The treatment of severe child aggression (TOSCA) study: Design challenges

Child and Adolescent Psychiatry and Mental Health

Volumn 5, Issue , 2011, Pages

  Farmer, Cristan A ^a   Arnold, L Eugene ^a   Bukstein, Oscar G ^b   Findling, Robert L ^c   Gadow, Kenneth D ^d   Li, Xiaobai ^e   Butter, Eric M ^a   Aman, Michael G ^a  

^a THE OHIO STATE UNIVERSITY WEXNER MEDICAL CENTER   (United States)

^b UNIVERSITY OF PITTSBURGH   (United States)

^c CASE WESTERN RESERVE UNIVERSITY   (United States)

^d STONY BROOK UNIVERSITY   (United States)

^e OHIO STATE UNIVERSITY   (United States)

Author keywords

Adhd; Disruptive behavior disorder; Drug trial; Risperidone; Stimulant

Indexed keywords

ARIPIPRAZOLE; CLONIDINE; GUANFACINE; METHYLPHENIDATE; OLANZAPINE; QUETIAPINE; RISPERIDONE;

AGGRESSION; ARTICLE; ATTENTION DEFICIT DISORDER; BEHAVIOR DISORDER; CHILDHOOD DISEASE; DECREASED APPETITE; DRUG EFFICACY; DRUG SAFETY; HUMAN; INCREASED APPETITE; POLYPHARMACY; PRIORITY JOURNAL; PSYCHOPHARMACOLOGY; PSYCHOTHERAPY; SEDATION; STUDY DESIGN; TREATMENT OUTCOME;

EID: 80755143002     PISSN: None     EISSN: 17532000     Source Type: Journal    
DOI: 10.1186/1753-2000-5-36     Document Type: Article

References (68)

