The objective of this study is to assess the safety and effectiveness of an at-home, game-based digital therapy for treating adult patients with Attention-Deficit/Hyperactivity Disorder (ADHD).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
194
investigational game-play therapy
CNS Healthcare of Jacksonville
Jacksonville, Florida, United States
Accel Clinical Research Sites
Lakeland, Florida, United States
Rochester Center for Behavioral Medicine (RCBM)
Rochester Hills, Michigan, United States
Midwest Research Group
Brentwood, Missouri, United States
Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) Inattentive Symptoms subscale
The Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) has 66 items with multiple subscales.
Time frame: Study Day 0 to Study Day 63
Adult ADHD Self-Report Scale (ASRS) Inattentive Symptoms Subscale
The World Health Organization Adult Self-Report Scale (ASRS) symptom checklist is an 18-item tool to screen for probable ADHD in adults. The ASRS checklist asks respondents to indicate how they have felt and conducted themselves over the past 6 months in terms of frequency of inattention or hyperactivity symptoms, which are rated from 0 ("never") to 4 ("very often"). The checklist is divided into two parts and results in a "Part A" inattention subscore (range 0-36), a "Part B" hyperactivity/ impulsivity subscore (range 0-36), and a total score based on the full scale (range 0-72).
Time frame: Study Day 0 to Study Day 63
Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) ADHD Symptoms Total subscale
The Conners' Adult ADHD Rating Scales-Investigator Rated: Long Version (CAARS-Inv:L) has 66 items with multiple subscales.
Time frame: Study Day 0 to Study Day 63
Sheehan Disability Scale (SDS)
The Sheehan Disability Scale is a five-item, self-rated questionnaire designed to measure the extent to which a patient's disability due to an illness or health problem interferes with work/school, social life/leisure activities, and family life/home responsibilities.
Time frame: Study Day 0 to Study Day 63
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Hassman Research Institute
Berlin, New Jersey, United States