Attention Deficit Disorder With HyperactivityNCT00050622

Behavioral Treatment, Drug Treatment, and Combined Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

A study testing Methylphenidate 0.15 mg/kg, Low-Intensity BMOD and Methylphenidate 0.3 mg/kg in people with Attention Deficit Disorder With Hyperactivity, run by Florida International University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 5 to 12 years
Conditions the study is for: Attention Deficit Disorder With Hyperactivity
What is being tested?: Methylphenidate 0.15 mg/kg, Low-Intensity BMOD and Methylphenidate 0.3 mg/kg
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 154 participants
Where: 2 sitesUnited States
Study dates: Sep 2001to Jun 2005
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

Attention Deficit Hyperactivity Disorder
IQ >= 80

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Center for Children and Families, University at Buffalo
Buffalo, New York, 14214
Florida International University Center for Children and Families
Miami, Florida, 33199

Other trials in United States

About this study

Official title: ADHD Treatment: Comparative and Combined Dosage Effects

Read the 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.

Conditions: Attention Deficit Disorder With Hyperactivity
Being tested: Methylphenidate 0.15 mg/kg, Low-Intensity BMOD, Methylphenidate 0.3 mg/kg, Placebo, Methylphenidate 0.6 mg/kg
Medical subject headings: Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Methylphenidate 0.15 mg/kgDrug
0.15 m/kg/dose immediate-release methylphenidate
Low-Intensity BMODBehavioural
Lower-intensity behavioral treatment package.
Methylphenidate 0.3 mg/kgDrug
0.3 mg/kg/dose immediate-release methylphenidate
PlaceboDrug
Methylphenidate 0.6 mg/kgDrug
0.3 mg/kg/dose immediate-release methylphenidate
High Intensity BMODBehavioural
Comprehensive high-intensity Summer Treatment Program (STP)

Study groups in NCT00050622
Study group	Role	What they receive
No Treatment	Placebo comparator	No Medication, No Behavior Modification (BMOD) Receives: Drug: Placebo
Low Dose Medication Only	Active comparator	0.15 mg/kg methylphenidate (MPH), No BMOD Receives: Drug: Methylphenidate 0.15 mg/kg
Medium Dose Medication Only	Active comparator	0.3 mg/kg MPH, No BMOD Receives: Drug: Methylphenidate 0.3 mg/kg
Higher Dose Medication Only	Active comparator	0.6 mg/kg MPH, No BMOD Receives: Drug: Methylphenidate 0.6 mg/kg
Low Intensity BMOD Only	Active comparator	Placebo, Low Intensity BMOD Receives: Behavioral: Low-Intensity BMOD; Drug: Placebo
Low Intensity BMOD + Low Dose Medication	Active comparator	0.15 mg/kg MPH, Low Intensity BMOD Receives: Drug: Methylphenidate 0.15 mg/kg; Behavioral: Low-Intensity BMOD
Low Intensity BMOD + Medium Dose Medication	Active comparator	0.3 mg/kg MPH, Low Intensity BMOD Receives: Behavioral: Low-Intensity BMOD; Drug: Methylphenidate 0.3 mg/kg
Low Intensity BMOD + Higher Dose Medication	Active comparator	0.6 mg/kg MPH, Low Intensity BMOD Receives: Behavioral: Low-Intensity BMOD; Drug: Methylphenidate 0.6 mg/kg
High Intensity BMOD Only	Active comparator	Placebo, High Intensity BMOD Receives: Behavioral: High Intensity BMOD
High Intensity BMOD + Low Dose Medication	Active comparator	0.15 mg/kg MPH, High Intensity BMOD Receives: Drug: Methylphenidate 0.15 mg/kg; Behavioral: High Intensity BMOD
High Intensity BMOD + Medium Dose Medication	Active comparator	0.3 mg/kg MPH, High Intensity BMOD Receives: Drug: Methylphenidate 0.3 mg/kg; Behavioral: High Intensity BMOD
High Intensity BMOD + Higher Dose Medication	Active comparator	0.6 mg/kg MPH, High Intensity BMOD Receives: Drug: Methylphenidate 0.6 mg/kg; Behavioral: High Intensity BMOD

