Attention Deficit Disorder With HyperactivityNCT00632619

Group-Based Behavioral Therapy Combined With Stimulant Medication for Treating Children With Attention Deficit Hyperactivity Disorder and Impaired Mood

A study testing Group-based behavior therapy, Stimulant medication therapy and Community-based psychosocial treatment in people with Attention Deficit Disorder With Hyperactivity, run by Florida International University at 1 site 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

This study will evaluate the effectiveness of an integrative group psychosocial therapy combined with stimulant medication in treating children with attention deficit hyperactivity disorder plus impairments in mood. Read more about this study

Who is it for?: Ages 7 to 11 years
Conditions the study is for: Attention Deficit Disorder With Hyperactivity
What is being tested?: Group-based behavior therapy, Stimulant medication therapy and Community-based psychosocial treatment
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 1 siteUnited States
Study dates: Mar 2009to Sep 2011
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 7 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

ADHD combined subtype with evidence of depressive or manic-like symptoms, as assessed by CDRS, YMRS, and Washington University in St. Louis Kiddie Schedule for Affective Disorders and Schizophrenia, that persist after stimulant treatment

Who cannot join

Full Scale IQ less than 80
Current seizure disorder or history of seizures requiring treatment or other significant neurological problems
History of other medical problems for which stimulant treatment may involve considerable risk, including cardiac arrhythmias, hypertension, Tourette's disorder, or history of severe tic exacerbations caused by stimulant exposure (Note: child with uncomplicated tic disorders or a family history of tic disorders will not be excluded as stimulants are well tolerated in a majority of such cases)
Meets full criteria for Type I or II bipolar disorder or any child manifesting mood symptoms (manic or depressive), such as significant suicidal ideation or psychotic symptoms that require emergent pharmacological treatment or hospitalization
History or concurrent diagnosis of any of the following disorders: pervasive developmental disorder, schizophrenia or other psychotic disorders, post-traumatic stress disorder, sexual disorders, organic mental disorder, or eating disorder
No longer manifests impairing manic/depressive symptoms after stimulant therapy based on CDRS-R greater than 27 or YMRS greater than 11 with Clinical Global Impressions-Severity 3 or greater

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for Children and Families at Florida International University
Miami, Florida, 33199

Other trials in United States

About this study

Official title: A Novel Multimodal Intervention for Children With ADHD and Impaired Mood

Read the detailed description

There has been increasing recognition that many children with attention deficit hyperactivity disorder (ADHD) exhibit depressive and manic-like symptoms suggestive of major depressive disorder (MDD) and bipolar disorder (BP). Many children with ADHD plus impairments in mood display symptoms of irritability, affective instability, and reactive aggression, but they typically lack the hallmark symptoms, such as extreme mood cycles and sustained depressed mood, that lead to a BD or MDD diagnosis. Significant debate exists as to whether these children have a true comorbid mood disorder, making treatment of mood symptoms in ADHD children controversial. ADHD is traditionally treated with stimulant medications and/or behavior modification therapy. However, little is known about the safety of stimulants in ADHD children with manic symptoms. Also, no treatments exist that are designed to simultaneously improve both ADHD and mood problems in children. Psychosocial treatments hold particular promise for ADHD children with impairments in mood because they are well-studied pediatric treatments with little risk of worsening mood symptoms. This study will develop an integrative psychosocial treatment that includes aspects of cognitive behavioral therapy (CBT) and psychoeducational techniques for pediatric and adult mood disorders. The study will then evaluate the effectiveness of the integrative psychosocial treatment, called group behavior therapy, combined with stimulant medication in improving moods and enhancing treatment responses in children with ADHD and impairments in mood.

Participation in the study will last between 5 and 6 months. All eligible participants will begin treatment with stimulant medications for 2 to 6 weeks, or until an optimal medication dosage has been determined. During this medication dosing phase, study staff will collect weekly ratings of the child participant's behavior at home and school, and participants will be seen weekly by study doctors to monitor medication dosage. Upon achieving an optimal dose, child participants will answer questions about their mood and behavior.

