Therapies for Children With Autism Spectrum Disorders

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Evidence Table. Therapies for children with ASD (continued) Study Inclusion/ Exclusion Baseline Description Intervention Criteria/ Population Measures Outcomes NR therapist (blinded) Mental age: G2: NR* G1/BL: P = 0.021 Author industry worked with both NR Expressive syntax: G2/BL: P = 0.001 relationship groups Gender, n: G1: NR* G1/G2: P = 0.034 disclosures: • Scalp acupuncture G1, n: G2: NR* Expressive NR performed by physician Male: Phonology: semantics: Design: (specialized pediatric G1: 5 G1: NR* G1: 4.4 ± 3.4 RCT acupuncturist) G2: 7 G2: NR* G2: 4.1 ± 3.4 Assessments: Female: Pragmatics: G1/BL: P = 0.031 Battery of examinations G1: 5 G1: NR* G2/BL: P = 0.021 before and after G2: 3 G2: NR* G1/G2: P = 0.545 treatment, including Race/ethnicity: Receptive syntax: communicative assess- NR G1: NR* ment and an Arab SES: G2: NR* language test Maternal education: NR G1/BL: P = NS Co-interventions held Household income: NR G2/BL: P = NS stable during treatment: Diagnostic approach: G1/G2: P = NS None In Study Expressive Frequency of contact Diagnostic tool/ syntax: during study: method: G1: NR* Assessments conducted DSM-IV-T, parent-rated G2: NR* once prior to initiation of ADI-R G1/BL: P = NS therapy and once post- Diagnostic category, n G2/BL: P = NS therapy; twice a week (%): G1/G2: P = NS during therapy Autism: 20 (100) Phonology: Concomitant therapies: Other characteristics, n G1: NR* NR (%): G2: NR* N at enrollment: Delayed language G1/BL: P = NS G1: 10 development: 20 (100) G2/BL: P = NS G2: 10 G1/G2: P = NS N at follow-up: Pragmatics: G1: 10 G1: NR* G2: 10 G2: NR* G1/BL: P = NS G2/BL: P = NS G1/G2: P = NS Harms: NR Allam et al., 2008 Modifiers: (continued) Comments: *Data for nonsignificant results was not reported. NR Author: Aman et al., 2005 McDougle et al., 2005^ Arnold et al., 2003† RUPP, 2002‡ Williams et al, 2006º Anderson et al., 2007ª Aman et al., 2008§ Martin et al., 2004¥ Country: US RCT intervention (8 weeks): Risperidone or placebo Dosage by weight: • 20-45 kg: Initial dose of 0.5 mg at bedtime; increased to 0.5 mg twice daily on day 4; gradually increased in 0.5 mg increments to a maximum of 2.5 mg/ day (1.0 mg AM, 1.5 mg bedtime) by day 29 • > 45 kg: slightly acelerated dose schedule, with maximal dose of Inclusion criteria: • Children meeting DSM-IV criteria for autistic disorder, with tantrums, aggression, self-injurious behavior, or a combination of these problems • Aged 5 to 17 years • Weight ≥ 15 kg • Mental age ≥ 18 months • Clinically significant behavioral problems with clinician-determined rating of ≥ moderate on CGI-S and score ≥ 18 on C-116 Overall ratings: RLRS score, mean ± SD:^ Overall: G1: 0.94 ± 0.36 G2: 1.03 ± 0.37 Affectual reactions: G1: 1.68 ± 0.64 G2: 1.84 ± 0.64 Social skills: RLRS social relationship to people score, mean ± SD:^ G1: 0.60 ± 0.43 G2: 0.72 ± 0.43 Overall ratings: Rate of positive response (≥ 25% improvement on ABC irritability subscale and rating of much improved or very much improved on CGI-I scale), post- RCT, n (%):‡ G1: 34 (69)** G2: 6 (12) G1/G2: P < 0.001 Rate of positive response, 8 week
Evidence Table. Therapies for children with ASD (continued) Study Inclusion/ Exclusion Baseline Description Intervention Criteria/ Population Measures Outcomes Practice 1.5 mg AM and 2.0 mg ABC Irritability subscale VABS socialization open label trial, n setting: bedtime rated by parent and score, mean ± SD:‡ (%):^ Academic centers • < 20 kg: initial dose 0.25 confirmed by caregiver G1: 49.1 ± 16.6 G1: 29/46 (63) Intervention mg/day (children reassessed at G2: 47.4 ± 10.1 RLRS overall setting: Scheduled dose increase baseline, 7-14 days after Communication/ score, mean ± Clinic could be delayed due to initial assessment to language: SD:^ Enrollment AEs or marked improve- confirm first values) RLRS language Post-RCT: period: ment at lower dose; dose Exclusion criteria: score, mean ± SD:^ G1: 0.45 ± 0.31 June 1999 to April reductions to manage side • Serious medical G1: 0.28 ± 0.38 G2: 0.88 ± 0.40 2001 effects allowed at any disorders G2: 0.46 ± 0.42 G1/G2: P < 0.001 Funding: time; no dose increases • Other psychiatric VABS communica- (ES = 1.08) NIH; Kor-czak after day 29 disorders requiring tion score, mean ± Post-extension Foundation; Daily dose during final medication SD:‡ Janssen (provided study week, mean mg • Children receiving a G1: 45.0 ± 16.7 study medication) (range): psychotropic drug that G2: 42.0 ± 14.3 Author industry G1: 1.8 ± 0.7 (0.5-3.5) was deemed effective for Repetitive relationship G2: 2.4 ± 0.6 (1.0-3.5) the treatment of behavior: disclosures: Open label extension aggression, tantrums, or ABC stereotypy NR^‡ª¥ trial (8 weeks): self-injurious behavior score, mean ± SD:‡ 1 of 15† The 46 RCT placebo non- Age, RCT population, G1: 10.6 ± 4.9 Lilly (1) responders underwent an years (range): G2: 9.0 ± 4.4 McNeil (1) open label trial of 8.8 ± 2.7 (5-17) Problem behavior: Novartis (1) risperidone after the RCT, Prepubertal, RCT ABC score, mean ± Noven (1) with the same dosage population, n (%): 88 (87) SD:‡ Shire (1) schedule as the RCT Mental age: Irritability: Sigma Tau (1) Mental development, RCT G1: 26.2 ± 7.9 8 of 17º Assessments: population, n (%): G2: 25.5 ± 6.6 Abbott (2) Lab tests, ECGS, prolactin Average or above average Social withdrawal: AGS Publishing (2 and VABS maladaptive IQ: G1: 16.4 ± 8.2 VABS royalties) behavior pre- and post- G1: 3/46 (7) G2: 16.1 ± 8.7 AstraZenca (1) RCT and post-extension G2: 2/45 (4) Hyperactivity: Borderline IQ: G1: 31.8 ± 9.6 Vital signs, height, weight, G1: 8/46 (17) G2: 32.3 ± 8.5 side effects, sleep log, G2: 4/45 (9) SARS, AIMS at each visit Mild or moderate retardation: G1: 20/46 (43) G2: 23/45 (51) phase: G1: 0.39 ± 0.35 RLRS affectual reactions score, mean ± SD:^ Post-RCT: G1: 0.88 ± 0.56 G2: 1.60 ± 0.71 G1/G2: P < 0.001 (ES = 1.10) Post-extension phase: G1: 0.78 ± 0.58 Social skills: RLRS social relationship to people score, mean ± SD:^ Post-RCT: G1: 0.15 ± 0.42 G2: 0.46 ± 0.52 G1/G2: P = NS (ES = 0.68) Aman et al., 2005 RLRS at pre-, mid- and Severe retardation: Inappropriate Post-extension McDougle et al., post-RCT, monthly G1: 15/46 (33) speech: phase: 2005^ thereafter G2: 16/45 (36) G1: 4.8 ± 4.1 G1: 0.00 ± 0.42 Arnold et al., CYBOCS, CGI and ABC Gender, RCT population, G2: 6.5 ± 3.6 VABS socializa- 2003† bi-weekly during RCT and n (%): VABS