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

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

Study Overview

• Status: Completed
• Conditions: Healthy Adolescents
• Intervention / Treatment: Behavioral: Adaptive Attention Training; Behavioral: Active Control; Behavioral: Low-dose Adaptive Attention Training

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • UCSF Neuroscape

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Adaptive Attention Training; The training is comprised of a time-based titration of rich audiovisual and sparse audio interactive environments. Training progressively transitions the participants from an immersive and rapid reward setting to a less immersive, sensory impoverished, and slower reward setting. Further, the participants' actions require delayed gratification decisions to accomplish play in the sparse setting, building fronto-parietal control through sustained attention and suppression of ventral-striatal reward impulses.
Placebo Comparator: 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.	Behavioral: Active Control; Participants in the expectancy-matched active control group will play a visuo-spatial iPad game, in which players use their finger to move an object to different successive square platforms. Expectancy matching to the adaptive attention training was pre-confirmed in 121 participants (18-20 years of age), using targeted surveys on MTurk about their expectations of either training exposure on our specific outcome measures. To balance expectations of potential benefits, this group will receive identical recruitment and experimental instructions as the adaptive attention training group.
Placebo Comparator: 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.	Behavioral: Low-dose Adaptive Attention Training; Participants in the low-dose training group will play a reduced number of sessions as the Adaptive Attention Training group. Specifically, they will train for two 30-minute sessions at the start and middle of a six-week period. To balance expectations of potential benefits, this group will receive identical recruitment and experimental instructions as the adaptive attention training group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Filter task, change from baseline	For assessment of visual working memory with distraction	Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
Attend Ignore Distractor (AID) task, change from baseline	For assessment of visual working memory with distraction during memory delay	Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
Adaptive Cognitive Evaluation (ACE) neuropsychological battery, change from baseline	For global assessment of cognitive control	Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
EEG-based neural processing of stimuli in Test of Variables of Attention (TOVA), visual form, change from baseline	For assessment of neural processing underlying sustained attention	Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
fMRI-based blood oxygen level dependent (BOLD) signal processing during Delay Discounting task, change from baseline	For assessment of neural processing underlying delay discounting	Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
EEG-based neural processing of stimuli in Filter task, change from baseline	For assessment of neural processing underlying visual working memory with distraction	Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
EEG-based neural processing of stimuli in Attend Ignore Distractor (AID) task, change from baseline	For assessment of neural processing underlying visual working memory, with distraction during memory delay	Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
Resting-state functional connectivity (functional MRI and EEG), change from baseline	For neural assessment of intrinsic functional connections between brain regions	Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
Structural connectivity (diffusion tensor imaging, DTI), change from baseline	For neural assessment of structural (white matter) connections between brain regions	Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
Mindful Attention Awareness Scale (MAAS), change from baseline	For behavioral assessment of mindful attention awareness	Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
Warwick-Edinburgh Mental Wellbeing-Scale, change from baseline	For behavioral assessment of mental wellbeing	Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
Torrance Tests of Creative Thinking, change from baseline	For assessment of visual creativity	Change from baseline at completion of practice on assigned intervention.
Child Self-Control Rating Scale (parent and teacher ratings), change from baseline	For behavioral assessment of self-control	Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
SEA battery, change from baseline	For assessment of math and reading skills	Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Alliance for Decision Education
• Investigators: Principal Investigator: Courtney Gallen, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2019
• Primary Completion (Actual): December 13, 2022
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: July 7, 2017
• First Submitted That Met QC Criteria: July 7, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Estimate): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Attention; Memory; Reward processing; Adolescent development; Teen health; Teen development
• Other Study ID Numbers: P0505751

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No