Training Attentional Awareness and Control in ADHD

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Behavioral: Scrabble; Behavioral: Sustained Attention Control (SAC) Method

• Registration Number: NCT02489279
• Lead Sponsor: Think Now Incorporated

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.

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 Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-30
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-03
• Primary Completion: 2016-12
• Study Completion: 2017-04
• Results First Submitted: 2019-04-29
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-19
• Last Update Submitted: 2019-06-19
• Results First Posted: 2019-07-10
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control - Scrabble	Scrabble	Behavioral learning using the mobile software game "Scrabble" to exercise word processing and executive control functions.
Active - SAC	Sustained Attention Control (SAC) Method	Behavioral learning by using the Sustained Attention Control (SAC) Method's mobile software to increase sustained attention skills and self-awareness of attention control.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Nelson-Denny Reading Test - Comprehension Score	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.
Change From Baseline in Conners Continuous Performance Test (CPT) RT Variability Scaled Score	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Adult Attention-Deficit Hyperactivity Disorder Self-Report Scale (ASRS) - Hyperactive Subscale	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.
Change From Baseline in Adult Attention-Deficit Hyperactivity Disorder Self-Report Scale (ASRS) - Inattentive Subscale	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.

Trial Locations

Locations (1)

UCLA Semel Institute; 🇺🇸 Los Angeles, California, United States