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Daily for 45 days
Classroom Behavior
Daily records of percentage of assigned problems completed by children in a 60-minute classroom period.
Measured: Daily for 45 days

Secondary outcomes (1)

Treatment Satisfaction
Parent rating of treatment satisfaction with medication, behavioral treatment, and their combination,on a scale of 1 (bad) to 7 (good).
Measured: End of Treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2001Jun 2005

First posted17 Dec 2002 (estimated)
Study startSep 2001
Primary completionAug 2004
Study completionJun 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 154 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00050622
Sponsor's protocol ID: R01MH062946
Other IDs: R01MH062946, DSIR CT-CT
Status last verified: Aug 2016
First submitted: 16 Dec 2002
Last updated: 30 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes

Publications

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.
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.
PubMed 24429997

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
RecruitingPhase 3
A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation

All Attention Deficit Disorder With Hyperactivity trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ADHD Treatment: Comparative and Combined Dosage Effects
ClinicalTrials.gov ID: NCT00050622
Acronym / sponsor ID: R01MH062946
Conditions: Attention Deficit Disorder With Hyperactivity
Study type: Interventional
Recruitment status: Completed
Enrolment: 154 participants (actual)
Lead sponsor: Florida International UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Sep 2001
Primary completion: Aug 2004 (actual)
Study completion: Jun 2005 (actual)
First posted: 17 Dec 2002 (estimated)
Results: Posted 30 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 12

Arm	Type	Receives
No Treatment	Placebo comparator	Drug: PlaceboNo Medication, No Behavior Modification (BMOD)
Low Dose Medication Only	Active comparator	Drug: Methylphenidate 0.15 mg/kg0.15 mg/kg methylphenidate (MPH), No BMOD
Medium Dose Medication Only	Active comparator	Drug: Methylphenidate 0.3 mg/kg0.3 mg/kg MPH, No BMOD
Higher Dose Medication Only	Active comparator	Drug: Methylphenidate 0.6 mg/kg0.6 mg/kg MPH, No BMOD
Low Intensity BMOD Only	Active comparator	Behavioral: Low-Intensity BMOD, Drug: PlaceboPlacebo, Low Intensity BMOD
Low Intensity BMOD + Low Dose Medication	Active comparator	Drug: Methylphenidate 0.15 mg/kg, Behavioral: Low-Intensity BMOD0.15 mg/kg MPH, Low Intensity BMOD
Low Intensity BMOD + Medium Dose Medication	Active comparator	Behavioral: Low-Intensity BMOD, Drug: Methylphenidate 0.3 mg/kg0.3 mg/kg MPH, Low Intensity BMOD
Low Intensity BMOD + Higher Dose Medication	Active comparator	Behavioral: Low-Intensity BMOD, Drug: Methylphenidate 0.6 mg/kg0.6 mg/kg MPH, Low Intensity BMOD
High Intensity BMOD Only	Active comparator	Behavioral: High Intensity BMODPlacebo, High Intensity BMOD
High Intensity BMOD + Low Dose Medication	Active comparator	Drug: Methylphenidate 0.15 mg/kg, Behavioral: High Intensity BMOD0.15 mg/kg MPH, High Intensity BMOD
High Intensity BMOD + Medium Dose Medication	Active comparator	Drug: Methylphenidate 0.3 mg/kg, Behavioral: High Intensity BMOD0.3 mg/kg MPH, High Intensity BMOD
High Intensity BMOD + Higher Dose Medication	Active comparator	Drug: Methylphenidate 0.6 mg/kg, Behavioral: High Intensity BMOD0.6 mg/kg MPH, High Intensity BMOD

