Kenneth D Gadow1, Nicole V Brown2, L Eugene Arnold3, Kristin A Buchan-Page3, Oscar G Bukstein4, Eric Butter3, Cristan A Farmer5, Robert L Findling6, David J Kolko7, Brooke S G Molina7, Robert R Rice3, Jayne Schneider8, Michael G Aman3. 1. Stony Brook University, Stony Brook, NY. Electronic address: kenneth.gadow@stonybrook.edu. 2. Center for Biostatistics, Ohio State University, Columbus. 3. Nisonger Center, Ohio State University. 4. University of Pittsburgh and is now with Boston Children's Hospital and Harvard Medical School. 5. Nisonger Center and is now with Pediatrics and Developmental Neuroscience Branch, National Institute of Mental Health (NIMH), Bethesda, MD. 6. Case Western Reserve University, Cleveland, and is now with Johns Hopkins University, Kennedy Krieger Institute, Baltimore. 7. University of Pittsburgh. 8. Stony Brook University, Stony Brook, NY.
Abstract
OBJECTIVE: The 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). METHOD: Almost 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. RESULTS: Only 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. CONCLUSION: Both 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. Published by Elsevier Inc.
RCT Entities:
OBJECTIVE: The 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). METHOD: Almost 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. RESULTS: Only 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. CONCLUSION: Both 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. Published by Elsevier Inc.
Authors: Kenneth D Gadow; L Eugene Arnold; Brooke S G Molina; Robert L Findling; Oscar G Bukstein; Nicole V Brown; Nora K McNamara; E Victoria Rundberg-Rivera; Xiaobai Li; Heidi L Kipp; Jayne Schneider; Cristan A Farmer; Jennifer L Baker; Joyce Sprafkin; Robert R Rice; Srihari S Bangalore; Eric M Butter; Kristin A Buchan-Page; Elizabeth A Hurt; Adrienne B Austin; Sabrina N Grondhuis; Michael G Aman Journal: J Am Acad Child Adolesc Psychiatry Date: 2014-06-12 Impact factor: 8.829
Authors: Daniel F Connor; Stephen J Glatt; Ivan D Lopez; Denise Jackson; Richard H Melloni Journal: J Am Acad Child Adolesc Psychiatry Date: 2002-03 Impact factor: 8.829
Authors: Elizabeth Pappadopulos; James C Macintyre Ii; M Lynn Crismon; Robert L Findling; Richard P Malone; Albert Derivan; Nina Schooler; Lin Sikich; Laurence Greenhill; Sarah B Schur; Chip J Felton; Harvey Kranzler; David M Rube; Jeffrey Sverd; Molly Finnerty; Scott Ketner; Sonja E Siennick; Peter S Jensen Journal: J Am Acad Child Adolesc Psychiatry Date: 2003-02 Impact factor: 8.829
Authors: Michael G Aman; Oscar G Bukstein; Kenneth D Gadow; L Eugene Arnold; Brooke S G Molina; Nora K McNamara; E Victoria Rundberg-Rivera; Xiaobai Li; Heidi Kipp; Jayne Schneider; Eric M Butter; Jennifer Baker; Joyce Sprafkin; Robert R Rice; Srihari S Bangalore; Cristan A Farmer; Adrienne B Austin; Kristin A Buchan-Page; Nicole V Brown; Elizabeth A Hurt; Sabrina N Grondhuis; Robert L Findling Journal: J Am Acad Child Adolesc Psychiatry Date: 2013-11-18 Impact factor: 8.829
Authors: Cristan A Farmer; L Eugene Arnold; Oscar G Bukstein; Robert L Findling; Kenneth D Gadow; Xiaobai Li; Eric M Butter; Michael G Aman Journal: Child Adolesc Psychiatry Ment Health Date: 2011-11-10 Impact factor: 3.033
Authors: Justin A Barterian; L Eugene Arnold; Nicole V Brown; Cristan A Farmer; Craig Williams; Robert L Findling; David J Kolko; Oscar G Bukstein; Brooke S G Molina; Lisa Townsend; Michael G Aman Journal: J Am Acad Child Adolesc Psychiatry Date: 2017-10-06 Impact factor: 8.829
Authors: Robert L Findling; Lisa Townsend; Nicole V Brown; L Eugene Arnold; Kenneth D Gadow; David J Kolko; Nora K McNamara; Devin S Gary; Dana B Kaplin; Cristan A Farmer; Heidi Kipp; Craig Williams; Eric M Butter; Oscar G Bukstein; Robert Rice; Kristin Buchan-Page; Brooke S G Molina; Michael G Aman Journal: J Child Adolesc Psychopharmacol Date: 2017-02 Impact factor: 2.576
Authors: Sabrina N Grondhuis; Cristan A Farmer; L Eugene Arnold; Kenneth D Gadow; Robert L Findling; Brooke S G Molina; David J Kolko; Kristin A Buchan-Page; Robert R Rice; Eric M Butter; Michael G Aman Journal: J Child Adolesc Psychopharmacol Date: 2019-11-15 Impact factor: 2.576
Authors: Heather M Joseph; Cristan Farmer; Heidi Kipp; David Kolko; Michael Aman; James McGinley; L Eugene Arnold; Kenneth D Gadow; Robert L Findling; Brooke S G Molina Journal: J Child Adolesc Psychopharmacol Date: 2018-12-28 Impact factor: 2.576
Authors: R Taurines; S Fekete; A Preuss-Wiedenhoff; A Warnke; C Wewetzer; P Plener; R Burger; M Gerlach; M Romanos; K M Egberts Journal: J Neural Transm (Vienna) Date: 2022-03-18 Impact factor: 3.850