Double-Blind Randomized Controlled Trial for the Evaluation of a Novel Adaptive Attention Training in Healthy Adolescents
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ClinicalTrials.gov Identifier: NCT03213613 |
Recruitment Status :
Recruiting
First Posted : July 11, 2017
Last Update Posted : September 29, 2021
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Condition or disease | Intervention/treatment | Phase |
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Healthy Adolescents | Behavioral: Adaptive Attention Training Behavioral: Active Control Behavioral: Low-dose Adaptive Attention Training | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | Double-Blind Randomized Controlled Trial for the Evaluation of a Novel Adaptive Attention Training in Healthy Adolescents |
Actual Study Start Date : | June 13, 2019 |
Estimated Primary Completion Date : | October 1, 2022 |
Estimated Study Completion Date : | October 1, 2022 |
Arm | Intervention/treatment |
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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.
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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.
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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.
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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. |
- 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. ]
- 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. ]
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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

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Ages Eligible for Study: | 12 Years to 16 Years (Child) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213613
United States, California | |
UCSF Neuroscape | Recruiting |
San Francisco, California, United States, 94158 | |
Contact: Jessica Schachtner, BS 415-502-7321 NeuroscapeAttentionStudy@ucsf.edu | |
Principal Investigator: Courtney L Gallen, PhD | |
Principal Investigator: Jyoti Mishra, PhD | |
Principal Investigator: Adam Gazzaley, MD, PhD |
Principal Investigator: | Courtney Gallen, PhD | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT03213613 |
Other Study ID Numbers: |
P0505751 |
First Posted: | July 11, 2017 Key Record Dates |
Last Update Posted: | September 29, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Teen health Teen development Adolescent development |
Memory Attention Reward processing |