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

NCT03213613 | Completed

• 1 other identifier: P0505751
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adolescents

Keywords

Teen health; Teen development; Adolescent development; Memory; Attention; Reward processing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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 Outcomes (14)

• Filter task, change from baseline

  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

  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

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

Study Arms (3)

Adaptive Attention Training

EXPERIMENTAL

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

Active Control

PLACEBO COMPARATOR

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

Low-dose Adaptive Attention Training

PLACEBO COMPARATOR

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

Interventions

Adaptive Attention Training BEHAVIORAL

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.

Adaptive Attention Training

Active Control BEHAVIORAL

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.

Active Control

Low-dose Adaptive Attention Training BEHAVIORAL

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.

Low-dose Adaptive Attention Training

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Alliance for Decision Education: collaborator

Study Sites (1)

UCSF Neuroscape

San Francisco, California, 94158, United States

Location

Study Officials

• Courtney Gallen, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 11, 2017
• Study Start: June 13, 2019
• Primary Completion: December 13, 2022
• Study Completion: December 13, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)