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Clinical Trials/NCT03213613
NCT03213613
Completed
Not Applicable

Double-Blind Randomized Controlled Trial for the Evaluation of a Novel Adaptive Attention Training in Healthy Adolescents

University of California, San Francisco1 site in 1 country60 target enrollmentJune 13, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Adolescents
Sponsor
University of California, San Francisco
Enrollment
60
Locations
1
Primary Endpoint
Test of Variables of Attention (TOVA), visual form, change from baseline
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This project will evaluate the neuro-cognitive outcomes of a novel, adaptive attention training in a healthy adolescent population.

Detailed Description

Aspects of cognitive control, such as attention and working memory, are critical for successful goal-directed behavior. Importantly, variability in cognitive control abilities can influence real-world functioning, such as scholastic success in children and adolescents. The primary goal of this project is to examine the outcomes of a novel, adaptive attention training that primarily targets aspects of sustained attention and secondarily targets delayed gratification in adolescents. As such, the investigators will validate the feasibility and efficacy of this novel training in a randomized controlled trial (RCT) study. Specifically, healthy adolescents (age 12-16 years old) will be recruited for a longitudinal experiment in which they are randomly assigned to the adaptive attention training group ('Engage') or one of two expectancy-matched control groups. Depending on the assigned group, participants will complete 1 hour (low-dose control group) or 15 hours ('Engage' and active control groups) of training as well as pre-, post- and follow-up assessments of cognitive, neural, and behavioral measures. We hypothesize that completion of 'Engage' training will result in enhancement of fronto-parietal control functions that underlie sustained attention and suppression of ventral-striatal reward impulses, ultimately improving these abilities in a healthy adolescent population.

Registry
clinicaltrials.gov
Start Date
June 13, 2019
End Date
December 13, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Healthy right-handed children, age 12-16 years old
  • No ADHD status (verified with the Vanderbilt ADHD Parent form)
  • Willing and able to undergo MRI and EEG procedures

Exclusion Criteria

  • Current psychotropic medications
  • Current diagnosis of any axis I psychiatric disorder
  • History of seizure disorder or seizure episodes over the last 2 years
  • Motor/perceptual handicap that prevents computer use

Outcomes

Primary Outcomes

Test of Variables of Attention (TOVA), visual form, change from baseline

Time Frame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.

Secondary Outcomes

  • Delay Discounting task, change from baseline(Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.)

Study Sites (1)

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