Evidence map›Paper›PMID 25885012›Full record

Trial reportJournal of child and adolescent psychopharmacology2015

Participant satisfaction in a study of stimulant, parent training, and risperidone in children with severe physical aggression.

E Victoria Rundberg-Rivera, Lisa D Townsend, Jayne Schneider, Cristan A Farmer, Brooke B S G Molina, Robert L Findling, Kenneth D Gadow, Oscar G Bukstein, L Eugene Arnold, David J Kolko and 7 more

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of child and adolescent psychopharmacology, 2015. 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 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. 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

17 authors.

E Victoria Rundberg-Rivera1 Department of Psychiatry, Stony Brook University School of Medicine , Stony Brook, New York.
Lisa D Townsend
Jayne Schneider
Cristan A Farmer
Brooke B S G Molina
Robert L Findling
Kenneth D Gadow
Oscar G Bukstein
L Eugene Arnold
David J Kolko
Kristin A Buchan-Page
Nora K McNamara
Chenel Michel
Adrienne Austin
Heidi Kipp
Robert R Rice
Michael G Aman

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 GOLDSTEIN, RITA Z · 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 8UL1TR000090-05NCATS NIH HHS UL1TR000005NCATS NIH HHS UL1 TR001070NCRR NIH HHS M01RR10710NCRR NIH HHS UL1 RR024153NIMH NIH HHS R01 MH077676NIMH NIH HHS R01 MH077750NIMH NIH HHS R01 MH077907NIMH NIH HHS R01 MH 077997
6 · The paper itself

Abstract

objectiveThe purpose of this study was to examine the satisfaction of families who participated in the Treatment of Severe Childhood Aggression (TOSCA) study.

methodsTOSCA was a randomized clinical trial of psychostimulant plus parent training plus placebo (basic treatment) versus psychostimulant plus parent training plus risperidone (augmented treatment) for children with severe physical aggression, disruptive behavior disorder, and attention-deficit/hyperactivity disorder. Parents completed a standardized Parent Satisfaction Questionnaire (PSQ).

resultsOf the 168 families randomized, 150 (89.3%) provided consumer satisfaction data. When they were asked if they would join the study again if they had the option to repeat, 136 (91%) said "yes," 11 (7%) said "maybe," and one (<1%) said "no." When asked if they would recommend the study to other parents with children having similar problems, 147 (98%) said "yes" and 3 (2%) said "maybe." Between 71% (rating one aspect of the Parent Training) and 96% (regarding the diagnostic interview) endorsed study procedures using the most positive response option. Asked if there were certain aspects of the study that they especially liked, 64 (43%) spontaneously reported parent training. Treatment assignment (basic vs. augmented) and responder status were not associated with reported satisfaction. However, responder status was strongly associated with parent confidence in managing present (p<0.001) and future (p<0.005) problem behaviors.

conclusionsThese findings indicate high levels of satisfaction with TOSCA study involvement and, taken together with previous pediatric psychopharmacology social validity studies, suggest high levels of support for the research experience. These findings may inform research bioethics and may have implications for deliberations of institutional review boards. TRIAL REGISTRY: Treatment of Severe Childhood Aggression (The TOSCA Study), NCT00796302, clinicaltrials.gov .

Indexed as

AggressionAntipsychotic AgentsAttention Deficit and Disruptive Behavior DisordersAttention Deficit Disorder with HyperactivityCentral Nervous System StimulantsChildDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleParentsPatient SatisfactionRisperidoneSeverity of Illness IndexSurveys and QuestionnairesAntipsychotic AgentsCentral Nervous System StimulantsRisperidone

Identifiers

PMID25885012
PMCPMC4403019

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.