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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Florida International University
ClinicalTrials.gov Identifier:
NCT00632619
First received: March 7, 2008
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
Results First Received: August 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Attention Deficit Disorder With Hyperactivity
Interventions: Behavioral: Group-based behavior therapy
Drug: Stimulant medication therapy
Behavioral: Community-based psychosocial treatment

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited as two cohorts- 50% in each wave. Wave one was recruited in Buffalo NY in the summer of 2009, from referrals from local pediatricians and therapists and mailings to families. The study was then moved to Florida International University where the second cohort was recruited from 9/10 to 12/10 using similar procedures.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were assessed at intake on the current ADHD medication regimen to make sure that they needed additional treatment beyond what they were currently receiving. There was no washout prior to enrollment.

Reporting Groups
  Description
Medication and Community Treatment Group

Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.

Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.

Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression.
Medication and Novel Therapy Group

Participants will receive stimulant medication therapy and group-based behavior therapy.

Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.

Group-based behavior therapy : 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.

Participant Flow:   Overall Study
    Medication and Community Treatment Group     Medication and Novel Therapy Group  
STARTED     33 [1]   35 [1]
COMPLETED     25 [2]   31 [2]
NOT COMPLETED     8     4  
[1] first cohort started 9/11/09 second cohort started 12/7/11
[2]
  1. st cohort completed follow up by 5/24/10
  2. nd cohort completed follow up 7/18/11



  Baseline Characteristics
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Reporting Groups
  Description
Medication and Community Treatment Group

Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments.

Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.

Community-based psychosocial treatment : Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression.
Medication and Novel Therapy Group

Participants will receive stimulant medication therapy and group-based behavior therapy.

Stimulant medication therapy : All participants will be stabilized on an FDA-approved stimulant medication for 4 to 8 weeks prior to therapy assignment.

Group-based behavior therapy : 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.
Total Total of all reporting groups

Baseline Measures
    Medication and Community Treatment Group     Medication and Novel Therapy Group     Total  
Number of Participants  
[units: participants]
 		  33     35     68  
Age  
[units: participants]
 		     
<=18 years     33     35     68  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  9.4  ± 1.5     9.3  ± 1.6     9.3  ± 1.5  
Gender  
[units: participants]
 		     
Female     7     11     18  
Male     26     24     50  
Region of Enrollment  
[units: participants]
 		     
United States     33     35     68  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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) ]
  Show Outcome Measure 1

2.  Secondary:   Young Mania Rating Scale (YMRS) Score   [ Time Frame: Measured at weeks 12 (endpoint) ]
  Show Outcome Measure 2

3.  Secondary:   Disruptive Behavior Disorder Scale Score for ADHD Symptoms   [ Time Frame: Measured at Week12 (endpoint) ]
  Show Outcome Measure 3

4.  Secondary:   Children's Depression Rating Scale-Revised (CDRS-R) Total Score   [ Time Frame: Measured at Week 12 (endpoint) ]
  Show Outcome Measure 4

5.  Secondary:   Disruptive Behavior Disorder Scale Score for ODD Symptoms   [ Time Frame: week 12 (endpoint) ]
  Show Outcome Measure 5


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.  


Results Point of Contact:  
Name/Title: James G Waxmonsky
Organization: Florida International University
phone: 305 348 3258
e-mail: jwaxmons@fiu.edu


No publications provided


Responsible Party: Florida International University
ClinicalTrials.gov Identifier: NCT00632619     History of Changes
Other Study ID Numbers: R34 MH080791, R34MH080791, DDTR B2-NDH
Study First Received: March 7, 2008
Results First Received: August 29, 2012
Last Updated: April 12, 2013
Health Authority: United States: Federal Government