Therapies for Children With Autism Spectrum Disorders

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C-Irritability 21.2-25.5) arms. Decreases in ABC-C Irritability were significantly greater for the risperidone arms in both studies, which saw improvements of 12.1-14.9, compared with the placebo arms, which saw improvements of 3.6-6.5. Similar improvements for a second measure of challenging behavior, the ABC-C Hyperactivity subscale, which indexes noncompliance as well as hyperactivity, were also seen in both trials. Baseline ratings of hyperactivity were similar, with decreases significantly greater for risperidone compared with placebo ( 14.8-14.9, in comparison to 4.7-7.4). The RUPP study also reported a number of other outcomes that may correlate with challenging behavior, including the Ritvo-Freeman Real Life Rating Scale Affectual Reactions subscale, which includes abrupt changes in mood, temper tantrums, and crying, the VABS Maladaptive Behavior Domain, and quantitative ratings of parent-rated target symptoms, each of which showed significant improvements in the risperidone group. 204,207 Secondary outcomes in the two RCTs of risperidone included measures of repetitive behavior. Both studies included the ABC-C Stereotypy Subscale, which showed greater response in the risperidone arm. Baseline ratings of stereotypy were similar across risperidone and placebo arms. Decreases in ABC-C-Stereotypy were significantly greater for risperidone in one RCT (4.8 vs. 1.7) 206 but would not have been significant after correction for multiple testing in the other RCT (4.3 vs. 2.4). 211 One study 204,206 also used the Children’s Yale-Brown Obsessive Compulsive Scale-PDD version to assess repetitive behavior, finding no baseline differences between the groups but a significantly greater decrease in the risperidone compared with placebo arms (3.9 vs. 1.0). A number of other outcomes were measured in these studies, but none outside of challenging behavior and repetitive behavior would have yielded statistically significant findings once corrected for multiple comparisons. Two additional RCTs were identified that did not provide specific numerical ratings on either challenging behavior or repetitive behavior. 203,212 One of these was an eight-week drug discontinuation RCT with risperidone and placebo arms 203 after positive response during four months of open label risperidone treatment following the RUPP risperidone RCT. 206 This publication did not provide quantitative outcome data but instead indexed “relapse” using a composite measure of ABC-C-Irritability and clinician ratings of CGI-I, 203 finding significantly less “relapse” in the risperidone arm (two of 16 subjects) in comparison to the placebo arm (10 of 16 subjects). The last RCT was a six-month RCT with risperidone and placebo arms that used a variety of general rating scales to assess response and provided quantitative outcome data on only some of these scales, 212 with the primary outcome measures being parent ratings on the Childhood Autism Rating Scale and clinician ratings on the Children’s Global Assessment Scale. The study only reports Childhood Autism Rating Scale median ratings for those participants with at least a 20 percent response. 212 Average ratings on the Children’s Global Assessment Scale were similar in the risperidone (29.8) and placebo (32.7) arms with more improvement in the risperidone (11.1) than placebo (2.5) arms. All of the risperidone RCTs also provided data on adverse events or side effects (Table 19). All studies reported on weight gain, 202,203,206,210-212 which was greater in the risperidone arms (2.7-2.8 kg) than in the placebo arms (0.8-1.7 kg), with a statistically significant difference reported in two of the studies. 202,206,210,211 Three of the RCTs 202,203,206,210,211 provided data on other adverse events in both the risperidone and placebo arms. Somnolence or drowsiness was the most common adverse event in two of these studies, occurring in 53 of 89 subjects in risperidone arms and nine of 91 subjects in placebo arms. 202,206,210,211 These studies also reported 62
