Attention Deficit Disorder With Hyperactivity
Conditions
Brief summary
The purpose of this study is to determine the effectiveness of behavioral treatment, drug treatment, and combined treatment for children with Attention Deficit Hyperactivity Disorder (ADHD). This study will also examine the interactions between different levels of behavioral and drug treatments.
Detailed description
Participants attend a summer treatment program each Monday-Friday for 9 weeks. They participate in group recreational and classroom activities, with 12 children and 5 staff per group. Three behavioral conditions (no behavioral modification, low-intensity behavioral modification, and high-intensity behavioral modification) are delivered in random order, with each condition lasting 3 weeks. Along with the behavioral treatment conditions, children receive 1 of 4 medication doses (placebo, 0.15 mg/kg methylphenidate, 0.3 mg/kg methylphenidate, or 0.6 mg/kg methylphenidate) in random order, with each dose varied daily and repeated 3 or 4 times within each behavioral treatment condition. Measures include frequency counts of positive and negative behaviors, academic productivity and accuracy in the classroom, and counselor, parent, and teacher ratings of benefits and side effects. Parents attend training sessions and implement behavioral programs at home.
Interventions
DRUGMethylphenidate 0.15 mg/kg
0.15 m/kg/dose immediate-release methylphenidate
BEHAVIORALLow-Intensity BMOD
Lower-intensity behavioral treatment package.
DRUGMethylphenidate 0.3 mg/kg
0.3 mg/kg/dose immediate-release methylphenidate
DRUGPlacebo
DRUGMethylphenidate 0.6 mg/kg
0.3 mg/kg/dose immediate-release methylphenidate
BEHAVIORALHigh Intensity BMOD
Comprehensive high-intensity Summer Treatment Program (STP)
Sponsors
National Institute of Mental Health (NIMH)
Florida International University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Attention Deficit Hyperactivity Disorder * IQ \>= 80
Exclusion criteria
* History of seizures or other neurological problems * Medical history that would involve considerable risk in taking stimulant medication * History or concurrent diagnosis of any of the following disorders: pervasive developmental disorder, schizophrenia or other psychotic disorders, sexual disorder, organic mental disorder, or eating disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Social Behavior-Negative Verbalizations | Daily for 45 days | 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. |
| Classroom Behavior | Daily for 45 days | Daily records of percentage of assigned problems completed by children in a 60-minute classroom period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Satisfaction | End of Treatment | Parent rating of treatment satisfaction with medication, behavioral treatment, and their combination,on a scale of 1 (bad) to 7 (good). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Within-Subject Treatment All subjects completed a within-subjects crossover of 3 levels of behavior modification and 4 levels of medication. | 154 |
| Total | 154 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Within-Subject Treatment |
|---|---|
| Age, Categorical <=18 years | 154 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 9.15 Years STANDARD_DEVIATION 2.02 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants |
| Race (NIH/OMB) More than one race | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 122 Participants |
| Region of Enrollment United States | 154 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 130 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 153 | 2 / 153 | 3 / 153 | 17 / 153 |
| serious Total, serious adverse events | 0 / 154 | 0 / 154 | 0 / 154 | 0 / 154 |
Outcome results
Primary
Classroom Behavior
Daily records of percentage of assigned problems completed by children in a 60-minute classroom period.
