Trial Outcomes & Findings for Effectiveness of the Quotient® ADHD Assessment in a System of Care (NCT NCT02094612)

NCT ID: NCT02094612

Last Updated: 2017-07-17

Results Overview

Outcome measure reported is the number of participants with at least one 25% reduction in SNAP between visits. In treatment of ADHD, the therapeutic dose is defined as a 25% reduction in SNAP IV score between consecutive clinic visits. SNAP is itemized rating scale (Swanson, Nolan, and Pelham-IV Questionnaire) designed to measure ADHD symptoms and severity on a 4 point scale. It is based on DSM IV criteria, and is designed to measure attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) symptoms in children and young adults ages 6-18.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 207 participants
• Primary outcome timeframe: One month, 3 month and six month follow ups
• Results posted on: 2017-07-17

Participant Flow

Participant milestones

Measure	Usual Care Usual clinic ADHD care Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic	Usual Care Plus Assessment Usual clinic ADHD care plus the Quotient® Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers.
Overall Study STARTED	112	95
Overall Study 1 Month Follow up	67	50
Overall Study 3 Month Follow up	50	43
Overall Study 6 Month Follow up	33	25
Overall Study COMPLETED	33	25
Overall Study NOT COMPLETED	79	70

Reasons for withdrawal

Measure	Usual Care Usual clinic ADHD care Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic	Usual Care Plus Assessment Usual clinic ADHD care plus the Quotient® Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers.
Overall Study Lost to Follow-up	47	47
Overall Study Never started ADHD medication	32	23

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Usual Care n=112 Participants Usual clinic ADHD care Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic	Usual Care Plus Assessment n=95 Participants Usual clinic ADHD care plus the Quotient® Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers.	Total n=207 Participants Total of all reporting groups
Age, Categorical <=18 years	112 Participants n=112 Participants	95 Participants n=95 Participants	207 Participants n=207 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=112 Participants	0 Participants n=95 Participants	0 Participants n=207 Participants
Age, Categorical >=65 years	0 Participants n=112 Participants	0 Participants n=95 Participants	0 Participants n=207 Participants
Age, Continuous	8.5 years STANDARD_DEVIATION 1.9 • n=112 Participants	8.5 years STANDARD_DEVIATION 1.9 • n=95 Participants	8.5 years STANDARD_DEVIATION 1.9 • n=207 Participants
Sex: Female, Male Female	30 Participants n=112 Participants	27 Participants n=95 Participants	57 Participants n=207 Participants
Sex: Female, Male Male	82 Participants n=112 Participants	68 Participants n=95 Participants	150 Participants n=207 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	112 Participants n=112 Participants	95 Participants n=95 Participants	207 Participants n=207 Participants

PRIMARY outcome

Timeframe: One month, 3 month and six month follow ups

Population: Fifty eight (58) participants completed the study (i.e., had their 6 month follow up appointment) when the study was terminated.

Outcome measure reported is the number of participants with at least one 25% reduction in SNAP between visits. In treatment of ADHD, the therapeutic dose is defined as a 25% reduction in SNAP IV score between consecutive clinic visits. SNAP is itemized rating scale (Swanson, Nolan, and Pelham-IV Questionnaire) designed to measure ADHD symptoms and severity on a 4 point scale. It is based on DSM IV criteria, and is designed to measure attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) symptoms in children and young adults ages 6-18.

Outcome measures

Measure	Usual Care n=33 Participants Usual clinic ADHD care Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic	Usual Care Plus Assessment n=25 Participants Usual clinic ADHD care plus the Quotient® Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers.
Number of Participants With 25% Reduction in SNAP Scores	29 Participants	23 Participants

SECONDARY outcome

Timeframe: 6 months post baseline

Outcomes reported are average SNAP IV scores at baseline and 6 monhts. ADHD symptomatology is measured by the Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV), developed by James Swanson, Edith Nolan and William Pelham. We used the 18-item self-report inventory designed to measure attention deficit hyperactivity disorder (ADHD) symptoms in children and young adults. Each question measures the frequency of a variety of symptoms or behaviors.The subscales measure Inattention (9 items) and Hyperactivity/impulsivity (9 items), using 0-3 rating, 0="not at all", 1="just a little", 2="quite a bit", or 3="very much. Each 9-item subscale results in a score in range 0-27. The two subscale scores were averaged to create a single score for the 18-item SNAP.

