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

Not Applicable

Completed

• Conditions: Healthy Adolescents
• Interventions: Behavioral: Low-dose Adaptive Attention Training; Behavioral: Adaptive Attention Training; Behavioral: Active Control

• Registration Number: NCT03213613
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-07-07
• Study First Posted: 2017-07-11
• Study Start: 2019-06-13
• Primary Completion: 2022-12-13
• Study Completion: 2022-12-13
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-dose Adaptive Attention Training	Low-dose Adaptive Attention Training	The low-dose training group will engage in 1 hour of at-home training on 'Engage'. Individuals will complete two 30-minute sessions at the beginning and middle of a six-week period. Compliance will be monitored similarly to the adaptive attention training group.
Adaptive Attention Training	Adaptive Attention Training	The training group will engage in 15 hours of at-home training on a novel iPad-based adaptive attention training program ('Engage'). Individuals will complete thirty 30-minute sessions over six weeks. Training compliance and performance data (accuracies and reaction times) will be continuously monitored remotely and analyzed over secure online servers to ensure that participants are completing training as scheduled and to deal with any unexpected road-blocks in training.
Active Control	Active Control	The active control group will engage in 15 hours of at-home training on an iPad game ('Boing'). Individuals will complete game play for the same number of hours as the training group to control for the effects of computer exposure and interaction, contact with research personnel, and monetary rewards. Compliance will be monitored similarly to the adaptive attention training group.

Primary Outcome Measures

Name	Time	Method
Test of Variables of Attention (TOVA), visual form, change from baseline	Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.

Secondary Outcome Measures

Name	Time	Method
Delay Discounting task, change from baseline	Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.

Trial Locations

Locations (1)

UCSF Neuroscape; 🇺🇸 San Francisco, California, United States