1. Angold A, Costello E, Erkanli A. Comorbidity. J Child Psychol Psyc 1999, 40:57-87.
2. Kazdin A, Weisz J. Identifying and developing empirically supported child and adolescent treatments. J Consult Clin Psych 1998, 66:19-36.
3. Nock M. Progress review of the psychosocial treatment of child conduct problems. Clin Psychol - Sci Pr 2003, 10:1-28.
4. Serketich W, Dumas J. The effectiveness of behavioral training to modify antisocial behavior in children: a meta-analysis. Behav Ther 1996, 27:171-186.
5. Connor D, Carlson G, Chang K, Daniolos P, Ferziger R, Findling R, Hutchinson J, Malone R, Halperin J, Plattner B, Post R, Reynolds D, Rogers K, Saxena K, Steiner H. Juvenile maladaptive aggression: A review of prevention, treatment, and service configuration and a proposed research agenda. J Clin Psychiatry 2006, 67:808-820. 10.4088/JCP.v67n0516, 16841631.
6. Carlson C, Pelham W, Milich R, Dixon J. Single and combined effects of methylphenidate and behavior therapy on the classroom performance of children with attention-deficit hyperactivity disorder. J Abnorm Child Psych 1992, 20:213-232.
7. Jensen PS, Hinshaw SP, Kraemer HC, Lenora N, Newcorn JH, Abikoff HB, March JS, Arnold LE, Cantwell DP, Conners CK, Elliott GR, Greenhill LL, Hechtman L, Hoza B, Pelham WE, Severe JB, Swanson JM, Wells KC, Vitiello B, Wigal T. ADHD Comorbidity Findings From the MTA Study: Comparing Comorbid Subgroups. J Am Acad Child Psy 2001, 40:147-158.
8. The MTA Cooperative Group A 14-Month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder. Arch Gen Psychiat 1999, 56:1073-1086. 10.1001/archpsyc.56.12.1073, 10591283, The MTA Cooperative Group.
9. Swanson JM, Kraemer HC, Hinshaw SP, Arnold LE, Conners CK, Abikoff HB, Clevenger W, Davies M, Elliott G, Greenhill LL, Hechtman L, Hoza B, Jensen PS, March JS, Newcorn JH, Owens L, Pelham WE, Schiller E, Severe J, Simpson S, Vitiello B, Wells CK, Wigal T, Wu M. Clinical Relevance of the Primary Findings of the MTA: Success Rates Based on Severity of ADHD and ODD Symptoms at the End of Treatment. J Am Acad Child Psy 2001, 40:168-179.
10. Campbell S, Spieker S, Vandergrift N, Belsky J, Burchinal M. Predictors and sequelae of trajectories of physical aggression in school-age boys and girls. Dev Psychopathol 2010, 22:133-150. 10.1017/S0954579409990319, 20102652.
11. Gillberg C, Hellgren L. Outcome. Hyperactivity Disorders of Childhood 1996, Cambridge: Cambridge University Press, Sandberg S.
12. Spencer T, Biederman J, Wilens T, Harding M, O'Donnell D, Griffin S. Pharmacotherapy of attention-deficit hyperactivity disorder across the life cycle. J Am Acad Child Psy 1996, 35:409-432.
13. The MTA Cooperative Group The NIMH MTA follow-up: 24-month outcomes of treatment strategies for attention-deficit/hyperactivity disorder (ADHD). Pediatrics 2004, 113:754-761. The MTA Cooperative Group.
14. Klein R, Abikoff H, Hechtman L, Weiss G. Design and rationale of controlled study of long-term methylphenidate and multimodal psychosocial treatment in children with ADHD. J Am Acad Child Psy 2004, 43:792-801.
15. Connor D, Glatt S, Lopez I, Jackson D, Melloni R, . Psychopharmacology and aggression.I A meta-analysis of stimulant effects on overt/covert aggression-related behaviors in ADHD. J Am Acad Child Psy 2002, 41:253-261. Psychopharmacology and aggression.I.
16. Klein R, Abikoff H, Klass E, Ganeles D, Seese L, Pollack S. Clinical efficacy of methylphenidate in conduct disorder with and without attention deficit hyperactivity disorder. Arch Gen Psychiat 1997, 54:1073-1080.
17. Campbell M, Small A, Green W, Jennings S, Perry R, Bennett W, Anderson L. Behavioral efficacy of haloperidol and lithium carbonate: a comparison in hospitalized aggressive children with conduct disorder. Arch Gen Psychiat 1984, 41:650-656.