Who may qualify

Ages: 5 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

Attention Deficit Hyperactivity Disorder
IQ >= 80

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Methylphenidate 0.15 mg/kg0.15 m/kg/dose immediate-release methylphenidate	Drug	High Intensity BMOD + Low Dose Medication, Low Dose Medication Only, Low Intensity BMOD + Low Dose Medication
Low-Intensity BMODLower-intensity behavioral treatment package.	Behavioural	Low Intensity BMOD + Higher Dose Medication, Low Intensity BMOD + Low Dose Medication, Low Intensity BMOD + Medium Dose Medication, Low Intensity BMOD Only
Methylphenidate 0.3 mg/kg0.3 mg/kg/dose immediate-release methylphenidate	Drug	High Intensity BMOD + Medium Dose Medication, Low Intensity BMOD + Medium Dose Medication, Medium Dose Medication Only
Placebo	Drug	Low Intensity BMOD Only, No Treatment
Methylphenidate 0.6 mg/kg0.3 mg/kg/dose immediate-release methylphenidate	Drug	High Intensity BMOD + Higher Dose Medication, Higher Dose Medication Only, Low Intensity BMOD + Higher Dose Medication
High Intensity BMODComprehensive high-intensity Summer Treatment Program (STP)	Behavioural	High Intensity BMOD + Higher Dose Medication, High Intensity BMOD + Low Dose Medication, High Intensity BMOD + Medium Dose Medication, High Intensity BMOD Only

Primary outcome

Social Behavior-Negative Verbalizations
Time frame: 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
Time frame: Daily for 45 days
Daily records of percentage of assigned problems completed by children in a 60-minute classroom period.

1 secondary outcome

Treatment Satisfaction
Time frame: End of Treatment

Results and safety

Results posted to the registry on 30 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Within-Subject Treatment	154	153

Primary outcome: Social Behavior-Negative Verbalizations

Time frame: Daily for 45 days. Mean (Standard Deviation). Unit: Number of Observed Behaviors

Measure	No Treatment n = 153	Low Dose Medication Only n = 153	Medium Dose Medication Only n = 153	Higher Dose Medication Only n = 153	Low Intensity BMOD Only n = 153	Low Intensity BMOD + Low Dose Medication n = 153	Low Intensity BMOD + Medium Dose Medication n = 153	Low Intensity BMOD + Higher Dose Medication n = 153	High Intensity BMOD Only n = 153	High Intensity BMOD + Low Dose Medication n = 153	High Intensity BMOD + Medium Dose Medication n = 153	High Intensity BMOD + Higher Dose Medication n = 153
Value	73.32 (127.11)	45.41 (85.23)	28.41 (59.11)	15.08 (29.61)	27.06 (45.77)	13.70 (27.99)	9.27 (20.05)	4.28 (9.91)	20.23 (41.13)	7.61 (19.21)	4.08 (8.59)	2.49 (7.50)

Primary outcome: Classroom Behavior

Time frame: Daily for 45 days. Mean (Standard Deviation). Unit: Percentage of Work Completed

Measure	No Treatment n = 153	Low Dose Medication Only n = 153	Medium Dose Medication Only n = 153	Higher Dose Medication Only n = 153	Low Intensity BMOD Only n = 153	Low Intensity BMOD + Low Dose Medication n = 153	Low Intensity BMOD + Medium Dose Medication n = 153	Low Intensity BMOD + Higher Dose Medication n = 153	High Intensity BMOD Only n = 153	High Intensity BMOD + Low Dose Medication n = 153	High Intensity BMOD + Medium Dose Medication n = 153	High Intensity BMOD + Higher Dose Medication n = 153
Value	37 (23)	53 (26)	57 (24)	61 (23)	53 (21)	67 (18)	72 (19)	75 (38)	58 (22)	72 (17)	75 (14)	76 (15)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Daily for 45 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 154 (0%)	3 of 153 (2%)	Not reported
Low Dose Medication	0 of 154 (0%)	2 of 153 (1.3%)	Not reported
Medium Dose Medication	0 of 154 (0%)	3 of 153 (2%)	Not reported
Higher Dose Medication	0 of 154 (0%)	17 of 153 (11.1%)	Not reported

Limitations and caveats (from the sponsor): Highly structured environment and direct observational measures were used. Additional study in natural school and home settings will be necessary.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundFabiano, 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.
Background: PubMed 24429997Pelham 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.
Center for Children and Families Home PageLink provided by the sponsor.
Individual participant dataSharing planned: Yes

Related trials for Attention Deficit Disorder With Hyperactivity

Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
RecruitingPhase 3
A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William E Pelham, PhD principal investigator

Professor, Florida International University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Social Behavior-Negative Verbalizations (time frame: Daily for 45 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00050622, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016.