Training Attentional Awareness and Control in ADHD (SAC-I)

Training Attentional Awareness and Control in Attention Deficit Hyperactivity Disorder (ADHD)

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Behavioral: Sustained Attention Control (SAC) Method; Behavioral: Scrabble

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Semel Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Sustained Attention Control (SAC) Method; Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks.
Active Comparator: Control - Scrabble; Behavioral learning using the mobile software game "Scrabble" to exercise word processing and executive control functions.	Behavioral: Scrabble; Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Adult Attention-Deficit Hyperactivity Disorder Self-Report Scale (ASRS) - Inattentive Subscale	Change was calculated as the score after 10 weeks of treatment minus the pre-treatment score at Baseline. The ASRS is a scale to evaluate ADHD symptoms in adults. The Inattentive Symptoms Subscale range = 0-36. Higher values are worse. Consequently, a negative difference value indicates improvement.	Baseline and 10 weeks
Change From Baseline in Adult Attention-Deficit Hyperactivity Disorder Self-Report Scale (ASRS) - Hyperactive Subscale	Change was calculated as the score after 10 weeks of treatment minus the pre-treatment score at Baseline. The ASRS is a scale to evaluate ADHD symptoms in adults. The Hyperactive Symptoms Subscale range = 0-36. Higher values are worse. Consequently, a negative difference value indicates improvement.	Baseline and 10 weeks

Collaborators and Investigators

• Sponsor: Think Now Incorporated
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Mark S Cohen, Ph.D., University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: June 30, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 3, 2015

Study Record Updates

• Last Update Posted (Actual): July 10, 2019
• Last Update Submitted That Met QC Criteria: June 19, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Attention deficit hyperactivity disorder.; Attention training; Mobile devices; Brain training
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: TNI-SAC-I; R43MH101924 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No