18. Malone R, Delaney M, Luebbert J, Cater J, Campbell M. A double-blind placebo-controlled study of lithium in hospitalized aggressive children and adolescents with conduct disorder. Arch Gen Psychiat 2000, 57:649-654. 10.1001/archpsyc.57.7.649, 10891035.
19. Campbell M, Adams P, Small A, Kafantaris V, Silva R, Shell J, Perry R, Overall J. Lithium in hospitalized aggressive children with conduct disorder: a double-blind and placebo-controlled study. J Am Acad Child Adolesc Psychiatry 34:445-453.
20. Rifkin A, Karajgi B, Dicker R, Perl E, Boppana V, Hasan N, Pollack S. Lithium treatment of conduct disorders in adolescents. Am J Psychiat 1997, 154:554-555.
21. Donovan S, Stewart J, Nunes E, Quitkin F, Parides M, Daniel W, Susser E, Klein D. Divalproex treatment for youth with explosive temper and mood lability: a double-blind, placebo-controlled crossover design. Am J Psychiat 2000, 157:818-820. 10.1176/appi.ajp.157.5.818, 10784478.
22. Steiner H, Petersen M, Saxena K, Ford S, Matthews Z. Divalproex sodium for the treatment of severe conduct disorder: A randomized controlled clinical trial. J Clin Psychiat 2003, 64:1183-1191.
23. Kafantaris V, Campbell M, Padron-Gayol M, Small A, Locascio J, Rosenberg C. Carbamazepine in hospitalized aggressive conduct disorder children: an open pilot study. Psychopharmacol Bull 1992, 28:193-199.
24. Cueva J, Overall J, Small A, Armenteros J, Perry R, Campbell M. Carbamazepine in aggressive children with conduct disorder: a double-blind and placebo-controlled study. J Am Acad Child Psy 1996, 35:480-490.
25. Connor D, Fletcher K, Swanson J. A meta-analysis of clonidine for symptoms of attention-deficit hyperactivity disorder. J Am Acad Child Psy 1999, 38:1551-1559.
26. Sallee F, Lyne A, Stat C, Wigal T, McGough J. Long-term safety and efficacy of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder. J Child Adol Psychop 2009, 19:215-226.
27. Connor D, Barkley R, Davis H. A pilot study of methylphenidate, clonidine, or the combination in ADHD comorbid with aggressive oppositional defiant or conduct disorder. Clin Pediatr 2000, 39:15-25.
28. Hazell P, Stuart J. A randomized controlled trial of clonidine added to psychostimulant medication for hyperactive and aggressive children. J Am Acad Child Psy 2003, 42:886-894.
29. . FDA Center for Drug Evaluation and Research, Drug Details Guanfacine hydrochloride. FDA Center for Drug Evaluation and Research, Drug Details., http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=GUANFACINE%20HYDROCHLORIDE
30. . FDA Center for Drug Evaluation and Research, Drug Details Clonidine hydrochloride. FDA Center for Drug Evaluation and Research, Drug Details., http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=CLONIDINE%20HYDROCHLORIDE
31. Cheng-Shannon J, McGough J, Pataki C, McCracken J. Second-generation antipsychotic medications in children and adolescents. J Child and Adol Psychop 2004, 14:372-394.
32. Findling R, McNamara N, Branicky L, Schluchter M, Lemon E, Blumer J. A double-blind pilot study of risperidone in the treatment of conduct disorder. J Am Acad Child Psy 2000, 39:509-516.
33. Aman M, DeSmedt G, Derivan A, Lyons B, Findling R, . Risperidone Disruptive Behavior Study Group Double-blind, placebo-controlled study of risperidone for the treatment of disruptive behaviors in children with subaverage intelligence. Am J Psychiat 2002, 159:1337-1346. 10.1176/appi.ajp.159.8.1337, 12153826, Risperidone Disruptive Behavior Study Group.
34. Snyder R, Turgay A, Aman M, Binder C, Fishman S, Carroll A, . the Risperidone Conduct Study Group Effects of risperidone on conduct and disruptive behavior disorders in children with subaverage IQs. J Am Acad Child Psy 2002, 41:1026-1036. the Risperidone Conduct Study Group.
