Trial Outcomes & Findings for Behavioral Treatment, Drug Treatment, and Combined Treatment for Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT00050622)
NCT ID: NCT00050622
Last Updated: 2016-09-30
Results Overview
Sum of daily frequency of Verbal Abuse toward staff members, Teasing toward peers, and Cursing/Swearing as defined by a behavioral point system that doubles as an objective measure of children's behavior. All instances of these behaviors were reported and noted as they occur throughout daily activities.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
154 participants
Primary outcome timeframe
Daily for 45 days
Results posted on
2016-09-30
Participant Flow
Participant milestones
| Measure |
Within-Subject Treatment
All subjects received a within-subjects crossover of 3 levels of behavior modification, randomized in 3-week units, and 4 levels of medication, randomized on a daily basis. Thus each participant experienced all 12 combinations of No, Low, and High Intensity BMOD crossed with Placebo, 0.15 mg/kg MPH, 0.3 mg/kg MPH, and 0.6 mg/kg MPH conditions, with specific conditions changing daily.
|
|---|---|
|
Overall Study
STARTED
|
154
|
|
Overall Study
COMPLETED
|
153
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Within-Subject Treatment
All subjects received a within-subjects crossover of 3 levels of behavior modification, randomized in 3-week units, and 4 levels of medication, randomized on a daily basis. Thus each participant experienced all 12 combinations of No, Low, and High Intensity BMOD crossed with Placebo, 0.15 mg/kg MPH, 0.3 mg/kg MPH, and 0.6 mg/kg MPH conditions, with specific conditions changing daily.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Behavioral Treatment, Drug Treatment, and Combined Treatment for Attention Deficit Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
Within-Subject Treatment
n=154 Participants
All subjects completed a within-subjects crossover of 3 levels of behavior modification and 4 levels of medication.
|
|---|---|
|
Age, Categorical
<=18 years
|
154 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
9.15 Years
STANDARD_DEVIATION 2.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
130 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
122 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
154 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Daily for 45 daysSum of daily frequency of Verbal Abuse toward staff members, Teasing toward peers, and Cursing/Swearing as defined by a behavioral point system that doubles as an objective measure of children's behavior. All instances of these behaviors were reported and noted as they occur throughout daily activities.
Outcome measures
| Measure |
No Treatment
n=153 Participants
No Medication, No BMOD
Placebo
|
Low Dose Medication Only
n=153 Participants
0.15 mg/kg MPH, No BMOD
Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate
|
Medium Dose Medication Only
n=153 Participants
0.3 mg/kg MPH, No BMOD
Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate
|
Higher Dose Medication Only
n=153 Participants
0.6 mg/kg MPH, No BMOD
Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate
|
Low Intensity BMOD Only
n=153 Participants
Placebo, Low Intensity BMOD
Low-Intensity BMOD: Lower-intensity behavioral treatment package.
Placebo
|
Low Intensity BMOD + Low Dose Medication
n=153 Participants
0.15 mg/kg MPH, Low Intensity BMOD
Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate
Low-Intensity BMOD: Lower-intensity behavioral treatment package.
|
Low Intensity BMOD + Medium Dose Medication
n=153 Participants
0.3 mg/kg MPH, Low Intensity BMOD
Low-Intensity BMOD: Lower-intensity behavioral treatment package.
Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate
|
Low Intensity BMOD + Higher Dose Medication
n=153 Participants
0.6 mg/kg MPH, Low Intensity BMOD
Low-Intensity BMOD: Lower-intensity behavioral treatment package.
Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate
|
High Intensity BMOD Only
n=153 Participants
Placebo, High Intensity BMOD
High Intensity BMOD: Comprehensive high-intensity STP
|
High Intensity BMOD + Low Dose Medication
n=153 Participants
0.15 mg/kg MPH, High Intensity BMOD
Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate
High Intensity BMOD: Comprehensive high-intensity STP
|
High Intensity BMOD + Medium Dose Medication
n=153 Participants
0.3 mg/kg MPH, High Intensity BMOD
Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate
High Intensity BMOD: Comprehensive high-intensity STP
|
High Intensity BMOD + Higher Dose Medication
n=153 Participants
0.6 mg/kg MPH, High Intensity BMOD
Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate
High Intensity BMOD: Comprehensive high-intensity STP
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Social Behavior-Negative Verbalizations
|
73.32 Number of Observed Behaviors
Standard Deviation 127.11
|
45.41 Number of Observed Behaviors
Standard Deviation 85.23
|
28.41 Number of Observed Behaviors
Standard Deviation 59.11
|
15.08 Number of Observed Behaviors
Standard Deviation 29.61
|
27.06 Number of Observed Behaviors
Standard Deviation 45.77
|
13.70 Number of Observed Behaviors
Standard Deviation 27.99
|
9.27 Number of Observed Behaviors
Standard Deviation 20.05
|
4.28 Number of Observed Behaviors
Standard Deviation 9.91
|
20.23 Number of Observed Behaviors
Standard Deviation 41.13
|
7.61 Number of Observed Behaviors
Standard Deviation 19.21
|
4.08 Number of Observed Behaviors
Standard Deviation 8.59
|
2.49 Number of Observed Behaviors
Standard Deviation 7.50
|
PRIMARY outcome
Timeframe: Daily for 45 daysDaily records of percentage of assigned problems completed by children in a 60-minute classroom period.
Outcome measures
| Measure |
No Treatment
n=153 Participants
No Medication, No BMOD
Placebo
|
Low Dose Medication Only
n=153 Participants
0.15 mg/kg MPH, No BMOD
Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate
|
Medium Dose Medication Only
n=153 Participants
0.3 mg/kg MPH, No BMOD
Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate
|
Higher Dose Medication Only
n=153 Participants
0.6 mg/kg MPH, No BMOD
Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate
|
Low Intensity BMOD Only
n=153 Participants
Placebo, Low Intensity BMOD
Low-Intensity BMOD: Lower-intensity behavioral treatment package.
Placebo
|
Low Intensity BMOD + Low Dose Medication
n=153 Participants
0.15 mg/kg MPH, Low Intensity BMOD
Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate
Low-Intensity BMOD: Lower-intensity behavioral treatment package.
|
Low Intensity BMOD + Medium Dose Medication
n=153 Participants
0.3 mg/kg MPH, Low Intensity BMOD
Low-Intensity BMOD: Lower-intensity behavioral treatment package.
Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate
|
Low Intensity BMOD + Higher Dose Medication
n=153 Participants
0.6 mg/kg MPH, Low Intensity BMOD
Low-Intensity BMOD: Lower-intensity behavioral treatment package.
Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate
|
High Intensity BMOD Only
n=153 Participants
Placebo, High Intensity BMOD
High Intensity BMOD: Comprehensive high-intensity STP
|
High Intensity BMOD + Low Dose Medication
n=153 Participants
0.15 mg/kg MPH, High Intensity BMOD
Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate
High Intensity BMOD: Comprehensive high-intensity STP
|
High Intensity BMOD + Medium Dose Medication
n=153 Participants
0.3 mg/kg MPH, High Intensity BMOD
Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate
High Intensity BMOD: Comprehensive high-intensity STP
|
High Intensity BMOD + Higher Dose Medication
n=153 Participants
0.6 mg/kg MPH, High Intensity BMOD
Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate
High Intensity BMOD: Comprehensive high-intensity STP
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Classroom Behavior
|
37 Percentage of Work Completed
Standard Deviation 23
|
53 Percentage of Work Completed
Standard Deviation 26
|
57 Percentage of Work Completed
Standard Deviation 24
|
61 Percentage of Work Completed
Standard Deviation 23
|
53 Percentage of Work Completed
Standard Deviation 21
|
67 Percentage of Work Completed
Standard Deviation 18
|
72 Percentage of Work Completed
Standard Deviation 19
|
75 Percentage of Work Completed
Standard Deviation 38
|
58 Percentage of Work Completed
Standard Deviation 22
|
72 Percentage of Work Completed
Standard Deviation 17
|
75 Percentage of Work Completed
Standard Deviation 14
|
76 Percentage of Work Completed
Standard Deviation 15
|
SECONDARY outcome
Timeframe: End of TreatmentParent rating of treatment satisfaction with medication, behavioral treatment, and their combination,on a scale of 1 (bad) to 7 (good).
Outcome measures
| Measure |
No Treatment
n=143 Participants
No Medication, No BMOD
Placebo
|
Low Dose Medication Only
n=143 Participants
0.15 mg/kg MPH, No BMOD
Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate
|
Medium Dose Medication Only
n=143 Participants
0.3 mg/kg MPH, No BMOD
Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate
|
Higher Dose Medication Only
n=143 Participants
0.6 mg/kg MPH, No BMOD
Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate
|
Low Intensity BMOD Only
n=143 Participants
Placebo, Low Intensity BMOD
Low-Intensity BMOD: Lower-intensity behavioral treatment package.
