Training Attentional Awareness and Control in ADHD

Attention Deficit Hyperactivity Disorder Clinical Trial

— SAC-I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02489279
• Other study ID #: TNI-SAC-I
• Secondary ID: R43MH101924
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: April 2017

Study information

• Verified date: June 2019
• Source: Think Now Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: April 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Behavioral:
• Sustained Attention Control (SAC) Method
Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks.
• Scrabble
Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks.

Locations

Country	Name	City	State
United States	UCLA Semel Institute	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Think Now Incorporated	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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