35. Findling R, Aman M, Eerdekens M, Derivan A, Lyons B, . the Risperidone Disruptive Behavior Study Group Long-term, open-label study of risperidone in children with severe disruptive behaviors and below-average IQ. Am J Psychiat 2004, 161:677-684. 10.1176/appi.ajp.161.4.677, 15056514, the Risperidone Disruptive Behavior Study Group.
36. Turgay A, Binder C, Snyder R, Fisman S. Long-term safety and efficacy of risperidone for the treatment of disruptive behavior disorders in children with subaverage IQs. Pediatrics 2002, 110:e34. 10.1542/peds.110.3.e34, 12205284.
37. Dunbar F, Kusumakar V, Daneman D, Schulz M. Growth and sexual maturation during long-term treatment with risperidone. Am J Psychiat 2004, 161:918-920. 10.1176/appi.ajp.161.5.918, 15121661.
38. Rapport MD, Denney C, DuPaul GJ, Gardner MJ. Attention deficit disorder and methylphenidate: normalization rates, clinical effectiveness, and response prediction in 76 children. J Am Acad Child Psy 1994, 33:882-893.
39. Blader JC, Pliszka SR, Jensen PS, Schooler NR, Kafantaris V. Stimulant-Responsive and Stimulant-Refractory Aggressive Behavior among Children With ADHD. Pediatrics 2010, 126:e796-e806. 10.1542/peds.2010-0086, 2956067, 20837589.
40. Duffy FF, Narrow WE, Rae DS, West JC, Zarin DA, Rubio-Stipec M, Pincus HA, Regier DA. Concomitant pharmacotherapy among youths treated in routine psychiatric practice. J Child Adol Psychop 2005, 15:12-25.
41. Comer JS, Olfson M, Mojtabai R. National Trends in Child and Adolescent Psychotropic Polypharmacy in Office-Based Practice, 1996-2007. J Am Acad Child Psy 2010, 49:1001-1010.
42. American Academy of Child and Adolescent Psychiatry Practice Parameter on the Use of Psychotropic Medication in Children and Adolescents. J Am Acad Child Adolesc Psychiatry 2009, 48:961-973. American Academy of Child and Adolescent Psychiatry.
43. American Academy of Child and Adolescent Psychiatry Practice parameter for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry 2007, 46:894-921. American Academy of Child and Adolescent Psychiatry.
44. Palumbo DR, Sallee FR, Pelham WE, Bukstein OG, Daviss WB, McDermott MP, . the CAT Study Team Clonidine for attention-deficit/hyperactivity disorder: I. Efficacy and tolerability outcomes. J Am Acad Child Adolesc Psychiatry 2008, 47:180-188. 10.1097/chi.0b013e31815d9af7, 18182963, the CAT Study Team.
45. Tourette's Syndrome Study Group Treatment of ADHD in children with tics: a randomized controlled trial. Neurology 2002, 58:527-536. Tourette's Syndrome Study Group.
46. Kollins S, Findling RA, Wigal SB, Brams M, Segal SD, Khayrallah M. Modified-release clonidine for the treatment of children/adolescents with ADHD. Poster presented at 56th Annual Meeting of the American Academy of Child and Adolescent Psychiatry, Honolulu, HI 2009,
47. Blader JC, Schooler NR, Jensen PS, Pliszka SR, Kafantaris V. Adjunctive divalproex versus placebo for children with ADHD and aggression refractory to stimulant monotherapy. Am J Psychiatry 2009, 166:1392-1401. 10.1176/appi.ajp.2009.09020233, 2940237, 19884222.
48. Kronenberger WG, Giauque AL, Lafata DE, Bohnstedt BN, Maxey LE, Dunn DW. Quetiapine addition in methylphenidate treatment-resistant adolescents with comorbid attention-deficit/hyperactivity disorder, conduct/oppositional-defiant disorder, and aggression: A prospective, open-label study. J Child Adolesc Psychopharm 2007, 17:334-347.
49. Penzner JB, Dudas M, Saito E, Olshanskiy V, Parikh U, Kapoor S, Checkuri R, Gadaleta D, Avedon J, Sheridan E, Randell J, Malhotra A, Kane J, Correll C. Lack of effect of stimulant combination with second-generation antipsychotics on weight gain, metabolic changes, prolactin levels, and sedation in youth with clinically relevant aggression or oppositionality. J Child Adol Psychop 2009, 19:563-573.