maladaptive tion, standard RUPP, 2002‡ monthly thereafter Male: behavior score, score, post- Williams et al, Target symptoms, G1: 39 (80) mean ± SD:^ extension phase, 2006º California VLT, Dot Test, G2: 43 (52) Part 1: mean change ± Anderson et al., Cancellation and Purdue Female: G1: 24.89 ± 6.91 SD:º 2007ª Peg Board tasks pre-, mid- G1: 10 (20) G2: 25.22 ± 5.72 G1: 1.83 ± 9.64 Aman et al., 2008§ and post-RCT G2: 9 (17) Part 2: (n=48) Martin et al., VABS at pre-RCT and Race/ethnicity, RCT G1: 8.37 ± 2.59 G1/BL: P = NS 2004¥ post-extension population, n (%): G2: 8.29 ± 3.66 (ES = 0.14) (continued) Groups: White: 67 (66) Total: Communication/ Bristol-Myers G1: risperidone Black: 11 (11) G1: 33.26 ± 8.38 language: Squibb (3) G2: placebo Hispanic: 7 (7) G2: 33.51 ± 8.29 RLRS language Cephalon (1) Asian: 8 (8) Adaptive behavior: score, mean ± Forest (1) Co-interventions held Other: 8 (8) VABS score, mean ± SD:^ Jannssen (5) stable during treatment: SES: SD:‡ Post-RCT: C-117
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Comparative Effectiveness Review Nu
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This report is based on research co
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Acknowledgments We are indebted to
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Therapies for Children With Autism
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Dietary and Other Medical Intervent
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Figures Figure A. Analytic framewor
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Table A. Description of interventio
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Analytic Framework Figure A. Analyt
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Strength of evidence. The degree of
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epetitive behavior showed improveme
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subgroups of children, although the
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We encourage investigators to provi
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9. Remington B, Hastings RP, Kovsho
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46. Green J, Charman T, McConachie
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82. Reaven JA, Blakeley-Smith A, Ni
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120. Masi G, Cosenza A, Mucci M, et
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157. Evangeliou A, Vlachonikolis I,
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Introduction Need for Evidence for
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Interventions intended primarily to
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Table 1. Description of behavioral
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Serotonin reuptake inhibitors. Sero
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Table 3. Description of medical and
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Table 4. Description of allied heal
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Key Questions and Analytic Framewor
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Chapter 4 discusses the results in
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Methods This chapter documents proc
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• Did not present aggregated resu
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Additional behavioral interventions
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1. Did the study employ a group des
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Scoring: Studies minimally had to h
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These ratings of applicability do n
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Figure 2. Disposition of articles a
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• ABA-based approaches including
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education, children in the intensiv
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abilities. This finding is further
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Table 10. Outcomes of early intensi
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forecast behavior; perspective taki
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interaction with peers; outcome mea
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hyperactivity, inattention, challen
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Table 12. Outcomes of RCTs assessin
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Schedule for Affective Disorders an
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SCAS-P=Spence Child Anxiety Scale-P
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Summary of the literature. Jarusiew
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Table 14. Overview of educational s
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on the Ankara Developmental Screeni
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Checklist scores decreased by 8.4 f
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Table 15. Outcomes of studies asses
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evaluated the effects of risperidon
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that this somnolence improved over
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Table 17. Outcomes of RCTs of antip
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Serotonin Reuptake Inhibitors SRIs
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One prospective case series of esci
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Most participants were recruited fr
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Dietary and Other Medical Intervent
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Summary of the literature-other int
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withdrew after the first six weeks;
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therefore described separately belo
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addressed, 85 typically involves on
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In the second paper, 89 treatment s
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Table 25. Overview of CAM studies a
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Teacher and Parent Scales, behavior
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Because of the potentially increase
