Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT05528939

Recruiting

FAACTS: Feasibility/Acceptability of Attentional-Control Training in Survivors

Interventional

Phase not listed

Children's National Hospital

Sponsor: Children's National Research Institute

Last Updated: January 10, 2025

Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

This is a multicenter pilot randomized controlled trial, with an active control condition, of the feasibility, acceptability, and preliminary efficacy of EndeavorRx in a cohort of survivors of acute lymphoblastic leukemia or brain tumor ages 8-16 who are > 1 year from the end of therapy.

Show Detailed Description

Treatment Category

Device, Other

Required Mutations

None

Trial Started

June 14, 2023

Last Updated by Sponsor

January 10, 2025

Estimated Completion

August 31, 2025

Contact Study

Name:Steven Hardy, Ph.D.

Email:sjhardy@childrensnational.org

Phone:202-476-5000

Eligibility

Inclusion Criteria

* Aged 8-16 years at time of screening.

* History of diagnosis of acute lymphoblastic leukemia (ALL) or brain tumor (BT).

* At least 1 year from completion of planned therapy and stable from a disease standpoint.

* Participating child and caregiver are fluent in spoken English.

* Availability of a caregiver who is willing and capable of providing support and supervision during cognitive training.

* Participating child is either not taking any prescribed stimulant medication for attention difficulties or has been prescribed a stable dose of stimulant medication for attention difficulties for at least 30 days prior to enrollment.

* Only patients with a T-score ≥ 75th percentile on the CPT-3 Omission Errors scale or on the BRIEF-2 Cognitive Regulation Index will be randomized.

Exclusion Criteria

* A history of photosensitive seizures.

* A motor, visual, or auditory handicap that prevents computer use.

* A mental health condition that precludes, or takes treatment precedence over, participation in the cognitive training.

* Participants identified during the baseline assessment as having a full-scale IQ < 80, as estimated by WASI-II (Vocabulary and Matrix Reasoning), will not be randomized.

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Design Details

AllocationRandomized

Intervention ModelParallel Assignment

MaskingSingle

Number to Enroll50

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: Children will be asked to begin digital attentional control training at home within 6 weeks of baseline testing and to complete 6 training missions per day (25-30 minutes), 5 days per week, for 4 weeks (total = 120 training missions).

Interventions:

EndeavorRx
Control video game

Outcome Measures

Primary Outcome Measures

Feasibility assessed by patient/family interestBaseline

Feasibility will be determined by examining the proportion of eligible patients/families approached about the study who enroll

Feasibility assessed by EndeavorRx training adherence ratesAfter completion of 4 weeks of EndeavorRx training

Participants will be asked to complete 6 EndeavorRx training missions per day, 5 days per week, for 4 weeks, resulting in a possible training of 120 missions. Feasibility will be evaluated by examining the proportion of the sample that completes at least 60 EndeavorRx missions (50%).

Feasibility assessed by reports of technical ease-of-use and satisfactionEnd of training (+4 weeks)

Children and caregivers will be asked, "How easy or difficult was it to access (e.g., turn on device, start the program, use the program)" using a 5-point Likert scale (5 = "Very Easy"). Families will also be asked, "How satisfied or unsatisfied are you with your experience using EndeavorRx?" using a 5-point Likert scale (5 = "Very Satisfied").

Secondary Outcome Measures

Change from baseline inattention assessed by Omission Errors on the Conners' Continuous Performance Test, 3rd Edition (CPT-3) at end of trainingBaseline and end of training (+4 weeks)

The Conners CPT-3 is a standardized computer-administered assessment that uses T scores (M=50, SD=10) where higher scores indicate greater attention problems

Change from baseline inattention assessed by Omission Errors on the Conners' Continuous Performance Test, 3rd Edition (CPT-3) at 4-month follow-up (16 weeks post-training/control +/- 4 weeks)Baseline and 4 months after end of training (16 weeks post-training/control +/- 4 weeks)

The Conners CPT-3 is a standardized computer-administered assessment that uses T scores (M=50, SD=10) where higher scores indicate greater attention problems

Change from baseline inattention assessed by the ADHD Rating Scale, Fifth Edition (ADHD-RS-5) Inattention subscale at end of trainingBaseline and end of training (+4 weeks)

The ADHD-RS-5 is a caregiver-reported questionnaire measure of attentional symptoms based on DSM-5 criteria where higher raw scores indicate greater attention problems

Change from baseline inattention assessed by the ADHD Rating Scale, Fifth Edition (ADHD-RS-5) Inattention subscale at 4-month follow-up (16 weeks post-training/control +/- 4 weeks)Baseline and 4 months after end of training (16 weeks post-training/control +/- 4 weeks)

The ADHD-RS-5 is a caregiver-reported questionnaire measure of attentional symptoms based on DSM-5 criteria where higher raw scores indicate greater attention problems

Change from baseline inhibitory control assessed by the Behavior Rating Inventory of Executive Functioning, Second Edition (BRIEF-2) Inhibit subscale at end of trainingBaseline and end of training (+4 weeks)

The BRIEF-2 is a caregiver-reported questionnaire measure of executive functioning that uses T scores (M=50, SD=10) where higher scores indicate greater problems with executive functioning

Change from baseline inhibitory control assessed by the Behavior Rating Inventory of Executive Functioning, Second Edition (BRIEF-2) Inhibit subscale at 4-month follow-up (16 weeks post-training/control +/- 4 weeks)Baseline and 4 months after end of training (16 weeks post-training/control +/- 4 weeks)

The BRIEF-2 is a caregiver-reported questionnaire measure of executive functioning that uses T scores (M=50, SD=10) where higher scores indicate greater problems with executive functioning

Change from baseline executive functioning assessed by the Behavior Rating Inventory of Executive Functioning, Second Edition (BRIEF-2) Cognitive Regulation Index (CRI) at end of trainingBaseline and end of training (+4 weeks)

The BRIEF-2 is a caregiver-reported questionnaire measure of executive functioning that uses T scores (M=50, SD=10) where higher scores indicate greater problems with executive functioning

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Trial Sites

This study has 1 trial site

Children's National Hospital

Washington D.C., District of Columbia, US

Name:Steven Hardy, PhD

Recruiting

Washington D.C., District of Columbia, 20010 US

Children's National Hospital

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