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

May 4, 2023 updated by: University of California, San Francisco
This project will evaluate the neuro-cognitive outcomes of a novel, adaptive attention training in a healthy adolescent population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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.
Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Delay Discounting task, change from baseline
Time Frame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Filter task, change from baseline
Time Frame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
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
Time Frame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
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
Time Frame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
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
Time Frame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
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
Time Frame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
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
Time Frame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
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
Time Frame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
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
Time Frame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
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
Time Frame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
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
Time Frame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
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
Time Frame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
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
Time Frame: Change from baseline at completion of practice on assigned intervention.
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
Time Frame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
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
Time Frame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alliance for Decision Education

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Courtney Gallen, PhD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 13, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 13, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 13, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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