Participants who are still exhibiting mood problems will then be assigned randomly to receive 12 weeks of either group behavior therapy or community-based psychosocial treatment, while still continuing on their prescribed medications. Group behavior therapy sessions for child participants will focus on improving mood and ability to maintain friendships, practicing ways to better control emotions, and learning effective problem solving skills. Child participants will also be given weekly homework assignments to practice learned therapy skills. Group behavior therapy sessions for parent participants will teach parents ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems. Participants assigned to community-based psychosocial treatment will not receive any counseling services as part of the study, but they will be referred to community services.

Every 6 weeks during the therapy phase, all participants will answer repeat questions about their mood and behavior. Six weeks after completing the therapy phase, participants will return for a final follow-up visit, which will include repeat questions, rating of the child participant's mood and symptoms, and meeting with a study doctor to check medications.

Conditions: Attention Deficit Disorder With Hyperactivity
Being tested: Group-based behavior therapy, Stimulant medication therapy, Community-based psychosocial treatment
Keywords: Subthreshold Manic States in Children, ADHD
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.

Group-based behavior therapyBehavioural
Group-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems.
Stimulant medication therapyDrug
All participants will be stabilized on an FDA-approved stimulant medication for 2 to 6 weeks prior to therapy assignment.
Community-based psychosocial treatmentBehavioural
Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression.

Study groups in NCT00632619
Study group	Role	What they receive
1	Active comparator	Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments. Receives: Drug: Stimulant medication therapy; Behavioral: Community-based psychosocial treatment
2	Experimental	Participants will receive stimulant medication therapy and group-based behavior therapy. Receives: Behavioral: Group-based behavior therapy; Drug: Stimulant medication therapy

What is being measured

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

Mood Severity Index Measures Severity of Mood Symptoms (MSI).Range of 0-116; Clinicians Give to Parents and Child to Get Composite Score; Higher Scores=Greater Severity; 0-10=no Symptoms, 11-20=Mild Symptoms, 21to 35 =Moderate Symptoms and >35 is Severe
averaged Composite of endpoint ratings from the Children's Depression Rating Scale (CDRS used to measure depressive symptoms) and Young mania rating scale (MRS used to measure manic like symptoms) that has been used before as primary outcome in treatment studies of children with a mixture of affective symptoms (Fristad, et al., 2009). Prior to commencement of data collection, we elected to use it as the primary mood measure for the therapy phase of the trial over the initially selected YMRS as subjects either had to have elevations on the YMRS or CDRS but not necessarily both to be eligible. Hence, some subjects had very low YMRS scores at baseline which is why we chose the MSI over the YMRS.
Measured: measured at week 12 (endpoint)

Secondary outcomes (4)

Young Mania Rating Scale (YMRS) Score
rates manic like symptoms in children; 7 items ranging from 0-4 and 4 items on a 0-8 scale; higher scores indicate more severe symptom severity (min total score=0, max=60). There are no subscales. Symptom severity information is obtained from direct interview of parent and child. It was initially selected as the primary outcome but prior to commencement of data collection the Mood Severity Index (MSI) was chosen instead based on recently published work in a related study (see above).
Measured: Measured at weeks 12 (endpoint)
Disruptive Behavior Disorder Scale Score for ADHD Symptoms
sum of severity rating for all 18 DSM (Diagnostic and Statistics Manual for Mental Disorders) IV ADHD symptoms and two from DSM 3R on a 0 to 3 scale obtained from parent rating; range is from 0 to 60 with higher numbers indicating more severe symptoms
Measured: Measured at Week12 (endpoint)
Children's Depression Rating Scale-Revised (CDRS-R) Total Score
rates 17 items of depression on a severity scale using information obtained from parent and child. Higher numbers indicate more severity symptoms and range is from 17 to 113.
Measured: Measured at Week 12 (endpoint)
Disruptive Behavior Disorder Scale Score for ODD Symptoms
parents rating all DSM symptoms of Oppositional Defiant Disorder on a 0-3 severity scale with higher scores indicating more severe symptoms and range is from 0-27 (8 DSM IV items and I item from DSM 3R)
Measured: week 12 (endpoint)

