Therapies for Children With Autism Spectrum Disorders

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Evidence Table. Therapies for children with ASD (continued) Study Description Intervention Author: Owen et al., 2009 Country: US Practice setting: Pharmaceutical company Intervention setting: Multi-site clinics Enrollment period: June 2006 to February 2008 Funding: Bristol Myers Sqibb, Otsuka Pharmaceutical Co. Author industry relationship disclosures: 8 of 8 Abbott (1) Addrenex (1) Astra Zeneca (1) Bristol Myers Squibb (6) Curemark (1) Forest (1) GlaxoSmithKline (1) Janssen (1) Johnson & Johnson (1) KemPharm (1) Lilly (2) Lundbeck (1) Neuropharm (2) Novartis (1) Organon (1) Otsuka (4) Pfizer (2) Sanofi-Aventis (1) Seaside Pharma (1) Sepracore (1) Shire (1) Solvay (1) Intervention: An 8 week treatment phase with Aripiprazole, 2 mg/day with target dosage of 5,10, or 15 mg/day (maximum 15 mg/day) Assessments: ABC rated by caregiver at each visit; CGI severity and improvement rated by clinician at each visit, CY- BOCS (compulsion scale only, weeks 0, 4, and 8), administrator/rater NR; Pediatric QoL Inventory, Caregiver Strain Questionnaire assessed at baseline and week 8. Simpson-Angus Scale, Barnes Akathisia Rating Scale, Abnormal Involuntary Movement Scale used by clinician to rate adverse events Groups: G1: aripiprazole G2: placebo Co-interventions held stable during treatment: All psychotropic medications discontinued prior to study; lorazepam or alprazolam, sleep aids, diphenhydramine, benztropine, propranolol administered at investigators discretion Frequency of contact during study: Weekly clinic visits; telephone contact at week 7 Concomitant therapies, %: Analgesics/anti-pyretics: G1: 19.1 G2: 22.0 Hypnotics/sedatives: G1: 2.1 G2: 12.0 N at enrollment:* Inclusion/ Exclusion Criteria/ Population Inclusion criteria: • Autistic disorder diagnosis (DSM-IV, ADI- R) and demon-strated tantrums, aggression, self- injurious behavior, or a combination thereof • CGI-S score ≥ 4 at screening and baseline • ABC irritability score ≥ 18 at screening and baseline • Weight ≥ 15 kg • Age 6-17 years Exclusion criteria: • Current diagnosis of bipolar disorder, psychosis, schizophrenia, major depression, or fragile X syndrome • Diagnosis of another disorder on the autism spectrum including PDD- NOS, Asperger syndrome, Rett syndrome, or childhood disintegrative disorder • History of neuroleptic malignant syndrome • Significant risk for suicide • Seizure in past year • History of severe head trauma or stroke • History or evidence of unstable medical conditions • Clinically significant lab or diagnostic test result • Demonstrated resistance to antipsychotic medication or allergy/ hypersensitivity to aripiprazole • Unstable/inconsistent non-pharmacologic therapies Age 6-17y, mean ± SD: G1: 9.7 ± 3.2 C-74 Baseline Measures Outcomes G1c: -4.4 G2: -2.0 G1a/G2: P = NS G1a/G2: P = NS G1a/G2: P = NS Modifiers: NR Overall ratings:* CGI-S, mean: G1: 4.9 (n=40) G2: 4.8 (n=40) Serum prolactin, ng/ml, mean: G1: 9.8 G2: 6.8 QTcF interval, milliseconds, mean: G1: 377.6 G2: 376.3 Social skills: ABC lethargy/social withdrawal score, mean: G1: 19.9 G2: 18.1 Communication/ language: ABC inappropriate speech score, mean: G1: 7.0 G2: 7.0 Repetitive behavior: ABC stereotypy score, mean: G1: 11.9 G2: 10.7 Problem behavior: ABC irritability score, mean: G1: 29.6 G2: 30.8 ABC hyperactivity score, mean: G1: 34.1 G2: 34.7 CY-BOCS score (compulsions only), mean: G1: 12.8 (n=43) G2: 13.7 (n=44) Overall ratings: CGI-I at week 8, LOCF, efficacy sample, %: Very much/much improved: G1: 67 G2: 16 Minimally improved: G1: 15 G2: 20 No change: G1:13 G2:45 Minimally worse: G1:4 G2:10 Much/very much worse: G1: 0 G2: 8 CGI-I score, week 8, mean: G1: 2.2 G2: 3.6 G1/G2: P < 0.001 LSQ mean treatment difference (95% CI): -1.4 (-1.9,-1.0) CGI-S, week 8, mean change: G1: -1.2 (n=40) G2: -0.4 (n=40) G1/G2: P < 0.001 LSQ mean treatment difference (95% CI): -0.8 (-1.2,-0.4) Serum prolactin, ng/ml, week 8, mean change: G1: -6.3 G2: 1.6 G1/G2: P < 0.001 Weight gain, week 8, % G1: 28.9 G2: 6.1
