treating disruptive behavior in children with asd january...
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Treating Disruptive Behavior in Children
with ASD
January 22, 2017
Lawrence Scahill, MSN, PhD Professor of Pediatrics
Marcus Autism Center
Emory University
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Disclosures
Consultant
• Roche
• Neuren
• Supernus
Rater Training • Bracket
Royalties
• Oxford, Guilford
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Completed NIH-funded Multisite Trials in ASD past 20 yrs Study N Target Ages Results Published
Risperidone vs placebo
101 Irritability (tantrums, Aggression & SIB)
5-17 A > P +++
NEJM, 2002
Methylphenidate vs placebo
66 Hyperactivity 5-14 A> P +
Arch Gen Psych, 2005
Citalopram vs placebo
149 Repetitive Behavior 5-17 A=P Arch Gen Psych, 2009
RIS vs RIS + Parent Training
124 Irritability & Adaptive Behavior
4-13 COMB > RIS
J Am Acad Child Psych, 2009, 2012, 2016
Guanfacine vs placebo
62 Hyperactivity 5-14 A > P ++
Am J Psych, 2015
Parent Training vs Parent Education
180 Irritability & Adaptive Behavior
3-7 PT > PE ++
JAMA, 2015; J Am Acad Child Psych, 2016
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Characteristics of Participants RUPP Trials By Sex (N=533; Age 7.0 ± 2.5)
Characteristic Male Female
N (%) 457 (85.7%) 76 (14.3%)
IQ < 70 190 (43.3%) 35 (49.3%)
IQ ≥ 70 249 (56.7%) 36 (50.7%)
Mean (SD) Mean (SD)
Vineland Communication 65.9 ±22.3 61.8 ± 24.6
Vineland Socialization 62.5 ± 16.2 59.5 ± 16.4
Vineland Daily Living 59.8 ± 23.5 57.3 ± 26.1
Aberrant Behavior Checklist
Irritability 24.1 ± 8.5 24.1 ± 9.2
Social Withdrawal 14.1 ± 8.8 14.1 ± 8.7
Stereotypy 8.0 ± 5.3 7.9 ± 5.6
Hyperactivity 33.1 ± 8.8 30.5 ± 8.8
Inappropriate Speech 5.9 ± 3.5 5.9 ± 3.8
CYBOCS Total 13.9 ± 3.9 13.8 ±3.9
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RUPP Autism Network: Irritability Scale
RUPP Autism Network, 2002. NEJM, 347(5): 314-321.
0
5
10
15
20
25
30
0 2 4 6 8
Week
AB
C I
rrit
ab
ilit
y T
ota
l
Risperidone mean
Placebo mean
Mean =1.8 mg/day; ES=1.3
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Clinical Global Impression-Improvement
1 = Very Much Improved
2 = Much Improved
3 = Minimally Improved
4 = No Change
5 = Minimally Worse
6 = Much Worse
7 = Very Much Worse
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CGI-Improvement: RIS vs Placebo
Group Positive
Response
Negative
Response
RIS 40 (75.5%) 9 (24.5%)
Placebo 6 (11.5%) 46 (88.5%)
p< 0.001
RUPP Autism Network. NEJM, 347(5): 314-321.
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Risperidone only vs Risperidone + Parent
Training (Aman et al., 2009; Scahill et al., 2012)
Design
• 6-month randomized trial
•124 subjects (age 4 to 13 years)
• Random assignment
– risperidone only (N=49) or
– risperidone + Parent training (N=75)
J Am Acad Child Adolesc Psych, 2009, 2012
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ABC Irritability
10
12
14
16
18
20
22
24
26
28
30
BL Week 8 Week 16 Week 24
HS
Q S
co
re
MED
COMB
ES = .48
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Weight Gain and Metabolic Consequences of Risperidone in Young Children With Autism
Spectrum Disorder
Scahill L, Jeon S, Boorin SJ, McDougle CJ, Aman MG, Dziura J, McCracken JT, Caprio S, Arnold LE, Nicol G, Deng Y, Challa SA, Vitiello B (2016)
JAmAcademy Child & Adolescent Psychiatry
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0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
BL Wk 8 Wk 16 Wk 24
Normal Wt
Over Wt
Obese
Column1
% s
ub
ject
s b
y W
t g
rou
p
Change in Weight Category over 24 Weeks (N=97)
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RUPP #2: Risperidone and Risperidone + Parent Training (N=97)
Weight, Waist Circumference: Baseline & Week 24
Baseline
Mean (SD)
Week 24
Mean (SD)
Measure Baseline Week 24 Mean Change (SD)*
Weight in kg 29.3 (11.5) 34.0 (12.6) 5.3 (3.4)
Waist circum. in cm 60.7 (10.4) 66.8 (11.3) 6.1 (5.18)
* Statistically significant
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Growth curves for children with ASD exposed to risperidone (N=97) Whole sample with 95% CI and subgroup by reported appetite
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Rubinetwork.org
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RUBI: Study Objectives and Design
• Efficacy Study
– Parent Training vs Parent Education*
– Children (3-7 yrs) with ASD & DBP
• 24 Week Trial
– At Wk 24, a blinded independent evaluator (IE)
classified subject as + or - response
• Follow-up:Wk 36 & 48 (not discussed here)
*active comparator
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Participants
• 3-0 to 6-11 years
• N=180
• DSM-IV Diagnosis of ASD
• > 15 on the parent-rated Aberrant Behavior
Checklist Irritability (ABC-I) subscale
• Stable medication/treatment plan
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Program Structure
Parent Training
• Week 1-16
- 11 Core Sessions
- 2 Home Visits
- Up to 2 Optional Sessions
• toileting, feeding, sleep, time out
Parent Education
• Week 1-24
- 12 Core Sessions
- 1 Home Visit
Both treatments: 1:1 with parent, using the same format
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Primary & Key Secondary Outcome Measures
• Parent-reported outcomes
– Aberrant Behavior Checklist-Irritability subscale
– Vineland
• Blinded Independent Evaluator
– Parent Target Problems via parent interview
– Improvement item of the Clinician Global Impression
• Much/Very Much Improved = + Response
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Baseline Characteristics
• 88% boys
• mean age = 4.7 +1.1 years
• 74% IQ >70
• 87% Caucasian
• 14% Hispanic
• 69% Autistic Disorder
• 46% in Regular Education class
• 20% on stable psychotropic medication
• 88% two-parent family
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ABC-I LSM Outcomes
10
12
14
16
18
20
22
24
Baseline Week 4 Week 8 Week 12 Week 16 Week 20 Week 24
Parent Training
Parent Education
Pp < .001
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CGI Positive Response
0
10
20
30
40
50
60
70
80
Baseline Week 4 Week 8 Week 12 Week 16 Week 20 Week 24
Parent Training
Parent Education
p < .001
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Vineland Daily Living Skills: Standard Scores
73
74
75
76
77
78
79
80
81
82
83
84
Baseline Week 24
Parent Training
Parent Education
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Conclusion
• Largest RCT of a behavioral intervention for
children with ASD.
• Structured, relatively brief PT program was
superior to PEP for disruptive behavior and
daily living skills
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Future Directions
• Dissemination
– Getting the word out: not enough
• Implementation
– Reach: access in clinics & schools
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Thank You