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

Think Now Incorporated

Status: Completed

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Behavioral: Scrabble; Behavioral: Sustained Attention Control (SAC) Method

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT02489279

R43MH101924 (U.S. NIH Grant/Contract)

TNI-SAC-I

Details and patient eligibility

About

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.

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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107 participants in 2 patient groups

Active - SAC

Experimental group

Description:

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

Treatment:

Behavioral: Sustained Attention Control (SAC) Method

Control - Scrabble

Active Comparator group

Description:

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

Treatment:

Behavioral: Scrabble