% of participants will complete 10 or more Cogmed training sessions.
Number of participants who attend a Cogmed Kickoff social event
Time frame: Within approximately 6 months of study enrollment
At least 75% of participants will attend a Cogmed Kickoff social event.
Number of participants who participate in memory strategy training
Time frame: Approximately 5-8 weeks after start of Cogmed training
At least 75% of participants will complete 2 or more memory strategy training sessions.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosis of sickle cell disease (any genotype).
- Between ages 7-16 years old.
- 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
- Motor, visual, or auditory impairment that prevents computer use.
- Diagnosis of a mental health condition that precludes, or takes treatment precedence over, participation in the cognitive training.
- History of photosensitive seizures.
- Insufficient English fluency.
- Recent initiation or dose adjustment of a stimulant medication to treat attention problems (\< 30 days).
Where
- Washington D.C., District of Columbia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 13, 2025 · Source of record for eligibility and locations