Therapies for Children With Autism Spectrum Disorders

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Evidence Table. Therapies for children with ASD (continued) Study Description Intervention Author: Granpeesheh et al., 2009 Country: US Practice setting: Specialty treatment center Intervention setting: Community Enrollment period: 1995 to 2007 Funding: NR Author industry relationship disclosures: None Design: Retrospective case series Author: Handen, et al., 2009 Country: US Practice setting: Academic Intervention: Early Intensive Behavioral Intervention Assessments: WISC-R and WISC-III, SB-FE, MPS, LIPS-R, MESL (AGS edition), BSID-II, DAS Groups: G1: intervention Provider: NR Measure of treatment fidelity reported: No Co-interventions held stable during treatment: NR Concomitant therapies: NR N at enrollment: G1: 38 N at follow-up: G1: 38 Intervention: Randomized, doubleblind, placebo-controlled, parallel groups, involving 12 centers in the US. Oral human immuneglobulin (IGOH; Oralgam), 140, 420, or 840 mg/day Inclusion/ Exclusion Criteria/ Population Inclusion criteria: • No longer presented with developmental delay in any area of functioning of which author is aware • Placed in regular education classrooms and were earning passing grades without any special assistance • Reason for discharge from author’s treatment was the absence of any apparent need for treatment • Agreement of criteria must be met between a minimum of two senior clinicians who were familiar with the course and outcome of a patient’s treatment • Patient record had to contain cognitive testing within 6 months of start of ABA services and within 6 months of stopping ABA services Exclusion criteria: • See inclusion criteria Age, months ± SD (range): G1: 40.32 ± 7.27 (24-55) Mental age: NR Gender: NR Race/ethnicity: NR SES: Maternal education: NR Household income: NR Diagnostic approach: Referral Diagnostic tool/method: NR Diagnostic category, %: Autism: 100 Other characteristics: NR Inclusion criteria: • Met diagnostic criteria for autism per DSM-IV, corroborated by ADI-R • CGI severity scale > 3 (autistic symptoms) • History of chronic, persistent GI disturbance C-46 Baseline Measures Outcomes month follow-up (r = 0.63; P < 0.01)† Adaptive behavior: VABS composite score, mean ± SD (range): G1: 68.04 ± 7.79 (57-82) Educational/ cognitive/ academic attainment: IQ, mean ± SD (range): G1: 83.6 ± 19.15 (50-133) Adaptive behavior: VABS composite, mean ± SD (range): G1: 88.87 ± 11.02 (69-111) Educational/ cognitive/ academic attainment: IQ, mean ± SD (range): G1: 107.9 ± 9.59 (89-128) Harms: NR Modifiers: NR Overall ratings: CGI, physician rated, n (%): Very much or much improved: G1a: 3/29 (10.3) G1b: 9/26 (34.6) G1c: 5/28 (17.9)
Evidence Table. Therapies for children with ASD (continued) Study Inclusion/ Exclusion Baseline Description Intervention Criteria/ Population Measures Outcomes Intervention for 12 weeks (admini- (> 6 weeks duration) G2: 11/28 (39.3) setting: stered in divided doses of • One of following must be Minimally Clinic 3 capsules in the morning present: abnormal improved or Enrollment and 3 capsules in the gaseousness, bloating, unchanged: period: evening) or placebo or symptoms of G1a: 25/29 (86.2) NR A computerized system moderate-to-severe G1b: 14/26 (53.9) Funding: used to assign and verify abdominal pain or G1c: 21/28 (75.0) PediaMed 1:1:1:1 randomization, discomfort G2: 15/28 (53.6) Pharmaceuticals Author industry relationship disclosures: with subjects balanced by • No elective changes in site and age concurrent therapy Assessments: during the study MGIS (response to treat- Exclusion criteria: Minimally, much or very much worse: G1a: 1/29 (3.4) 2 of 7 Alarus Developmental International (1) PediaMed Pharmaceuticals (1) PRA International (1) Design: RCT ment after 12 weeks); • Evidence of a GI weekly, daily status of GI infection based on stool signs and symptoms laboratory tests at completed by parents baseline Behavioral measures • Known diagnosis of (ABC), CGI-I to assess other GI pathology the severity of behavioral • Current use of antibiotics symptom as completed by or antifungal parents and clinicians medications, chelation General safety and therapy, medication tolerability assessed affecting GI transit (stool Groups: softeners and bulking G1a: IGOH 140 mg/day agents were permitted if G1b: IGOH 420 mg/day constant doses were G1c: IGOH 840 mg/day used for ≥ 30 days prior G2: placebo to screening visit and no Co-interventions held changes in dosing was stable during treatment: planned during the Yes course of the study) Frequency of contact • Changes in diet during study: intervention within 30 2 weeks and 12 weeks days prior to the Concomitant therapies: screening visit NR • Changes in alternative N at enrollment: medical therapies G1a: 32 • DSM-IV diagnosis of a G1b: 31 pervasive developmental G1c: 31 disorder other than G2: 31 autism • Evidence of a seizure disorder, Fragile X syndrome, Tuberous Sclerosis Complex, liver or pancreatic disease, cystic fibrosis, or chronic infection G1b: 3/26 (11.5) G1c: 2/28 (7.1) G2: 2/28 (7.1) G1a/G1b/G1c/ G2: P = 0.5 CGI, parent rated, n (%): Very much or much improved G1a: 6/29 (20.7) G1b: 12/26 (46.2) G1c: 7/28 (25.0) G2: 16/29 (55.2) Minimally improved or unchanged: G1a: 21/29 (72.4) G1b: 12/26 (46.2) G1c: 17/28 (60.7) G2: 12/29 (41.4) Minimally, much, or very much worse: G1a: 2/29 (6.9) G1b: 2/26 (7.6) G1c: 4/28 (14.3) G2: 1/29 (3.4) G1a/G1b/G1c/ G2: P = 0.047 Handen, et al., N at follow-up: • Previous GI surgery with Responders to 2009 (continued) G1a: 27 the exception of fundop- treatment, MGIS, G1b: 23 lication, appendectomy, ITT population, n: G1c: 24 gastrostomy, endoscopy, G1a: 11/32 G2: 26 pyloromyotomy, or G1b: 9/31 herniorraphy G1c: 11/31 • Pregnancy G2: 14/31 • Participation in another G1/G2: P = 0.22 investigational study Dose-response C-47
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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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Page 187 and 188: Therapies for Children with ASD Sys
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Page 191 and 192: Evidence Table. Therapies for child
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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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Therapies for Children With Autism Spectrum Disorders

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