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Educational Interventions Child cha
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showed diminished response to escit
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oom as the other assessments, so it
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contrast group (n=18) on three meas
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and are based on consideration of f
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Few studies directly comparing the
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Strength of evidence. The strength
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While individual studies of CBT and
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Table 32. Summary of results of edu
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Table 33. Summary of results of med
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strength of this reviewed literatur
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Table 36. Intervention, strength of
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Table 37. Interventions/outcomes wi
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gains. 104 Other studies have seen
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percent of behavioral studies repor
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limited followup, lack of comparati
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individual intervention is warrante
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selecting participants for their st
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studies lacked an arm that consider
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23. Kanner L. Autistic Disturbances
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62. Dosman CF, Drmic IE, Brian JA,
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104. Ben-Itzchak E and Zachor DA. T
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142. Tyminski RF and Moore PJ. The
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177. Aman MG, McDougle CJ, Scahill
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214. Correia CT, Almeida JP, Santos
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252. Akhondzadeh S, Tajdar H, Moham
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290. Dawson G, Rogers S, Munson J,
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Acronyms/Abbreviations ABA Applied
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Appendix A. Exact Search Strings an
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Table A2. PsycINFO search strategie
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Therapies for Children with Autism
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Therapies for Children with ASD Sys
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Appendix C. Evidence Tables Tables
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Evidence Table. Therapies for child
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Country: US Practice setting: Clini
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Dunn-Geier et al., 2000 (continued)
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Evidence Table: Therapies for Child
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Appendix D. List of Excluded Studie
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31. Aarsland D, Cummings JL and Lar
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59. Ahearn WH, Clark KM, Gardenier
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89. Allison DB, Basile VC and MacDo
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118. Ando H, Yoshimura I and Wakaba
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146. Atkinson RP, Jenson WR, Rovner
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177. Bakare MO, Agomoh AO, Ebigbo P
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204. Baron-Cohen S, Scott FJ, Allis
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233. Bebko JM, Perry A and Bryson S
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262. Bergmann F, Stepp H, Metzger R
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291. Birkan B, McClannahan LE and K
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319. Boddy F, Rowan EN, Lett D, et
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348. Bouma R and Schweitzer R. The
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376. Broadstock M, Doughty C and Eg
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404. Brudnak MA. Application of gen
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432. Buitelaar JK. Why have drug tr
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460. Butler DE, Nordin IC, L’Ital
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489. Campbell M, Locascio JJ, Choro
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517. Caronna EB, Augustyn M and Zuc
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546. Case-Smith J and Miller H. Occ
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574. Charlop MH, Burgio LD, Iwata B
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602. Cheng CW, Cho SH, Taylor M, et
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631. Cicero FR and Pfadt A. Investi
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662. Collier D and Reid G. A compar
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691. Coskun M, Karakoc S, Kircelli
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718. Cullen LA, Barlow JH and Cushw
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748. Davidovitch M, Holtzman G and
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777. DeLeon IG, Fisher WW and Marhe
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805. Devlin SD, Harber MM. Collabor
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834. Doherty K, Fitzgerald M and Ma
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863. Dudley LL, Johnson C and Barne
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893. Dybvik AC. Autism and the Incl
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924. Elder JH. In-home communicatio
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953. Erickson CA, Posey DJ, Stigler
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979. Faja S, Aylward E, Bernier R,
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1008. Ferri R, Elia M, Agarwal N, e
