Training Attentional Awareness and Control in ADHD

NCT02489279 | Completed Results

• 2 other identifiers: TNI-SAC-IR43MH101924
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention deficit hyperactivity disorder.; Attention training; Mobile devices; Brain training

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Conners Continuous Performance Test (CPT) RT Variability Scaled Score

  Change was calculated as the score after 10 weeks of treatment minus the pre-treatment score at Baseline. This is a computerized continuous performance task yielding a measure of reaction time (RT) variability over the duration of the task as an assessment of sustained attention control. Less variability in RT is a sign of better sustained attention control. The scaled scores are T Scores and the range is 0-100. Smaller values represent better performance (i.e. lower variability). Consequently, a negative difference value (Post-Pre) indicates improvement. This measure directly addresses the training target, inconsistent control of sustained attention (the variability in RT over time), and is highly correlated with ADHD.

  Baseline and 10 weeks

• Change From Baseline in Nelson-Denny Reading Test - Comprehension Score

  Change was calculated as the score after 10 weeks of treatment minus the pre-treatment score at Baseline. The Nelson Denny Reading Comprehension test is a time-limited (20-minute) measure of an important daily life activity that is impaired in ADHD, and impacted by poor sustained attention. The score range is from 0-76 with larger values representing better performance. A larger positive difference value (Post- Pre) indicates an improvement in reading comprehension.

  Baseline and 10 weeks

Secondary Outcomes (2)

• Change From Baseline in Adult Attention-Deficit Hyperactivity Disorder Self-Report Scale (ASRS) - Inattentive Subscale

  Baseline and 10 weeks

• Change From Baseline in Adult Attention-Deficit Hyperactivity Disorder Self-Report Scale (ASRS) - Hyperactive Subscale

  Baseline and 10 weeks

Study Arms (2)

Active - SAC

EXPERIMENTAL

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

Behavioral: Sustained Attention Control (SAC) Method

Control - Scrabble

ACTIVE COMPARATOR

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

Behavioral: Scrabble

Interventions

Sustained Attention Control (SAC) Method BEHAVIORAL

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

Active - SAC

Scrabble BEHAVIORAL

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

Control - Scrabble

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Clinical Global Impression-Severity (CGI-S) score ≥ 4 for ADHD
• 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)
• Able in the opinion of the investigator to complete all required study procedures.

You may not qualify if:

• History of diagnosis of childhood disorder other than ADHD (e.g. autism, dyslexia)
• 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
• History of seizure disorder, brain tumor, other major neurological disorder or head injury resulting in loss of consciousness
• Serious oxygen deprivation
• Current psychopathology requiring ongoing treatment with antipsychotic medications, mood stabilizers, benzodiazepines, or anticonvulsants
• Current untreated psychopathology which is rated to be primary in terms of severity (greater than ADHD severity)
• Current treatment with guanfacine.

Sponsors & Collaborators

• Think Now Incorporated: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UCLA Semel Institute

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

M Phase Cell Cycle Checkpoints; Methods

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cell Cycle Checkpoints; Cell Cycle; Cell Physiological Phenomena; Mitosis; Cell Nucleus Division; Cell Division; Genetic Phenomena; Investigative Techniques

Results Point of Contact

• Title: Dr. Gregory V. Simpson
• Organization: Think Now, Inc.

greg@think-now.com

4156016522

Study Officials

• Mark S Cohen, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Founder and Chief Scientific Officer

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 3, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: April 1, 2017
• Last Updated: July 10, 2019
• Results First Posted: July 10, 2019

Record last verified: 2019-06

Locations

US (1)