Table 1.

Key Characteristics of the Six Multisite RCT

Study	Aim	N	Age Range	IQ evaluation	Treatment Target	Outcome Measures	Entry Criteria	Primary finding
Aman et al., 2009¹⁸	RIS alone vs. RIS + PT	124	4-14	ASB Leiter MSEL	Irritability	ABC–I HSQ CGI-I	ABC-I ≥ 18 CGI-S ≥ 4	RIS + PT > RIS
Bearss et al., 2015¹⁹	PT vs PEP	180	3-6	MSEL	Irritability	ABC-I HSQ-ASD CGI-I	ABC-I ≥ 15 CGI-S ≥ 4	PT > PEP
Handen et al., 2015²⁰	ATX vs placebo and PT vs no PT	128	5-14	ASB MSEL	Hyperactivity and Inattention	CGI-I SNAP HSQ ABC	SNAP-IV M ≥ 1.5 CGI-S ≥ 4	ATX & PT > placebo
RUPP Autism Network, 2002²¹	RIS vs. Placebo	101	5-17	NR	Irritability	ABC-I CGI-I	ABC-I ≥ 18 CGI-S ≥ 4	RIS > Placebo
RUPP Autism Network, 2005²²	MPH vs. Placebo	72	5-17	SIT	Hyperactivity	ABC-H CGI-I	SNAP-IV ADHD ≥ 27 SNAP-IV H-I ≥ 10 CGI-S ≥ 4	MPH > Placebo
Scahill et al., 2015²³	GUAN vs Placebo	62	5-14	ASB MSEL	Hyperactivity	ABC-H ADHD Rating Scale CGI-I	ABC-H ≥ 24 CGI-S ≥ 4	GUAN > Placebo

Abbreviations: GUAN=Guanfacine; MPH=Methylphenidate; RIS=Risperidone; PEP=Parent education; PT=Parent Training; ASB= Abbreviated Stanford-Binet Intelligence Scales, fifth edition (Roid, 2003); Leiter= Leiter International Performance Scale (Roid and Miller, 1997); MSEL= Mullen Scale of Early Learning (Mullen, 1995); NR=Not reported; SIT= Slosson Intelligence Test (Slosson, 1983); ABC-I= Aberrant Behavior Checklist-Irritability subscale; HSQ=Home Situation Questionnaire; CGI-I=Clinical Global Impression-Improvement; HSQ-ASD= Home situation Questionnaire-Autism Spectrum Disorder; CYBOCS-PDD= Children’s Yale-Brown Obsessive-Compulsive Scale-Modified for Pervasive Developmental Disorders; RBS-R=Repetitive Behavior Scale-Revised; ABC-H= Aberrant Behavior Checklist-hyperactivity subscale; SNAP-IV ADHD= Swanson, Nolan, and Pelham– version IV ADHD subscale; SNAP-IV H/I= Swanson, Nolan, and Pelham– version IV Hyperactivity/Impulsivity subscale; M = mean