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1037. Fisher W, Kerbeshian J and Bu
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1066. Fragala-Pinkham M, Haley SM a
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1095. Furneaux B. Keeping the balan
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1124. Garcaa-Villamisar D, Wehman P
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1152. Ghezzi PM. Discrete Trials Te
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1180. Goin-Kochel RP, Myers BJ and
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1210. Gordon R, Handleman JS and Ha
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1239. Grimaldi BL. The central role
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1268. Guptill JT, Booker AB, Gibbs
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1296. Hamdan-Allen G. Brief report:
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1324. Hare DJ, Jones JPR and Paine
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1356. Harrison S and Berry L. Valui
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1386. Heilbrun AB, Jr., Blum N and
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1414. Hetzroni OE and Shalem U. Fro
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1473. Horner RH, Carr EG, Strain PS
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1533. Ijichi S and Ijichi N. Beyond
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1562. James SJ, Cutler P, Melnyk S,
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1591. Johnson CR, Butter EM, Handen
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1619. Joyce PR. The medical model-w
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1647. Karmali I, Greer RD, Nuzzolo-
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1673. Kelly AB, Garnett MS, Attwood
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1702. Kielinen M, Linna SL and Moil
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1731. Klin A, Lin DJ, Gorrindo P, e
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1761. Koegel RL and Frea WD. Treatm
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1790. Kolmen BK, Feldman HM, Handen
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1819. Kratochvil CJ, Findling RL, M
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1846. Lam MK and Rao N. Developing
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1874. Lattimore LP, Parsons MB and
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1903. Lee PC. Verification of a sim
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1932. Lerman DC, Vorndran C, Addiso
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1960. Licciardello CC, Harchik AE a
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1989. Liptak GS, Orlando M, Yinglin
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2015. Lorimer PA, Simpson RL, Myles
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2043. Luiselli JK, Kane A, Treml T,
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2071. MacFarlane JR and Kanaya T. W
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2099. Malone RP, Maislin G, Choudhu
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2127. Marin FZ. CAM versus nucleopl
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2157. Martineau J, Roux S, Adrien J
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2185. Matson JL and Lo Vullo SV. A
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2213. McCabe H. The Importance of P
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2240. McDougle CJ, Holmes JP, Carls
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2385. Morrison RS, Sainato DM, Benc
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2413. Munesue T, Ono Y, Mutoh K, et
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2445. Napolitano DA, Tessing JL, Mc
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2474. Niederhofer H and Pittschiele
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2501. Nwora AJ and Gee BM. A case s
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2530. Olive ML, Lang RB and Davis T
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2559. Owens JA, Rosen CL and Mindel
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2589. Pansegrouw I and Alant E. Com
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2646. Perry R, Nobler MS and Campbe
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2675. Piazza CC, Hagopian LP, Hughe
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3492. Van Der Putt R, Dineen C, Jan
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3522. Vitiello B. Recent NIMH clini
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3553. Walenski M, Mostofsky SH, Gid
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3581. Weber RC and Thorpe J. Teachi
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3610. Wheeler JJ, Baggett BA, Fox J
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3637. Williams B. Mental handicap n
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3669. Wimpory D, Chadwick P and Nas
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3698. Worth S and Reynolds S. The A
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3728. Young JM, Krantz PJ, McClanna
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3759. Zuddas A, Di Martino A, Mugli
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Appendix F. Approach to Categorizin
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APPENDIX G. Discussion of Recent Sy
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one a casein free regime. Diets wer
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outcome data as Type 6, defined as
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Yes—no disclosures to make G7 Bai
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Table G1. Characteristics of recent
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Random assignment Appropriate compa
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Study Group design Random assignmen
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APPENDIX I. Applicability Summary T
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Social skills (continued) Domain De
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Therapies for Children With Autism Spectrum Disorders

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