COMPLETED

Intervention Utilizing a Computerized Cognitive Rehabilitation Program (D-kit/EF1)

Conditions

Mild Intellectual Disability Borderline Intellectual Functioning

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this exploratory clinical trial is to test the effects of the computerized cognitive rehabilitation program (D-kit/EF1) for children with borderline intellectual functioning or mild intellectual disability after its use. Participants will use the D-kit/EF1 program on an iOS device 5 times a week for 30 minutes each session, for a duration of 12 weeks. Researchers will compare treatment group that uses D-kit/EF1 with sham group that watches educational videos on the same iOS device.

Official Title

A Randomized, Double-blind, Parallel-group, Exploratory Clinical Trial to Evaluate Executive Function and Cognitive Improvement After Intervention Utilizing a Computerized Cognitive Rehabilitation Program (D-kit/EF1) in Children With Borderline Intellectual Functioning or Mild Intellectual Disability (FSIQ 50 - 85)

Quick Facts

Study Start:2023-08-09

Study Completion:2024-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05933005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years to 8 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. Children aged 4-8 years (48-96 months) of both genders at the time of obtaining consent. 2. Children with borderline intellectual functioning or mild intellectual disability (FSIQ 50-85) who meet the following criteria within 3 months of screening: * Stanford-Binet Intelligence Scale - 5th edition (SB-5) criteria: FSIQ 50-85. * NIH Toolbox Cognition Battery (NIHTB-CB) DCCS score of 7 or lower. 3. Children who are capable of communicating and behaving at a level sufficient to participate in the required tests and therapeutic activities of this clinical trial. 4. Individuals for whom the legal guardian and primary caregiver have voluntarily decided to participate in this clinical trial after receiving sufficient explanation and have provided written consent to comply with the requirements of the clinical trial.	1. If the parents or primary caregiver of the trial subjects, who will perform the key assessments on the trial subjects, are unable to read or write in English, thus are impossible to conduct the assessments. 2. Patients with conditions (e.g., blindness, color blindness, hearing loss, or deafness) that make it difficult to perform the digital therapy of the medical device for the clinical trial, D-kit/EF1, and the key assessment item for the clinical trial, NIHTB-CB DCCS test. 3. If the subject has participated in another clinical trial or has been administered investigational drugs for clinical trial purposes within the 4 weeks prior to screening (except, cases where the subject has not received investigational drugs or has participated in non-interventional observational studies are eligible for enrollment). 4. Other subjects who are deemed unsuitable for participation in this clinical trial based on the judgment of the investigators.

Inclusion Criteria

Exclusion Criteria

1. Children aged 4-8 years (48-96 months) of both genders at the time of obtaining consent.
2. Children with borderline intellectual functioning or mild intellectual disability (FSIQ 50-85) who meet the following criteria within 3 months of screening:
* Stanford-Binet Intelligence Scale - 5th edition (SB-5) criteria: FSIQ 50-85.
* NIH Toolbox Cognition Battery (NIHTB-CB) DCCS score of 7 or lower.
3. Children who are capable of communicating and behaving at a level sufficient to participate in the required tests and therapeutic activities of this clinical trial.
4. Individuals for whom the legal guardian and primary caregiver have voluntarily decided to participate in this clinical trial after receiving sufficient explanation and have provided written consent to comply with the requirements of the clinical trial.

1. If the parents or primary caregiver of the trial subjects, who will perform the key assessments on the trial subjects, are unable to read or write in English, thus are impossible to conduct the assessments.
2. Patients with conditions (e.g., blindness, color blindness, hearing loss, or deafness) that make it difficult to perform the digital therapy of the medical device for the clinical trial, D-kit/EF1, and the key assessment item for the clinical trial, NIHTB-CB DCCS test.
3. If the subject has participated in another clinical trial or has been administered investigational drugs for clinical trial purposes within the 4 weeks prior to screening (except, cases where the subject has not received investigational drugs or has participated in non-interventional observational studies are eligible for enrollment).
4. Other subjects who are deemed unsuitable for participation in this clinical trial based on the judgment of the investigators.

Contacts and Locations

Principal Investigator

Young Shin Kim, MD PhD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

UCSF Nancy Friend Pritzker Psychiatry Building

San Francisco, California, 94107

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

Young Shin Kim, MD PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-09

Study Completion Date2024-05-01

Study Record Updates

Study Start Date2023-08-09

Study Completion Date2024-05-01

Terms related to this study

Additional Relevant MeSH Terms

Mild Intellectual Disability
Borderline Intellectual Functioning