Clinical trial NCT03213613: Double-Blind Randomized Controlled Trial for the Evaluation of a Novel Adaptive Attention Training in Healthy Adolescents
Official title: Double-Blind Randomized Controlled Trial for the Evaluation of a Novel Adaptive Attention Training in Healthy Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adolescents
Keywords: Teen health
Teen development
Adolescent development
Memory
Attention
Reward processing
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Alliance for Decision Education
First posted: 2017-07-11
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Test of Variables of Attention (TOVA), visual form, change from baseline
timeFrame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
Secondary outcomes:
measure: Delay Discounting task, change from baseline
timeFrame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
Other outcomes:
measure: Filter task, change from baseline
timeFrame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
measure: Attend Ignore Distractor (AID) task, change from baseline
timeFrame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
measure: Adaptive Cognitive Evaluation (ACE) neuropsychological battery, change from baseline
timeFrame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
measure: EEG-based neural processing of stimuli in Test of Variables of Attention (TOVA), visual form, change from baseline
timeFrame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
measure: fMRI-based blood oxygen level dependent (BOLD) signal processing during Delay Discounting task, change from baseline
timeFrame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
measure: EEG-based neural processing of stimuli in Filter task, change from baseline
timeFrame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
measure: EEG-based neural processing of stimuli in Attend Ignore Distractor (AID) task, change from baseline
timeFrame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
measure: Resting-state functional connectivity (functional MRI and EEG), change from baseline
timeFrame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
measure: Structural connectivity (diffusion tensor imaging, DTI), change from baseline
timeFrame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
measure: Mindful Attention Awareness Scale (MAAS), change from baseline
timeFrame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
measure: Warwick-Edinburgh Mental Wellbeing-Scale, change from baseline
timeFrame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
measure: Torrance Tests of Creative Thinking, change from baseline
timeFrame: Change from baseline at completion of practice on assigned intervention.
measure: Child Self-Control Rating Scale (parent and teacher ratings), change from baseline
timeFrame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
measure: SEA battery, change from baseline
timeFrame: Change from baseline at completion of practice on assigned intervention and at 6 months follow-up post-intervention.
Locations:
city: San Francisco
country: United States
facility: UCSF Neuroscape
state: California
Study officials:
affiliation: University of California, San Francisco
name: Courtney Gallen, PhD
role: PRINCIPAL_INVESTIGATOR
References: