Evidence map›Paper›PMID 27238065›Full record

Trial reportJournal of the American Academy of Child and Adolescent Psychiatry2016

Severely Aggressive Children Receiving Stimulant Medication Versus Stimulant and Risperidone: 12-Month Follow-Up of the TOSCA Trial.

Kenneth D Gadow, Nicole V Brown, L Eugene Arnold, Kristin A Buchan-Page, Oscar G Bukstein, Eric Butter, Cristan A Farmer, Robert L Findling, David J Kolko, Brooke S G Molina and 3 more

Registry-linked trialOpen access · greenAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Journal of the American Academy of Child and Adolescent Psychiatry, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00796302 (Stimulant and Risperidone in Children With Severe Physical Aggression), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
4.4field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00796302 phase4completednot on this map

Stimulant and Risperidone in Children With Severe Physical Aggression

TypeinterventionalSponsorMichael AmanRan2008 to 2012Enrolled168ConditionsAttention Deficit Disorder With HyperactivityArmsMethylphenidate HCl, Risperidone, Parent Management Training (PMT), Placebo
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 43 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
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  5. Trial
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  7. Trial
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Effectiveness of Stimulant Medications on Disruptive Behavior and Mood Problems in Young Children.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2020
    Article
  14. Clozapine in the Treatment of Aggression in Conduct Disorder in Children and Adolescents: A Randomized, Double-blind, Controlled Trial.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2019
    Article
  15. Article
  16. A Retrospective Study of Long Acting Risperidone Use to Support Treatment Adherence in Youth with Conduct Disorder.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2017
    Article
  17. Disruptive mood dysregulation disorder: current insights.Neuropsychiatric disease and treatment · 2016
    Review
  18. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 1 country.

Kenneth D GadowStony Brook University, Stony Brook, NY. Electronic address: kenneth.gadow@stonybrook.edu.
Nicole V BrownCenter for Biostatistics, Ohio State University, Columbus.
L Eugene ArnoldNisonger Center, Ohio State University.
Kristin A Buchan-PageNisonger Center, Ohio State University.
Oscar G BuksteinUniversity of Pittsburgh and is now with Boston Children's Hospital and Harvard Medical School.
Eric ButterNisonger Center, Ohio State University.
Cristan A FarmerNisonger Center and is now with Pediatrics and Developmental Neuroscience Branch, National Institute of Mental Health (NIMH), Bethesda, MD.
Robert L FindlingCase Western Reserve University, Cleveland, and is now with Johns Hopkins University, Kennedy Krieger Institute, Baltimore.
David J KolkoUniversity of Pittsburgh.
Brooke S G MolinaUniversity of Pittsburgh.
Robert R RiceNisonger Center, Ohio State University.
Jayne SchneiderStony Brook University, Stony Brook, NY.
Michael G AmanNisonger Center, Ohio State University.
The Ohio State University Wexner Medical Center · USStony Brook University · USUniversity of Pittsburgh · USHarvard University · USKennedy Krieger Institute · USNational Institute of Mental Health · USThe Ohio State University · US

Funding

UNIVERSITY OF PITTSBURGH CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE: BPCAUL1RR024153 · NCRR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2006 to 2011
$73.9M
University of Pittsburgh Clinical and Translational Science InstituteUL1TR000005 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2012 to 2015
$50.8M
The Ohio State University Center for clinical and Translational ScienceUL1TR001070 · NCATS · OHIO STATE UNIVERSITY · PI JACKSON, REBECCA D · 2013 to 2017
$22.6M
World Trade Center Worker and Volunteer Medical Screening ProgramM01RR010710 · NCRR · STATE UNIVERSITY NEW YORK STONY BROOK · PI BAHOU, WADIE F · 1998 to 2009
$17.6M
The Ohio State University Center for Clinical and Translational Science (UL1)UL1TR000090 · NCATS · OHIO STATE UNIVERSITY · PI JACKSON, REBECCA D · 2012 to 2013
$7.9M
1/4-Stimulant and Risperidone for Youth with Severe Physical AggressionR01MH077907 · NIMH · OHIO STATE UNIVERSITY · PI AMAN, MICHAEL GEORGE · 2008 to 2011
$1.9M
3/4-Stimulant and Risperidone for Youth with Severe Physical AggressionR01MH077750 · NIMH · CASE WESTERN RESERVE UNIVERSITY · PI MCNAMARA, NORA · 2008 to 2011
$1.6M
2/4-Stimulant and Risperidone for Youth with Severe Physical AggressionR01MH077676 · NIMH · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI MOLINA, BROOKE S.G. · 2008 to 2011
$1.6M
4/4-Stimulant and Risperidone for Youth with Severe Physical AggressionR01MH077997 · NIMH · STATE UNIVERSITY NEW YORK STONY BROOK · PI GADOW, KENNETH D · 2008 to 2011
$1.5M
NCATS NIH HHS UL1 TR000005NCATS NIH HHS UL1 TR000090NCATS NIH HHS UL1 TR001070NCRR NIH HHS M01 RR010710NCRR NIH HHS UL1 RR024153NIMH NIH HHS R01 MH077676NIMH NIH HHS R01 MH077750NIMH NIH HHS R01 MH077907NIMH NIH HHS R01 MH077997
6 · The paper itself

Abstract

objectiveThe objective of this study was to evaluate 52-week clinical outcomes of children with co-occurring attention-deficit/hyperactivity disorder (ADHD), disruptive behavior disorder, and serious physical aggression who participated in a prospective, longitudinal study that began with a controlled, 9-week clinical trial comparing the relative efficacy of parent training + stimulant medication + placebo (Basic; n = 84) versus parent training + stimulant + risperidone (Augmented; n = 84).

methodAlmost two-thirds (n = 108; 64%) of families in the 9-week study participated in week 52 follow-ups (Basic, n = 55; Augmented, n = 53) and were representative of the initial study sample. The assessment battery included caregiver and clinician ratings and laboratory tests.

resultsOnly 43% of participants in the Augmented group and 36% in the Basic group still adhered to their assigned regimen (not significant [NS]); 23% of those in the Augmented group and 11% in the Basic group were taking no medication (NS). Both randomized groups improved baseline to follow-up, but the 3 primary parent-reported behavioral outcomes showed no significant between-group differences. Exploratory analyses indicated that participants in the Augmented group (65%) were more likely (p = .02) to have a Clinical Global Impressions (CGI) severity score of 1 to 3 (i.e., normal to mildly ill) at follow-up than those in the Basic group (42%). Parents rated 45% of children as impaired often or very often from ADHD, noncompliant, or aggressive behavior. The Augmented group had elevated prolactin levels, and the Basic group had decreased weight over time. Findings were generally similar whether groups were defined by randomized assignment or follow-up treatment status.

conclusionBoth treatment strategies were associated with clinical improvement at follow-up, and primary behavioral outcomes did not differ significantly. Many children evidenced lingering mental health concerns, suggesting the need for additional research into more effective interventions. Clinical trial registration information-Treatment of Severe Childhood Aggression (the TOSCA Study); http://clinicaltrials.gov/; NCT00796302.

Indexed as

Outcome Assessment, Health CareAggressionAntipsychotic AgentsAttention Deficit and Disruptive Behavior DisordersCentral Nervous System StimulantsChildDrug SynergismDrug Therapy, CombinationFemaleFollow-Up StudiesHumansMaleRisperidoneAntipsychotic AgentsCentral Nervous System StimulantsRisperidoneADHDconduct disordermethylphenidateoppositional defiant disorderrisperidone

Identifiers

PMID27238065
PMCPMC4886346
OpenAlexW2340054991

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.