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Cited by 84Autism Spectrum Disorder ResearchBehavioral and Psychological StudiesMeta-analysis and systematic reviews

Adverse event reporting in intervention research for young autistic children

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Bottema-Beutel, Kristen, Crowley, Shannon, Sandbank, Micheal, Woynaroski, Tiffany G·2021·Autism
DOI 10.1177/1362361320965331PMC PMC7870528
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Abstract

Our team examined 150 reports on group-design, non-pharmacological interventions for young autistic children, to determine the prevalence of adverse event reporting. We found that only 11 studies mentioned adverse events; one indicated adverse events occurred, and an additional three indicated adverse effects occurred (i.e. adverse events that could be attributed to the intervention). We also coded reasons for participant withdrawal and found that of the 54 studies that reported reasons for withdrawal, 10 studies reported reasons that could be categorized as adverse events, 8 reported reasons that could be categorized as adverse effects, and an additional 12 studies reported reasons that were too vaguely described to determine adverse event status. We recommend that autism intervention researchers make concerted efforts to monitor, classify, and report adverse events so that practitioners, policy-makers, and families are better equipped to weigh potential benefits of interventions against potential harms. Lay abstract: In this study, we looked at published research on interventions for young autistic children that did not involve administering medication. We were interested in determining how often studies reported on whether adverse events (i.e. physical or psychological distress to the participants) or adverse effects (i.e. adverse events that are thought to be caused by the intervention) had occurred. We found that of the 150 reports we examined, only 11 mentioned adverse events. One of these studies reported adverse events occurred, and three reported that adverse effects occurred. We also reviewed the studies to examine the reasons that were given to explain why any participants dropped out of the intervention (termed “withdrawal”), to determine if any of these reasons could be considered adverse events or adverse effects. Fifty-four studies described reasons for withdrawal, and 10 of these studies had reasons that could be categorized as an adverse event, 8 studies had reasons that could be categorized as an adverse effect, and an additional 12 studies had reasons that were too vaguely described to determine whether they were adverse events or not. We recommend that autism intervention researchers develop more systematic methods of looking for and reporting adverse events and effects, so that professionals and families can be better informed when choosing to enroll their autistic children in interventions.

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  • Adequately monitoring adverse events in clinical trials and clinical programs is a way to ensure an intervention is doing more good than harm.

    “Adequately monitoring these and other adverse events in clinical trials and clinical programs is yet another way to ensure an intervention is doing more good than harm (Bottema-Beutel et al., 2021a; Dawson & Fletcher-Watson, 2021)”

    From Neurodiversity and Autism Intervention: Reconciling Perspectives Through a Naturalistic Developmental Behavioral Intervention Framework (2022) · cites this paper as Bottema-Beutel et al., 2021a

    The Monitoring and Reporting Adverse Events section recommends systematic monitoring in intervention research, and the Conclusion says better reporting helps stakeholders weigh potential harms against benefits. The paper does not specifically address monitoring in clinical programs, and it describes monitoring as informing that judgment rather than ensuring an intervention does more good than harm. (LLM, conf=0.84)

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  • Potential adverse effects of standard interventions have rarely been investigated.

    “the potential adverse effects of standard interventions have been rarely investigated.”

    From Rethinking psychological interventions in autism: Toward a neurodiversity‐affirming approach. (2025) · cites this paper as Bottema-Beutel et al., 2021

    The Results report that only 11 of 150 intervention reports for young autistic children mentioned adverse events, and none described systematic monitoring. The Discussion likewise says researchers generally were not actively seeking adverse events. This supports the claim within that specific population and research area, but not its unqualified reference to standard interventions generally. (LLM, conf=0.84)

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  • Interventions often aim to change the individuals rather than accommodate their needs.

    “interventions often aim to change the individuals rather than accommodate their needs”

    From Rethinking psychological interventions in autism: Toward a neurodiversity‐affirming approach. (2025) · cites this paper as Bottema-Beutel et al., 2021

    The Conclusion (page unavailable) criticizes treating no longer meeting autism diagnostic criteria as an ‘optimal outcome,’ which supports the concern that some approaches prioritize changing autistic people. But it says that literature does not explicitly examine interventions, and it does not establish that interventions often pursue change rather than accommodation. (LLM, conf=0.82)

    Experimental — accuracy not yet measured

  • Autistic individuals may be less able to report issues due to the nature of their autistic condition.

    “autistic individuals may be less able to report issues due to the nature of their autistic condition”

    From Rethinking psychological interventions in autism: Toward a neurodiversity‐affirming approach. (2025) · cites this paper as Bottema-Beutel et al., 2021

    The paper’s discussion of facilitated communication (section labeled Abstract; page unavailable) says that some autistic people previously lacked a reliable means of communicating. That lends limited support to difficulty reporting issues, but the paper does not say that autistic individuals generally have this difficulty or attribute it to autism itself. (LLM, conf=0.73)

    Experimental — accuracy not yet measured

  • Adverse events are seldom considered in research on non-pharmacological autism interventions, making it difficult to assess even immediate harmful impacts of ABA.