Timeline

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

Mar 2009Sep 2011

First posted11 Mar 2008 (estimated)
Study startMar 2009
Primary completionJun 2011
Study completionSep 2011

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 (1)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: Parallel groups
Masking: None (open label)
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00632619
Sponsor's protocol ID: R34MH080791
Other IDs: R34MH080791, DDTR B2-NDH
Status last verified: Apr 2013
First submitted: 7 Mar 2008
Last updated: 21 May 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Waxmonsky JG, Waschbusch DA, Belin P, Li T, Babocsai L, Humphery H, Pariseau ME, Babinski DE, Hoffman MT, Haak JL, Mazzant JR, Fabiano GA, Pettit JW, Fallahazad N, Pelham WE. A Randomized Clinical Trial of an Integrative Group Therapy for Children With Severe Mood Dysregulation. J Am Acad Child Adolesc Psychiatry. 2016 Mar;55(3):196-207. doi: 10.1016/j.jaac.2015.12.011. Epub 2015 Dec 28.
PubMed 26903253

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

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All Attention Deficit Disorder With Hyperactivity trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Novel Multimodal Intervention for Children With ADHD and Impaired Mood
ClinicalTrials.gov ID: NCT00632619
Acronym / sponsor ID: R34MH080791
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Subthreshold Manic States in Children, ADHD
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Florida International UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Mar 2009
Primary completion: Jun 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 11 Mar 2008 (estimated)
Results: Posted 21 May 2013

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: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: Stimulant medication therapy, Behavioral: Community-based psychosocial treatmentParticipants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.
2	Experimental	Behavioral: Group-based behavior therapy, Drug: Stimulant medication therapyParticipants will receive stimulant medication therapy and group-based behavior therapy.

Who may qualify

Ages: 7 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

ADHD combined subtype with evidence of depressive or manic-like symptoms, as assessed by CDRS, YMRS, and Washington University in St. Louis Kiddie Schedule for Affective Disorders and Schizophrenia, that persist after stimulant treatment

Key exclusion criteria (6 listed)

Full Scale IQ less than 80
Current seizure disorder or history of seizures requiring treatment or other significant neurological problems
History of other medical problems for which stimulant treatment may involve considerable risk, including cardiac arrhythmias, hypertension, Tourette's disorder, or history of severe tic exacerbations caused by stimulant exposure (Note: child with uncomplicated tic disorders or a family history of tic disorders will not be excluded as stimulants are well tolerated in a majority of such cases)
Meets full criteria for Type I or II bipolar disorder or any child manifesting mood symptoms (manic or depressive), such as significant suicidal ideation or psychotic symptoms that require emergent pharmacological treatment or hospitalization
History or concurrent diagnosis of any of the following disorders: pervasive developmental disorder, schizophrenia or other psychotic disorders, post-traumatic stress disorder, sexual disorders, 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
Group-based behavior therapyGroup-based behavior therapy with a parenting class will include 12 weeks of sessions that focus on reducing oppositional and aggressive behaviors. Children will participate in 12 weeks of social skills training integrated with a cognitive behavioral therapy (CBT) component to target mood symptoms. Parents will learn ways to identify and address their child's mood problems, communicate better with their child, and work with school staff to address academic and behavioral problems.	Behavioural	2
Stimulant medication therapyAll participants will be stabilized on an FDA-approved stimulant medication for 2 to 6 weeks prior to therapy assignment.	Drug	1, 2
Community-based psychosocial treatmentParticipants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression.	Behavioural	1

Primary outcome

Mood Severity Index Measures Severity of Mood Symptoms (MSI).Range of 0-116; Clinicians Give to Parents and Child to Get Composite Score; Higher Scores=Greater Severity; 0-10=no Symptoms, 11-20=Mild Symptoms, 21to 35 =Moderate Symptoms and >35 is Severe
Time frame: measured at week 12 (endpoint)
averaged Composite of endpoint ratings from the Children's Depression Rating Scale (CDRS used to measure depressive symptoms) and Young mania rating scale (MRS used to measure manic like symptoms) that has been used before as primary outcome in treatment studies of children with a mixture of affective symptoms (Fristad, et al., 2009). Prior to commencement of data collection, we elected to use it as the primary mood measure for the therapy phase of the trial over the initially selected YMRS as subjects either had to have elevations on the YMRS or CDRS but not necessarily both to be eligible. Hence, some subjects had very low YMRS scores at baseline which is why we chose the MSI over the YMRS.

