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Completed

NCT Number: NCT03213613

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.

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Key information

Conditions

Healthy Adolescents

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Neuroscape

San Francisco, California, 94158, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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

  1. 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.

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Alliance for Decision Education

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 11, 2017
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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