Treatment of Severe Childhood Aggression (The TOSCA Study)

Summary

This study will determine the safety and effectiveness of two medications for treating aggression in children with attention deficit hyperactivity disorder (ADHD).

Timeline

Start

2008-08

Primary completion

2012-11

Completion

2012-11

Outcome

Met primary endpoint

paper showed statistically significant improvement on the Nisonger Child Behavior Rating Form Disruptive-Total subscale (treatment-by-time interaction, p = .0016) PMID 24342385 ↗

Publications

• Results Aman MG, Bukstein OG, Gadow KD, Arnold LE, Molina BS, McNamara NK, Rundberg-Rivera EV, Li X, Kipp H, Schneider J, Butter EM, Baker J, Sprafkin J, Rice RR Jr, Bangalore SS, Farmer CA, Austin AB, Buchan-Page KA, Brown NV, Hurt EA, Grondhuis SN, Findling RL. What does risperidone add to parent training and stimulant for severe aggression in child attention-deficit/hyperactivity disorder? J Am Acad Child Adolesc Psychiatry. 2014 Jan;53(1):47-60.e1. doi: 10.1016/j.jaac.2013.09.022. Epub 2013 Nov 18.
• Results Kaat A, Farmer C, Gadow K, Findling RL, Bukstein O, Arnold LE, Bangalore S, McNamara N, Aman M. Factor Validity of a Proactive and Reactive Aggression Rating Scale. J Child Fam Stud. 2015 Sep 1;24(9):2734-2744. doi: 10.1007/s10826-014-0075-5. Epub 2014 Nov 27.
• Results Farmer CA, Brown NV, Gadow KD, Arnold LE, Kolko DG, Findling RL, Molina BS, Buchan-Page KA, Rice RR Jr, Bangalore SS, Bukstein O, Rundberg-Rivera EV, McNamara N, Aman MG. Comorbid symptomatology moderates response to risperidone, stimulant, and parent training in children with severe aggression, disruptive behavior disorder, and attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2015 Apr;25(3):213-24. doi: 10.1089/cap.2014.0109.
• Results Rundberg-Rivera EV, Townsend LD, Schneider J, Farmer CA, Molina BB, Findling RL, Gadow KD, Bukstein OG, Arnold LE, Kolko DJ, Buchan-Page KA, McNamara NK, Michel C, Austin A, Kipp H, Rice RR, Aman MG. Participant satisfaction in a study of stimulant, parent training, and risperidone in children with severe physical aggression. J Child Adolesc Psychopharmacol. 2015 Apr;25(3):225-33. doi: 10.1089/cap.2014.0097.
• Results Arnold LE, Gadow KD, Farmer CA, Findling RL, Bukstein O, Molina BS, Brown NV, Li X, Rundberg-Rivera EV, Bangalore S, Buchan-Page K, Hurt EA, Rice R, McNamara NK, Aman MG. Comorbid anxiety and social avoidance in treatment of severe childhood aggression: response to adding risperidone to stimulant and parent training; mediation of disruptive symptom response. J Child Adolesc Psychopharmacol. 2015 Apr;25(3):203-12. doi: 10.1089/cap.2014.0104.
• Results Gadow KD, Arnold LE, Molina BS, Findling RL, Bukstein OG, Brown NV, McNamara NK, Rundberg-Rivera EV, Li X, Kipp HL, Schneider J, Farmer CA, Baker JL, Sprafkin J, Rice RR Jr, Bangalore SS, Butter EM, Buchan-Page KA, Hurt EA, Austin AB, Grondhuis SN, Aman MG. Risperidone added to parent training and stimulant medication: effects on attention-deficit/hyperactivity disorder, oppositional defiant disorder, conduct disorder, and peer aggression. J Am Acad Child Adolesc Psychiatry. 2014 Sep;53(9):948-959.e1. doi: 10.1016/j.jaac.2014.05.008. Epub 2014 Jun 12.
• Grondhuis SN, Farmer CA, Arnold LE, Gadow KD, Findling RL, Molina BSG, Kolko DJ, Buchan-Page KA, Rice RR , Jr, Butter EM, Aman MG. Standardized Observation Analogue Procedure in the Treatment of Severe Childhood Aggression Study. J Child Adolesc Psychopharmacol. 2020 Feb;30(1):48-54. doi: 10.1089/cap.2019.0109. Epub 2019 Nov 15.
• Barterian JA, Arnold LE, Brown NV, Farmer CA, Williams C, Findling RL, Kolko DJ, Bukstein OG, Molina BSG, Townsend L, Aman MG. Clinical Implications From the Treatment of Severe Childhood Aggression (TOSCA) Study: A Re-Analysis and Integration of Findings. J Am Acad Child Adolesc Psychiatry. 2017 Dec;56(12):1026-1033. doi: 10.1016/j.jaac.2017.09.426. Epub 2017 Oct 6.
• Farmer CA, Epstein JN, Findling RL, Gadow KD, Arnold LE, Kipp H, Kolko DJ, Butter E, Schneider J, Bukstein OG, McNamara NK, Molina BS, Aman MG. Risperidone Added to Psychostimulant in Children with Severe Aggression and Attention-Deficit/Hyperactivity Disorder: Lack of Effect on Attention and Short-Term Memory. J Child Adolesc Psychopharmacol. 2017 Mar;27(2):117-124. doi: 10.1089/cap.2016.0040. Epub 2016 Jun 27.
• Gadow KD, Brown NV, Arnold LE, Buchan-Page KA, Bukstein OG, Butter E, Farmer CA, Findling RL, Kolko DJ, Molina BS, Rice RR Jr, Schneider J, Aman MG. Severely Aggressive Children Receiving Stimulant Medication Versus Stimulant and Risperidone: 12-Month Follow-Up of the TOSCA Trial. J Am Acad Child Adolesc Psychiatry. 2016 Jun;55(6):469-78. doi: 10.1016/j.jaac.2016.03.014. Epub 2016 Apr 13.
• Farmer CA, Arnold LE, Bukstein OG, Findling RL, Gadow KD, Li X, Butter EM, Aman MG. The treatment of severe child aggression (TOSCA) study: Design challenges. Child Adolesc Psychiatry Ment Health. 2011 Nov 10;5(1):36. doi: 10.1186/1753-2000-5-36.

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