50. Weiss M, Panagiotopoulos C, Giles L, Gibbins C, Kuzelijevic B, Davidson J, Harrison R. A Naturalistic Study of Predictors and Risks of Atypical Antipsychotic Use in an Attention-Deficit/Hyperactivity Disorder Clinic. J Child Adol Psychop 2009, 19:575-582.
51. Bienvenu O, Davydow D, Kendler K. Psychiatric 'diseases' versus behavioral disorders and degree of genetic influence. Psychol Med 2011, 41:33-40. 10.1017/S003329171000084X, 20459884.
52. Cunningham C, Bremner R, Secord M. COPE The Community Parent Education Program: Leader's Manual. 1998, Hamilton, Ontario, Canada: COPE Works!.
53. Greenhill LL, Swanson JM, Vitiello B, Davies M, Clevenger W, Wu M, Severe JB, Arnold LE, Abikoff HB, Conners CK, Elliott G, Hechtman L, Hinshaw SP, Hoza B, Jensen PS, Kraemer HC, March JS, Newcorn JH, Pelham WE, Wells K, Wigal T. Impairment and deportment responses to different methylphenidate doses in children with ADHD: the MTA titration. J Am Acad Child Psy 2001, 40:180-187.
54. Aman MG, Leone S, Lecavalier L, Park L, Buican B, Coury D. The Nisonger Child Behavior Rating Form--Typical IQ Version, for children with typical IQ. Int Clin Psychopharm 2008, 23:232-242.
55. Guy W. ECDEU Assessment Manuel for Psychopharmacology, Revised. US Department Health Education and Welfare Pub (ADM) 1976, 76-338. Rockville, MD: National Institute of Mental Health.
56. Johnson CR, Butter EM, Handen BL, Sukhodolsky DG, Mulick JA, Lecavalier L, Aman MG, Arnold LE, Scahill L, Stigler KA, McDougle CJ. Standardized observation analogue procedure (SOAP) for assessing parent and child behaviors in clinical trials. J Intellect Dev Disabil 2009, 34:230-238. 10.1080/13668250903074471, 2739602, 19681003.
57. Stanford M, Houston R, Mathias C, Greve K, Villemarette-Pittman N, Adams D. A double-blind placebo controlled crossover study of phenytoin in individuals with impulsive aggression. Psychiatry Res 2001, 103:193-203. 10.1016/S0165-1781(01)00287-6, 11549407.
58. Brown K, Atkins MS, Osborne ML, Milnamow M. A revised teacher rating scale for reactive and proactive aggression. J Abnorm Child Psych 1996, 24:473-480.
59. Kabacoff RI, Miller IW, Bishop DS, Epstein NB, Kestner GI. A psychometric study of the MacMaster Family Family Device in psychiatric, medical, and nonclinical samples. J Fam Psychol 1990, 3:431-439.
60. Coccaro EF, Harvey PH, Kupshaw-Lawrence E, Herbert JL, Bernstein DP. Development of neuropharmacologically based behavioral assessments of impulsive aggressive behavior. J Neuropsych Clin N 1991, 3:44-51.
61. Kaufman J, Birmaher B, Brent D, Rao U, Flynn C, Moreci P, Williamson D, Ryan N. Schedule for affective Disorders and schizophrenia for School Age Children: Present and Lifetime version (KSADS--PL): Initial reliability and validity data. J Am Acad Child Psy 1997, 36:980-988.
62. Puig-Antich J, Chambers W. The Schedule for Affective Disorders and Schizophrenia for school-aged children. Unpublished interview schedule. 1978, New York, NY: New York State Psychiatric Institute.
63. Youngstrom EA, Findling RL, Danielson CK, Calabrese JR. Discriminant validity of parent report of hypomanic and depressive symptoms. Psychol Assessment 2001, 13:267-276.
64. Gadow KD, Sprafkin J. Child and Adolescent Symptom Inventory-4R. 2005, Stony Brook, NY: Checkmate Plus.
65. Gadow KD, Sprafkin J. ADHD Symptom Checklist -4 2008 Manual. 2008, Stony Brook, NY: Checkmate Plus.
66. Simpson GM, Angus JW. A rating scale for extrapyramidal side effects. Acta Psychiat Scand 1970, 212:11-19.
67. Barnes T. A rating scale for drug-induced akathisia. Brit J Psychiat 1989, 154:672-676. 10.1192/bjp.154.5.672, 2574607.
68. Aman M, Binder C, Turgay A. Risperidone Effects in the Presence/Absence of Psychostimulant Medicine in Children with ADHD, Other Disruptive Behavior Disorders, and Subaverage IQ. J Child Adol Psychopharm 2004, 14:243-254.