that this somnolence improved over time. 202,206,210,211 Both these studies also reported more extrapyramidal symptoms, including tremor, dyskinesia, and rigidity, in the risperidone arm in comparison with the placebo arm, but these events were categorized and summed differently between the two studies and did not clearly show a statistically significant difference between treatment arms. 202,206,210,211 The RUPP study 206 also reported a greater rise in prolactin levels in the risperidone arm (27.7 ng/mL) compared with the placebo arm (0.8 ng/mL); 209 although it did not report clinical events such as gynecomastia or galactorrhea that could be related to elevated prolactin levels. 203,206 The RUPP study specifically assessed cognitive function in a subset of subjects and found no worsening and some evidence of improvement on risperidone that would not be statistically significant after correction for multiple testing. 201,206 Table 17. Outcomes of RCTs of antipsychotic medications for challenging and repetitive behaviors Author, year, country Groups, N enrollment / N final Study quality RUPP 203 2005, US G1:risperidone, 16/16 G2:placebo, 16/16 Quality: Fair Shea, et al. 210,211 2004, Canada G1: risperidone, 41/39 G2: placebo, 39/38 Quality: Fair Mean age, years ± SD NR, subset of subjects from RUPP 2002 G1: 7.6 ± 2.3 G2: 7.3 ± 2.3 Mean IQ ±SD Outcome measure/Baseline scores, mean ±SD NR, subset of subjects from RUPP 2002 G1: ≥85:3 71-84:6 50-70:12 35-49:10 G2: ≥85:11 71-84:4 50-70:8 35-49:12 63 Overall, ABC-C-Irritability: 27.6 ± 6.1 Overall, ABC-C-Hyperactivity/ Noncompliance: 34.4 ± 8.7 Relapse: 2 consecutive weeks of 25% increase on ABC-C-Irritability and CGI-I of “much worse” or “very much worse” ABC-C-Irritability: G1: 18.9 ± 8.8 G2: 21.2 ± 9.7 ABC-C-Hyperactivity/ Noncompliance: G1: 27.3 ± 9.7 G2: 30.9 ± 8.8 ABC-Stereotypic behavior: G1: 7.9 ± 5.0 G2: 8.1 ± 5.6 Outcome measure/Posttreatment scores a , mean ± SD Relapse: G1: 2/16 (12.5%) G2: 10/16 (62.5%) p=0.01 Change in: ABC-C-Irritability: G1: -12.1 ± 5.8 G2: -6.5 ± 8.4 p ≤ 0.001 ABC-C-Hyperactivity/ Noncompliance: G1: -14.9 ± 6.7 G2: 7.4 ± 9.7 p ≤ 0.001 ABC-Stereotypic behavior: G1: -4.3 ± 3.8 G2: -2.4 ± 4.0 p ≤ 0.05
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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
Page 45 and 46: Table 4. Description of allied heal
Page 47 and 48: Key Questions and Analytic Framewor
Page 49 and 50: Chapter 4 discusses the results in
Page 51 and 52: Methods This chapter documents proc
Page 53 and 54: • Did not present aggregated resu
Page 55 and 56: Additional behavioral interventions
Page 57 and 58: 1. Did the study employ a group des
Page 59 and 60: Scoring: Studies minimally had to h
Page 61 and 62: These ratings of applicability do n
Page 63 and 64: Figure 2. Disposition of articles a
Page 65 and 66: • ABA-based approaches including
Page 67 and 68: education, children in the intensiv
Page 69 and 70: abilities. This finding is further
Page 71 and 72: Table 10. Outcomes of early intensi
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Page 75 and 76: interaction with peers; outcome mea
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Page 79 and 80: Table 12. Outcomes of RCTs assessin
Page 81 and 82: Schedule for Affective Disorders an
Page 83 and 84: SCAS-P=Spence Child Anxiety Scale-P
Page 85 and 86: Summary of the literature. Jarusiew
Page 87 and 88: Table 14. Overview of educational s
Page 89 and 90: on the Ankara Developmental Screeni
Page 91 and 92: Checklist scores decreased by 8.4 f
Page 93 and 94: Table 15. Outcomes of studies asses
Page 95: evaluated the effects of risperidon
Page 99 and 100: Table 17. Outcomes of RCTs of antip
Page 101 and 102: Serotonin Reuptake Inhibitors SRIs
Page 103 and 104: One prospective case series of esci
Page 105 and 106: Most participants were recruited fr
Page 107 and 108: Dietary and Other Medical Intervent
Page 109 and 110: Summary of the literature-other int
Page 111 and 112: withdrew after the first six weeks;
Page 113 and 114: therefore described separately belo
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Page 119 and 120: Table 25. Overview of CAM studies a
Page 121 and 122: Teacher and Parent Scales, behavior
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Page 127 and 128: showed diminished response to escit
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Page 131 and 132: contrast group (n=18) on three meas
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Page 135 and 136: Few studies directly comparing the
Page 137 and 138: Strength of evidence. The strength
Page 139 and 140: While individual studies of CBT and
Page 141 and 142: Table 32. Summary of results of edu
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Page 145 and 146: 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
Page 619 and 620:
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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