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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH080791 | U.S. NIH Grant/Contract | View source | |
| DDTR B2-NDH |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Participants will receive stimulant medication therapy and referrals to community-based psychosocial treatments. |
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| 2 | Experimental | Participants will receive stimulant medication therapy and group-based behavior therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group-based behavior therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 at week 12 (endpoint) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James G. Waxmonsky, MD | Florida International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Children and Families at Florida International University | Miami | Florida | 33199 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26903253 | Derived | 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. |
| Label | URL |
|---|---|
| Click here for more information on this study at the Center for Children and Families at State University of New York at Buffalo | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Stimulant medication therapy | Drug | All participants will be stabilized on an FDA-approved stimulant medication for 2 to 6 weeks prior to therapy assignment. |
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| Community-based psychosocial treatment | Behavioral | Participants will receive referrals to community-based psychosocial treatments that will focus on ADHD symptoms and management of aggression. |
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| 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 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 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) | week 12 (endpoint) |
| FG001 | 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. |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| 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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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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). | 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. | Posted | Mean | Standard Deviation | units on a scale | Measured at weeks 12 (endpoint) |
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| 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 | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | measured at week 12 (endpoint) |
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| Secondary | 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 | 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. | Posted | Mean | Standard Deviation | units on a scale | Measured at Week12 (endpoint) |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Measured at Week 12 (endpoint) |
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| Secondary | 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) | 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. | Posted | Mean | Standard Deviation | units on a scale | week 12 (endpoint) |
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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.
Pittsburgh side effect rating scale given at every assessment point to assess medication related side effects. It lists 13 common (appetite loss, insomnia) and rare (hallucinations) adverse events associated with stimulants on a 0-3 likert with 3 being severe.
The suicide item from the CDRS was used to systematically measure suicidal ideation.
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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 | 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. | 1 | 30 | 16 | 30 | ||
| EG001 | 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. | 4 | 35 | 20 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| asthma exacerbation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | subject was admitted to hospital due to worsening of asthma. The child was discharged the next day at baseline health. Therapy treatment had ended 3 weeks prior but participant was on study medication which was deemed unrelated to the event. |
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| threat of self injurious behavior | Psychiatric disorders | Non-systematic Assessment | Control who became upset at school when asked to do work and picked up scissors and threatened(but did not attempt) to cut his hand. He was sent for emergency psychiatric assessment. He was discharged home that day at his baseline mental status. |
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| appendix removed | Gastrointestinal disorders | Non-systematic Assessment | Therapy subject hospitalized for appendicitis. he had appendix removed and discharged home 48hrs later with no sequelae. |
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| aggression towards other | Psychiatric disorders | Non-systematic Assessment | Therapy subject with history of aggression who became physically aggressive towards another student and then a teacher. She was hospitalized for 48hrs. No psychotropic medication was started and she was discharged at baseline mental status. |
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| expresssed suicial ideation | Psychiatric disorders | Systematic Assessment | Therapy subject who expressed suicidal ideation at school but made no attempt. He was hospitalized, diagnosed with pervasive developmental disorder traits & anxiety disorder. He was started on exclusionary medication so was discontinued from study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| worried/anxious | Psychiatric disorders | Systematic Assessment | measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant |
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| picking at skin, fingers, nails, lips | Skin and subcutaneous tissue disorders | Systematic Assessment | measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant |
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| repetitive movements/motor tics | Nervous system disorders | Systematic Assessment | measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant |
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| dull/tired | General disorders | Systematic Assessment | measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant |
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| stomachaches | Gastrointestinal disorders | Systematic Assessment | measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant |
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| crabby or irritable | Psychiatric disorders | Systematic Assessment | measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant |
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| loss of appetite | General disorders | Systematic Assessment | measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant |
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| insomnia | General disorders | Systematic Assessment | measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant |
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| tearful/sad affect | Psychiatric disorders | Systematic Assessment | measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant. |
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| dull or tired looking | Psychiatric disorders | Systematic Assessment | measured on the Pittsburgh Side effect rating scale which lists the most common (as well as rare ) adverse events seen with stimulant medications; each is rated on 0-3 with 0-none 3= severe. items rated 2 or more are considered clinically relevant |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James G Waxmonsky | Florida International University | 305 348 3258 | jwaxmons@fiu.edu |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
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| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| >=65 years |
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| Male |
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| OG001 | 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. |
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