4 secondary outcomes

Young Mania Rating Scale (YMRS) Score
Time frame: Measured at weeks 12 (endpoint)
Disruptive Behavior Disorder Scale Score for ADHD Symptoms
Time frame: Measured at Week12 (endpoint)
Children's Depression Rating Scale-Revised (CDRS-R) Total Score
Time frame: Measured at Week 12 (endpoint)
Disruptive Behavior Disorder Scale Score for ODD Symptoms
Time frame: week 12 (endpoint)

Results and safety

Results posted to the registry on 21 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Medication and Community Treatment Group	33	25
Medication and Novel Therapy Group	35	31

Primary outcome: Mood Severity Index Measures Severity of Mood Symptoms (MSI).Range of 0-116; Clinicians Give to Parents and Child to Get Composite Score; Higher Scores=Greater Severity; 0-10=no Symptoms, 11-20=Mild Symptoms, 21to 35 =Moderate Symptoms and >35 is Severe

Time frame: measured at week 12 (endpoint). Mean (Standard Deviation). Unit: units on a scale

Measure	Medication and Community Treatment Group n = 25	Medication and Novel Therapy Group n = 31
Value	17.33 (7.29)	13.82 (6.03)

Medication and Community Treatment Group vs Medication and Novel Therapy Group: p = 0.015, ANOVA

Population analysed: all subjects who were successfully stabilized on stimulant medication and then entered therapy phase; subjects not able to tolerate stimulant med for ADHD or whose mood symptoms resolved with optimization of their stimulant dose were not included in the therapy phase.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: for two years- from first subject enrolling in summer of 2009 to last follow up assessment done summer of 2011. Three controls dropped prior to any study treatments so they are not included in the adverse event analysis which is why the N is 30 not 33.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Medication and Community Treatment Group	1 of 30 (3.3%)	16 of 30 (53.3%)	Not reported
Medication and Novel Therapy Group	4 of 35 (11.4%)	20 of 35 (57.1%)	Not reported

Limitations and caveats (from the sponsor): relatively small sample size, the lack of a gold standard measurement for mood dysregulation in children, run at a specialty mental health research center and therapy subjects had more contact with study staff which may have impacted results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26903253Waxmonsky JG, Waschbusch DA, Belin P, Li T, Babocsai L, Humphery H, Pariseau ME, Babinski DE, Hoffman MT, Haak JL, Mazzant JR, Fabiano GA, Pettit JW, Fallahazad N, Pelham WE. A Randomized Clinical Trial of an Integrative Group Therapy for Children With Severe Mood Dysregulation. J Am Acad Child Adolesc Psychiatry. 2016 Mar;55(3):196-207. doi: 10.1016/j.jaac.2015.12.011. Epub 2015 Dec 28.
Click here for more information on this study at the Center for Children and Families at State University of New York at BuffaloLink provided by the sponsor.

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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.

James G. Waxmonsky, MD principal investigator

Florida International University

1 site 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 1 inclusion and 6 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 21 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 21 May 2013). 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?

Mood Severity Index Measures Severity of Mood Symptoms (MSI).Range of 0-116; Clinicians Give to Parents and Child to Get Composite Score; Higher Scores=Greater Severity; 0-10=no Symptoms, 11-20=Mild Symptoms, 21to 35 =Moderate Symptoms and >35 is Severe (time frame: measured at week 12 (endpoint)). 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 NCT00632619, which also lists 1 linked publication.

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 21 May 2013; AzTrials last refreshed its copy on 1 Nov 2026.