Evidence Table. Therapies for children with ASD (continued) Study Inclusion/ Exclusion Description Intervention Criteria/ Population Wyeth (1) G1: 47 G2: 8.8 ± 2.6 G2: 51 Age 6-12y, n (%): G1: 37 (78.7) G2: 46 (90.2) Owen et al., 2009 N at follow-up: Mental age: (continued) G1: 39 NR Design: G2: 36 Gender, n (%): Double-blind, Male: RCT, permuted G1 :42 (89.4) block randomiza- G2: 44 (86.3) tion; multicenter Race/ethnicity, n (%): study White: Note: G1: 32 (68.1) See related study G2: 41 (80.4) Marcus et al., Black: 2009 G1: 11 (23.4) G2: 7 (13.7) Asian: G1: 2 (4.3) G2: 0 Other: G1: 2 (4.3) G2: 3 (5.9) SES: Maternal education: NR Household income: NR Diagnostic approach: In Study Diagnostic tool/method: ADI-R Diagnostic category, n (%): G1: Autistic disorder: G1: 47 (100) G2: 51 (100) PDD-NOS: G1: 0 G2: 0 Asperger syndrome: G1: 0 G2: 0 Other characteristics: Weight, kg ± SD: G1: 43.9 ± 19.2 G2: 40.6 ± 18.9 C-75 Baseline Measures Outcomes G1/G2: P < 0.01 QTcF interval, milliseconds, week 8, mean change: G1: 0.6 G2: 4.5 G1/G2: P = 0.381 Social skills: ABC lethargy/ social withdrawal score, week 8, mean change: G1: -7.9 G2: -6.2 G1/G2: P = NS Communication/ language: ABC inappropriate speech score, week 8, mean change: G1: -2.5 G2: -0.4 G1/G2: P < 0.001 LSQ mean treatment difference (95% CI): -2.0 (-3.1,-1.0) Repetitive behavior: ABC stereotypy score, 8 weeks, mean change: G1: -4.8 G2: -2.0 G1/G2: P < 0.001 LSQ mean treatment difference (95% CI): -2.9 (-4.5,-1.2) Problem behavior: ABC irritability score, 8 weeks, mean change: G1: -12.9 G2: -5.0 G1/G2: P < 0.001 LSQ mean treatment difference (95% CI): -7.9 (-11.7,-4.1)
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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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1443. Holburn CS. Counter the mistr
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1473. Horner RH, Carr EG, Strain PS
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1504. Hughes C, Soares-Boucaud I, H
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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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2267. McHale SM, Olley JG, Marcus L
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2296. Merlo LJ, Lehmkuhl HD, Geffke
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2325. Minderaa RB, Anderson GM, Vol
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2354. Montgomery JM, Duncan CR and
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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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2618. Paul C, Williams KE, Riegel K
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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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2704. Poon L, Partika N and Bolman
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2734. Prizant BM. Speech-language p
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2764. Rapp JT, Vollmer TR, St. Pete
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2792. Reed P, Broomfield L, McHugh
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2819. Remington G, Sloman L, Konsta
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2849. Ringdahl JE, Kitsukawa K, And
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2877. Rogers SJ. Interventions that
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2908. Rossignol DA. Novel and emerg
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2939. Rutter M, Kreppner J, Croft C
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2967. Sandt D. Social Stories for S
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2994. Scanlon K. Art therapy with a
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3023. Schneider CK, Melmed RD, Bars
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3054. Schwartz IS, Sandall SR, Garf
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3085. Shafer MS, Egel AL and Neef N
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3115. Shipley-Benamou R, Lutzker JR
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3143. Siller M and Sigman M. The be
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3173. Smith C, Felce D, Jones E, et
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3202. Snyder A, Bossomaier T and Mi
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3230. Spero MH. The emancipation of
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3259. Stephens CE. Spontaneous imit
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3289. Strambi M, Longini M, Hayek J
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3318. Suzumura K. How an autistic b
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3346. Tager-Flusberg H and Calkins
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3376. Taylor I, O’Reilly M and La
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3407. Thunberg G, Ahlsen E and Sand
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3435. Trembath D, Balandin S, Toghe
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3464. Turner-Brown LM, Perry TD, Di
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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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