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

Healthy Adolescents Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03213613
• Other study ID #: P0505751
• Status: Completed
• Phase: N/A
• Start date: June 13, 2019
• Est. completion date: December 13, 2022

Study information

• Verified date: May 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 13, 2022
• Est. primary completion date: December 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adolescents

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	UCSF Neuroscape	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Alliance for Decision Education

Country where clinical trial is conducted

United States, 

Outcome

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