Time frame: Daily for 45 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Classroom Behavior | 37 Percentage of Work Completed | Standard Deviation 23 |
| Low Dose Medication Only | Classroom Behavior | 53 Percentage of Work Completed | Standard Deviation 26 |
| Medium Dose Medication Only | Classroom Behavior | 57 Percentage of Work Completed | Standard Deviation 24 |
| Higher Dose Medication Only | Classroom Behavior | 61 Percentage of Work Completed | Standard Deviation 23 |
| Low Intensity BMOD Only | Classroom Behavior | 53 Percentage of Work Completed | Standard Deviation 21 |
| Low Intensity BMOD + Low Dose Medication | Classroom Behavior | 67 Percentage of Work Completed | Standard Deviation 18 |
| Low Intensity BMOD + Medium Dose Medication | Classroom Behavior | 72 Percentage of Work Completed | Standard Deviation 19 |
| Low Intensity BMOD + Higher Dose Medication | Classroom Behavior | 75 Percentage of Work Completed | Standard Deviation 38 |
| High Intensity BMOD Only | Classroom Behavior | 58 Percentage of Work Completed | Standard Deviation 22 |
| High Intensity BMOD + Low Dose Medication | Classroom Behavior | 72 Percentage of Work Completed | Standard Deviation 17 |
| High Intensity BMOD + Medium Dose Medication | Classroom Behavior | 75 Percentage of Work Completed | Standard Deviation 14 |
| High Intensity BMOD + Higher Dose Medication | Classroom Behavior | 76 Percentage of Work Completed | Standard Deviation 15 |
Primary
Social Behavior-Negative Verbalizations
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.
Time frame: Daily for 45 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Social Behavior-Negative Verbalizations | 73.32 Number of Observed Behaviors | Standard Deviation 127.11 |
| Low Dose Medication Only | Social Behavior-Negative Verbalizations | 45.41 Number of Observed Behaviors | Standard Deviation 85.23 |
| Medium Dose Medication Only | Social Behavior-Negative Verbalizations | 28.41 Number of Observed Behaviors | Standard Deviation 59.11 |
| Higher Dose Medication Only | Social Behavior-Negative Verbalizations | 15.08 Number of Observed Behaviors | Standard Deviation 29.61 |
| Low Intensity BMOD Only | Social Behavior-Negative Verbalizations | 27.06 Number of Observed Behaviors | Standard Deviation 45.77 |
| Low Intensity BMOD + Low Dose Medication | Social Behavior-Negative Verbalizations | 13.70 Number of Observed Behaviors | Standard Deviation 27.99 |
| Low Intensity BMOD + Medium Dose Medication | Social Behavior-Negative Verbalizations | 9.27 Number of Observed Behaviors | Standard Deviation 20.05 |
| Low Intensity BMOD + Higher Dose Medication | Social Behavior-Negative Verbalizations | 4.28 Number of Observed Behaviors | Standard Deviation 9.91 |
| High Intensity BMOD Only | Social Behavior-Negative Verbalizations | 20.23 Number of Observed Behaviors | Standard Deviation 41.13 |
| High Intensity BMOD + Low Dose Medication | Social Behavior-Negative Verbalizations | 7.61 Number of Observed Behaviors | Standard Deviation 19.21 |
| High Intensity BMOD + Medium Dose Medication | Social Behavior-Negative Verbalizations | 4.08 Number of Observed Behaviors | Standard Deviation 8.59 |
| High Intensity BMOD + Higher Dose Medication | Social Behavior-Negative Verbalizations | 2.49 Number of Observed Behaviors | Standard Deviation 7.5 |
Secondary
Treatment Satisfaction
Parent rating of treatment satisfaction with medication, behavioral treatment, and their combination,on a scale of 1 (bad) to 7 (good).
Time frame: End of Treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Treatment Satisfaction | 1.8 Units on scale | Standard Deviation 1.2 |
| Low Dose Medication Only | Treatment Satisfaction | 2.7 Units on scale | Standard Deviation 1.4 |
| Medium Dose Medication Only | Treatment Satisfaction | 3.8 Units on scale | Standard Deviation 1.6 |
| Higher Dose Medication Only | Treatment Satisfaction | 3.5 Units on scale | Standard Deviation 1.3 |
| Low Intensity BMOD Only | Treatment Satisfaction | 4.6 Units on scale | Standard Deviation 1.3 |
| Low Intensity BMOD + Low Dose Medication | Treatment Satisfaction | 5.6 Units on scale | Standard Deviation 1.2 |