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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH062946 | U.S. NIH Grant/Contract | View source | |
| DSIR CT-CT |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Treatment | Placebo Comparator | No Medication, No Behavior Modification (BMOD) |
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| Low Dose Medication Only | Active Comparator | 0.15 mg/kg methylphenidate (MPH), No BMOD |
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| Medium Dose Medication Only | Active Comparator | 0.3 mg/kg MPH, No BMOD |
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| Higher Dose Medication Only | Active Comparator | 0.6 mg/kg MPH, No BMOD |
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| Low Intensity BMOD Only | Active Comparator | Placebo, Low Intensity BMOD |
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| Low Intensity BMOD + Low Dose Medication | Active Comparator | 0.15 mg/kg MPH, Low Intensity BMOD |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate 0.15 mg/kg | Drug | 0.15 m/kg/dose immediate-release methylphenidate |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Daily for 45 days |
| Classroom Behavior | Daily records of percentage of assigned problems completed by children in a 60-minute classroom period. | Daily for 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Satisfaction | Parent rating of treatment satisfaction with medication, behavioral treatment, and their combination,on a scale of 1 (bad) to 7 (good). | End of Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William E Pelham, PhD | Professor, Florida International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida International University Center for Children and Families | Miami | Florida | 33199 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Fabiano, G.A., Pelham, W.E., Gnagy, E.M., Wymbs, B.T., Chacko, A., Coles, E.K., Walker, K.S., Arnold, F., Burrows-MacLean, L., Massetti, G.M., & Hoffman, M.T. (2007). The single and combined effects of multiple intensities of behavior modification and multiple intensities of methylphenidate in a classroom setting. School Psychology Review, 36(2), 195-216. | ||
| 24429997 | Background | Pelham WE, Burrows-MacLean L, Gnagy EM, Fabiano GA, Coles EK, Wymbs BT, Chacko A, Walker KS, Wymbs F, Garefino A, Hoffman MT, Waxmonsky JG, Waschbusch DA. A dose-ranging study of behavioral and pharmacological treatment in social settings for children with ADHD. J Abnorm Child Psychol. 2014 Aug;42(6):1019-31. doi: 10.1007/s10802-013-9843-8. |
| Label | URL |
|---|---|
| Center for Children and Families Home Page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Low Intensity BMOD + Medium Dose Medication | Active Comparator | 0.3 mg/kg MPH, Low Intensity BMOD |
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| Low Intensity BMOD + Higher Dose Medication | Active Comparator | 0.6 mg/kg MPH, Low Intensity BMOD |
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| High Intensity BMOD Only | Active Comparator | Placebo, High Intensity BMOD |
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| High Intensity BMOD + Low Dose Medication | Active Comparator | 0.15 mg/kg MPH, High Intensity BMOD |
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| High Intensity BMOD + Medium Dose Medication | Active Comparator | 0.3 mg/kg MPH, High Intensity BMOD |
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| High Intensity BMOD + Higher Dose Medication | Active Comparator | 0.6 mg/kg MPH, High Intensity BMOD |
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| Low-Intensity BMOD | Behavioral | Lower-intensity behavioral treatment package. |
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| Methylphenidate 0.3 mg/kg | Drug | 0.3 mg/kg/dose immediate-release methylphenidate |
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| Placebo | Drug |
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| Methylphenidate 0.6 mg/kg | Drug | 0.3 mg/kg/dose immediate-release methylphenidate |
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| High Intensity BMOD | Behavioral | Comprehensive high-intensity Summer Treatment Program (STP) |
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| Center for Children and Families, University at Buffalo |
| Buffalo |
| New York |
| 14214 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Within-Subject Treatment | All subjects completed a within-subjects crossover of 3 levels of behavior modification and 4 levels of medication. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | Posted | Mean | Standard Deviation | Number of Observed Behaviors | Daily for 45 days |
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| Primary | Classroom Behavior | Daily records of percentage of assigned problems completed by children in a 60-minute classroom period. | Posted | Mean | Standard Deviation | Percentage of Work Completed | Daily for 45 days |
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| Secondary | Treatment Satisfaction | Parent rating of treatment satisfaction with medication, behavioral treatment, and their combination,on a scale of 1 (bad) to 7 (good). | Posted | Mean | Standard Deviation | Units on scale | End of Treatment |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo | 0 | 154 | 3 | 153 | ||
| EG001 | Low Dose Medication | 0.15 mg/kg MPH, No BMOD | 0 | 154 | 2 | 153 | ||
| EG002 | Medium Dose Medication | 0.3 mg/kg MPH, No BMOD | 0 | 154 | 3 | 153 | ||
| EG003 | Higher Dose Medication | 0.6 mg/kg MPH, No BMOD | 0 | 154 | 17 | 153 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tics | General disorders | Systematic Assessment | Parent Rating of Moderate or Severe verbal or motor tics on the Pittsburgh Side Effects Rating Scale. |
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| Picking at skin, nail biting | General disorders | Systematic Assessment | Parent rating of Moderate or Severe on Pittsburgh Side Effects Rating Scale for picking at skin, nail biting, etc. |
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| Buccal-Lingual Movements | General disorders | Systematic Assessment | Parent rating of Moderate or Severe on Pittsburgh Side Effects Rating Scale for buccal-lingual movements |
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| Worried/Anxious | General disorders | Systematic Assessment | Parent rating of Moderate or Severe on Pittsburgh Side Effect Rating Scale for worry or anxiety |
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| Dull, tired, listless | General disorders | Systematic Assessment | Parent Rating of Moderate or Severe on Pittsburgh Side Effect Rating Scale for being dull, tired or listless. |
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| Headache | General disorders | Systematic Assessment | Parent Report of Moderate or Severe on Pittsburgh Side Effect Rating Scale for Headache. |
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| Stomachache | Gastrointestinal disorders | Systematic Assessment | Parent Rating of Moderate or Severe on Pittsburgh Side Effect Rating Scale for Stomach ache. |
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| Irritability | General disorders | Systematic Assessment | Parent Rating of Moderate or Severe on Pittsburgh Side Effects Rating Scale for Crabbiness/Irritability |
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| Tearful, sad,depressed | General disorders | Systematic Assessment | Parent Rating of Moderate or Severe on Pittsburgh Side Effects Rating Scale for tearfulness, sadness, or depression. |
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| Social Withdrawal | Social circumstances | Systematic Assessment | Parent Rating of Moderate or Severe on Pittsburgh Side Effects Rating Scale for social withdrawal |
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| Hallucinations | Psychiatric disorders | Systematic Assessment | Parent rating of Moderate or Severe on Pittsburgh Side Effects Rating Scale for hallucinations. |
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| Trouble Sleeping | General disorders | Systematic Assessment | Parent Rating of Moderate or Severe on Pittsburgh Side Effects Rating Scale for trouble sleeping. |
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| Appetite Loss | General disorders | Systematic Assessment | Parent Rating of Moderate or Severe on Pittsburgh side Effects Rating Scale for appetite loss. |
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Highly structured environment and direct observational measures were used. Additional study in natural school and home settings will be necessary.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William E. Pelham, Jr. | Florida International University | 305-348-3002 | wpelham@fiu.edu |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG005 | Low Intensity BMOD + Low Dose Medication | 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. |
| OG006 | 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 |
| OG007 | 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 |
| OG008 | High Intensity BMOD Only | Placebo, High Intensity BMOD High Intensity BMOD: Comprehensive high-intensity STP |
| OG009 | 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 |
| OG010 | 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 |
| OG011 | 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 |
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