Training Attentional Awareness and Control in ADHD

NCT ID: NCT02489279

Last Updated: 2019-07-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-04-30

Brief Summary

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The purpose of this study is to evaluate the effects of different types of cognitive training on attention in adults with Attention Deficit Hyperactivity Disorder (ADHD) using mobile software on personal mobile devices.

Detailed Description

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Different types of software-based cognitive training are thought to impact attention via different mechanisms. This study examines the nature of the effects on sustained attention of two different types of mobile software based training. Because the nature of the training method is behavioral, the investigators can not divulge the differences in the training methods and their hypothesized differences in their impact on attention.

Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active - SAC

Behavioral learning by using the Sustained Attention Control (SAC) Method's mobile software to increase sustained attention skills and self-awareness of attention control.

Group Type EXPERIMENTAL

Sustained Attention Control (SAC) Method

Intervention Type BEHAVIORAL

Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks.

Control - Scrabble

Behavioral learning using the mobile software game "Scrabble" to exercise word processing and executive control functions.

Group Type ACTIVE_COMPARATOR

Scrabble

Intervention Type BEHAVIORAL

Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks.

Interventions

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Sustained Attention Control (SAC) Method

Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks.

Intervention Type BEHAVIORAL

Scrabble

Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Meet established Diagnostic and Statistical Manual-5 (DSM-5) criteria for ADHD predominately inattentive or combined subtype with clinically significant levels of impairment, diagnosed by structured clinical interview, the Mini International Neuropsychiatric Interview, and corroborating information
2. Clinical Global Impression-Severity (CGI-S) score ≥ 4 for ADHD
3. No lifetime history of DSM-5 bipolar disorder, psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, substance abuse, or substance dependence (except nicotine) as assessed with the Mini-International Neuropsychiatric Interview (MINI)
4. Able in the opinion of the investigator to complete all required study procedures.

Exclusion Criteria

1. History of diagnosis of childhood disorder other than ADHD (e.g. autism, dyslexia)
2. History of any general medical condition likely to require chronic use of medication with identified Central Nervous System (CNS) effects suspected to alter cognitive performance
3. History of seizure disorder, brain tumor, other major neurological disorder or head injury resulting in loss of consciousness
4. Serious oxygen deprivation
5. Current psychopathology requiring ongoing treatment with antipsychotic medications, mood stabilizers, benzodiazepines, or anticonvulsants
6. Current untreated psychopathology which is rated to be primary in terms of severity (greater than ADHD severity)
7. Current treatment with guanfacine.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Think Now Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Gregory Simpson, Ph.D.

Founder and Chief Scientific Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark S Cohen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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UCLA Semel Institute

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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R43MH101924

Identifier Type: NIH

Identifier Source: secondary_id

View Link

TNI-SAC-I

Identifier Type: -

Identifier Source: org_study_id

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