Outcome measures

Measure	Usual Care n=33 Participants Usual clinic ADHD care Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic	Usual Care Plus Assessment n=25 Participants Usual clinic ADHD care plus the Quotient® Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers.
ADHD Symptomatology Average SNAP score at baseline	17.4 Score on a scale Standard Deviation 4.8	15.0 Score on a scale Standard Deviation 4.4
ADHD Symptomatology Average SNAP score at 6 months	9.0 Score on a scale Standard Deviation 5.6	8.6 Score on a scale Standard Deviation 5.9

SECONDARY outcome

Timeframe: Baseline and Six Months

Population: Academic performance was not measured, as there were a very low number of report cards collected (11 of 25 in Quotient arm and 16 of 33 in UC arm).

Academic performance will be measured by student report cards, and converted to a standardized scale

Outcome measures

Measure	Usual Care Usual clinic ADHD care Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic	Usual Care Plus Assessment Usual clinic ADHD care plus the Quotient® Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers.
Academic Performance	0	0

SECONDARY outcome

Timeframe: Baseline to Six Months

Update: Outcome measure reported is the # of participants who attended all study follow-up visits.

Use of pediatric health care services

Outcome measures

Measure	Usual Care n=33 Participants Usual clinic ADHD care Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic	Usual Care Plus Assessment n=25 Participants Usual clinic ADHD care plus the Quotient® Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers.
Persistence in Care	30 Participants	25 Participants

SECONDARY outcome

Timeframe: Baseline to six months

Update: Outcome reported is number of participants taking medication as prescribed at all study follow up visits.

Sustained use of ADHD medication

Outcome measures

Measure	Usual Care n=33 Participants Usual clinic ADHD care Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic	Usual Care Plus Assessment n=25 Participants Usual clinic ADHD care plus the Quotient® Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers.
Medication Adherence	18 Participants	17 Participants

SECONDARY outcome

Timeframe: Six months

Update: Outcome measure reported is number of participants who responded "very satisfied" with their ADHD care on 5-point Likert scale.

Likert scale single item measure of how satisfied the pediatric patient's parent was with care received

Outcome measures

Measure	Usual Care n=33 Participants Usual clinic ADHD care Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic	Usual Care Plus Assessment n=25 Participants Usual clinic ADHD care plus the Quotient® Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers.
Satisfaction With Care	28 Participants	20 Participants

SECONDARY outcome

Timeframe: Baseline to six months

Update: Outcome measure reported is number of psychiatric and ED visits during the 6 month follow up period.

Use of healthcare services outside of pediatrics, including the emergency room and psychiatric services.

Outcome measures

Measure	Usual Care n=33 Participants Usual clinic ADHD care Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic	Usual Care Plus Assessment n=25 Participants Usual clinic ADHD care plus the Quotient® Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers.
Other Health Services Use Number of psych visits	26 visits	22 visits
Other Health Services Use Number of ED visits	4 visits	2 visits

Adverse Events

Usual Care

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Plus Assessment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Usual Care n=112 participants at risk Usual clinic ADHD care Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic	Usual Care Plus Assessment n=112 participants at risk；n=95 participants at risk Usual clinic ADHD care plus the Quotient® Quotient®: Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers.
Respiratory, thoracic and mediastinal disorders Ashthma	0.89% 1/112 • Number of events 1 • 6 months (from baseline to 6 month follow up) Adverse events were assessed via periodic chart reviews of study participants..	0.00% 0/95 • 6 months (from baseline to 6 month follow up) Adverse events were assessed via periodic chart reviews of study participants..

Other adverse events

Adverse event data not reported

Additional Information

Monique Does, Project manager

Kaiser Permanente Division of Research

Phone: 510-891-3612

Email: monique.does@kp.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place