Attention Deficit and Disruptive Behavior Disorders, Attention Deficit Disorder With Hyperactivity
Conditions
Keywords
Attention Deficit and Disruptive Behavior Disorders, Attention Deficit Disorder with Hyperactivity, Pediatrics, Patient Outcome Assessment
Brief summary
The study goal is to examine whether the use of an objective computerized neuroassessment (the Quotient System) for Attention-Deficit/Hyperactivity Disorder (ADHD) is related to improved outcomes among pediatric patients being assessed and treated for ADHD.
Detailed description
This study is a randomized, controlled trial using a 2-phase data collection. The first phase is the initial assessment for ADHD and includes all patients eligible to be assessed for ADHD as determined by their clinician in the course of usual care. The baseline measurements will be used to compare groups at baseline, and also for longitudinal analyses of medication management. Patients are randomized at this point. Patients in both treatment arms who then receive an ADHD diagnosis and who start medication for ADHD will be eligible for the second phase of the study: three follow-up assessments over six months. Patients who do not have an ADHD diagnosis will not continue in the study, and will be treated by their clinician as usual.
Interventions
DEVICEQuotient®
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.
BEHAVIORALUsual Clinic ADHD Care
Usual ADHD care as provided by the clinic
Sponsors
Pearson/Clinical Assessment
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* All patients within the specified age range who are English speaking and who are presenting for ADHD assessment are eligible. An additional criterion is consent to be randomized.
Exclusion criteria
* Non English speaking * Refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 25% Reduction in SNAP Scores | One month, 3 month and six month follow ups | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Academic Performance | Baseline and Six Months | Academic performance will be measured by student report cards, and converted to a standardized scale |
| Persistence in Care | 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 |
| ADHD Symptomatology | 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. |
| Satisfaction With Care | 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 |
| Other Health Services Use | 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. |
| Medication Adherence | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Usual clinic ADHD care
Usual Clinic ADHD Care: Usual ADHD care as provided by the clinic | 112 |
| 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. | 95 |
| Total | 207 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 47 | 47 |
| Overall Study | Never started ADHD medication | 32 | 23 |
Baseline characteristics
| Characteristic | Usual Care Plus Assessment | Total | Usual Care |
|---|---|---|---|
| Age, Categorical <=18 years | 95 Participants | 207 Participants | 112 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8.5 years STANDARD_DEVIATION 1.9 | 8.5 years STANDARD_DEVIATION 1.9 | 8.5 years STANDARD_DEVIATION 1.9 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 95 Participants | 207 Participants | 112 Participants |
| Sex: Female, Male Female | 27 Participants | 57 Participants | 30 Participants |
| Sex: Female, Male Male | 68 Participants | 150 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 112 | 0 / 95 |
| other Total, other adverse events | 0 / 112 | 0 / 112 |
| serious Total, serious adverse events | 1 / 112 | 0 / 95 |
Outcome results
Primary
Number of Participants With 25% Reduction in SNAP Scores
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Number of Participants With 25% Reduction in SNAP Scores | 29 Participants |
| Usual Care Plus Assessment | Number of Participants With 25% Reduction in SNAP Scores | 23 Participants |
Secondary
Academic Performance
Academic performance will be measured by student report cards, and converted to a standardized scale
Time frame: 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).
| Arm | Measure | Value |
|---|---|---|
| Usual Care | Academic Performance | 0 |
| Usual Care Plus Assessment | Academic Performance | 0 |
Secondary
ADHD Symptomatology
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.
Time frame: 6 months post baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | ADHD Symptomatology | Average SNAP score at baseline | 17.4 Score on a scale | Standard Deviation 4.8 |
| Usual Care | ADHD Symptomatology | Average SNAP score at 6 months | 9.0 Score on a scale | Standard Deviation 5.6 |
| Usual Care Plus Assessment | ADHD Symptomatology | Average SNAP score at baseline | 15.0 Score on a scale | Standard Deviation 4.4 |
| Usual Care Plus Assessment | ADHD Symptomatology | Average SNAP score at 6 months | 8.6 Score on a scale | Standard Deviation 5.9 |
Secondary
Medication Adherence
Update: Outcome reported is number of participants taking medication as prescribed at all study follow up visits. Sustained use of ADHD medication
Time frame: Baseline to six months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Medication Adherence | 18 Participants |
| Usual Care Plus Assessment | Medication Adherence | 17 Participants |
Secondary
Other Health Services Use
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.
Time frame: Baseline to six months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Other Health Services Use | Number of psych visits | 26 visits |
| Usual Care | Other Health Services Use | Number of ED visits | 4 visits |
| Usual Care Plus Assessment | Other Health Services Use | Number of psych visits | 22 visits |
| Usual Care Plus Assessment | Other Health Services Use | Number of ED visits | 2 visits |
Secondary
Persistence in Care
Update: Outcome measure reported is the # of participants who attended all study follow-up visits. Use of pediatric health care services
Time frame: Baseline to Six Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Persistence in Care | 30 Participants |
| Usual Care Plus Assessment | Persistence in Care | 25 Participants |
Secondary
Satisfaction With Care
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
Time frame: Six months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Satisfaction With Care | 28 Participants |
| Usual Care Plus Assessment | Satisfaction With Care | 20 Participants |