Placebo
|
Low Intensity BMOD + Low Dose Medication
n=143 Participants
0.15 mg/kg MPH, Low Intensity BMOD
Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate
Low-Intensity BMOD: Lower-intensity behavioral treatment package.
|
Low Intensity BMOD + Medium Dose Medication
0.3 mg/kg MPH, Low Intensity BMOD
Low-Intensity BMOD: Lower-intensity behavioral treatment package.
Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate
|
Low Intensity BMOD + Higher Dose Medication
0.6 mg/kg MPH, Low Intensity BMOD
Low-Intensity BMOD: Lower-intensity behavioral treatment package.
Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate
|
High Intensity BMOD Only
Placebo, High Intensity BMOD
High Intensity BMOD: Comprehensive high-intensity STP
|
High Intensity BMOD + Low Dose Medication
0.15 mg/kg MPH, High Intensity BMOD
Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate
High Intensity BMOD: Comprehensive high-intensity STP
|
High Intensity BMOD + Medium Dose Medication
0.3 mg/kg MPH, High Intensity BMOD
Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate
High Intensity BMOD: Comprehensive high-intensity STP
|
High Intensity BMOD + Higher Dose Medication
0.6 mg/kg MPH, High Intensity BMOD
Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate
High Intensity BMOD: Comprehensive high-intensity STP
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Satisfaction
|
1.8 Units on scale
Standard Deviation 1.2
|
2.7 Units on scale
Standard Deviation 1.4
|
3.8 Units on scale
Standard Deviation 1.6
|
3.5 Units on scale
Standard Deviation 1.3
|
4.6 Units on scale
Standard Deviation 1.3
|
5.6 Units on scale
Standard Deviation 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Low Dose Medication
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Medium Dose Medication
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Higher Dose Medication
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=153 participants at risk；n=154 participants at risk
Placebo
|
Low Dose Medication
n=153 participants at risk；n=154 participants at risk
0.15 mg/kg MPH, No BMOD
|
Medium Dose Medication
n=153 participants at risk；n=154 participants at risk
0.3 mg/kg MPH, No BMOD
|
Higher Dose Medication
n=153 participants at risk；n=154 participants at risk
0.6 mg/kg MPH, No BMOD
|
|---|---|---|---|---|
|
General disorders
Tics
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.65%
1/153 • Number of events 1 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
2.0%
3/153 • Number of events 3 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
|
General disorders
Picking at skin, nail biting
|
1.3%
2/153 • Number of events 2 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.65%
1/153 • Number of events 1 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.65%
1/153 • Number of events 1 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
1.3%
2/153 • Number of events 2 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
|
General disorders
Buccal-Lingual Movements
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
2.6%
4/153 • Number of events 4 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
|
General disorders
Worried/Anxious
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.65%
1/153 • Number of events 1 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
2.0%
3/153 • Number of events 3 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
|
General disorders
Dull, tired, listless
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
1.3%
2/153 • Number of events 2 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
|
General disorders
Headache
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.65%
1/153 • Number of events 1 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
|
Gastrointestinal disorders
Stomachache
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.65%
1/153 • Number of events 1 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
|
General disorders
Irritability
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
1.3%
2/153 • Number of events 2 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
|
General disorders
Tearful, sad,depressed
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
2.0%
3/153 • Number of events 3 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
|
Social circumstances
Social Withdrawal
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
1.3%
2/153 • Number of events 2 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.65%
1/153 • Number of events 1 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
|
General disorders
Trouble Sleeping
|
0.65%
1/153 • Number of events 1 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.65%
1/153 • Number of events 1 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
3.3%
5/153 • Number of events 5 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
|
General disorders
Appetite Loss
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.65%
1/153 • Number of events 1 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
0.00%
0/153 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
5.9%
9/153 • Number of events 9 • Daily for 45 days
Parents completed the Pittsburgh Side Effects Rating Scale daily. Side effects were rated as None, Mild, Moderate, or Severe for common side effects of stimulant medication. Because the Side Effects Rating Scale applies only to medication side effects, treatment arms are collapsed across the three behavioral conditions.
|
Additional Information
William E. Pelham, Jr.
Florida International University
Phone: 305-348-3002
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place