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Completed

NCT Number: NCT02489279

Training Attentional Awareness and Control in 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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Semel Institute

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Sustained Attention Control (SAC) Method

Behavioral

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

Scrabble

Behavioral

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

Primary outcomes

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

    Time frame: Baseline and 10 weeks

    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.

  2. Change From Baseline in Nelson-Denny Reading Test - Comprehension Score

    Time frame: Baseline and 10 weeks

    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.

Secondary outcomes

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

    Time frame: Baseline and 10 weeks

    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.

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

    Time frame: Baseline and 10 weeks

    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.

Sponsors and collaborators

Lead sponsor

Think Now Incorporated

Industry

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: SAC-I

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jul 3, 2015
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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