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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03213613
Enrollment
60
Registered
2017-07-11
Start date
2019-06-13
Completion date
2022-12-13
Last updated
2023-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adolescents

Keywords

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

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.

Interventions

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.

BEHAVIORALActive 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.

BEHAVIORALLow-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.

Sponsors

Alliance for Decision Education
CollaboratorUNKNOWN
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Test of Variables of Attention (TOVA), visual form, change from baselineChange from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.

Secondary

MeasureTime frame
Delay Discounting task, change from baselineChange from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.

Other

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026