    “Unfortunately, adverse events are seldom considered in research on non-pharmacological autism interventions (Bottema-Beutel et al., 2021a; Dawson & Fletcher-Watson, 2021), making it difficult to assess even immediate harmful impacts of ABA.”

    From Neurodiversity and Autism Intervention: Reconciling Perspectives Through a Naturalistic Developmental Behavioral Intervention Framework (2022) · cites this paper as Bottema-Beutel et al., 2021a

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Research works printed but not linked: 48

  1. American Occupational Therapy Association. (2015). Occupational therapy code of ethics (2015). American Journal of Occupational Therapy, 69(Suppl. 3), 6913410030. 26713949
  2. American Psychological Association. (2016). Revision of ethical standard 3.04 of the “Ethical Principles of Psychologists and Code of Conduct” (2002, as amended 2010). American Psychologist, 71, 900. 28032786
  3. Bearss K, Johnson C, Smith T, Lecavalier L, Swiezy N, Aman M, … Sukhodolsky DG (2015). Effect of parent training vs parent education on behavioral problems in children with autism spectrum disorder: A randomized clinical trial. Journal of the American Medical Association, 313(15), 1524– 1533. 25898050 PMC9078140
  4. Bieleninik Ł, Geretsegger M, Mössler K, Assmus J, Thompson G, Gattino G, … & Suvini F (2017). Effects of improvisational music therapy vs enhanced standard care on symptom severity among children with autism spectrum disorder: The TIME-A randomized clinical trial. Journal of the American Medical Association, 318, 525– 535. 28787504 PMC5817481
  5. Bottema-Beutel K, Crowley S, Sandbank M, & Woynaroski TG (2020). Research review: Conflicts of interest (COIs) in autism early intervention research–a meta-analysis of COI influences on intervention effects. Journal of Child Psychology and Psychiatry. Advance online publication. PMC7606324 32353179
  6. Clionsky LN (2012). Child directed interaction training for young children with autism spectrum disorders: The impact on child language, social skills, adaptive skills, and problematic behaviors (Unpublished doctoral dissertation). University of Florida, Gainesville, FL.
  7. Divan G, Hamdani SU, Vajartkar V, Minhas A, Taylor C, Aldred C, … Patel V (2015). Adapting an evidence-based intervention for autism spectrum disorder for scaling up in resource-constrained settings: The development of the PASS intervention in South Asia. Global Health Action, 8(1), 27278. 26243710 PMC4524889
  8. Eldevik S, Hastings RP, Hughes JC, Jahr E, Eikeseth S, & Cross S (2009). Meta-analysis of early intensive behavioral intervention for children with autism. Journal of Clinical Child & Adolescent Psychology, 38(3), 439– 450. 19437303
  9. Favell JE, Azrin NH, Baumeister AA, Carr EG, Dorsey MF, Forehand R, … Romanczyk RG (1982). The treatment of self-injurious behavior. Behavior Therapy, 13(4), 529– 554.
  10. French L, & Kennedy EM (2018). Annual research review: Early intervention for infants and young children with, or at-risk of, autism spectrum disorder: A systematic review. Journal of Child Psychology and Psychiatry, 59(4), 444– 456. 29052838
  11. Fridenson-Hayo S, Berggren S, Lassalle A, Tal S, Pigat D, Meir-Goren N, … & Golan O (2017). ‘Emotiplay’: A serious game for learning about emotions in children with autism: Results of a cross-cultural evaluation. European Child & Adolescent Psychiatry, 26, 979– 992. 28275895
  12. Hanley GP (2010). Toward effective and preferred programming: A case for the objective measurement of social validity with recipients of behavior-change programs. Behavior Analysis in Practice, 3(1), 13– 21. PMC3004679 22479668
  13. Hardan AY, Gengoux GW, Berquist KL, Libove RA, Ardel CM, Phillips J, … & Minjarez MB (2015). A randomized controlled trial of Pivotal Response Treatment Group for parents of children with autism. Journal of Child Psychology and Psychiatry, 56(8), 884– 892. 25346345
  14. Harris SL, Handleman JS, Gill MJ, & Fong PL (1991). Does punishment hurt? The impact of aversives on the clinician. Research in Developmental Disabilities, 12(1), 17– 24. 2017584
  15. Ichikawa K, Takahashi Y, Ando M, Anme T, Ishizaki T, Yamaguchi H, & Nakayama T (2013). TEACCH-based group social skills training for children with high-functioning autism: A pilot randomized controlled trial. BioPsychoSocial Medicine, 7, 14. 24083413 PMC3850504
  16. Ingersoll B, Wainer AL, Berger NI, Pickard KE, & Bonter N (2016). Comparison of a self-directed and therapist-assisted telehealth parent-mediated intervention for children with ASD: A pilot RCT. Journal of Autism and Developmental Disorders, 46, 2275– 2284. 26922192
  17. Ioannidis JP (2009). Adverse events in randomized trials: Neglected, restricted, distorted, and silenced. Archives of Internal Medicine, 169(19), 1737– 1739. 19858427
  18. Ioannidis JP, Evans SJ, Gøtzsche PC, O’neill RT, Altman DG, Schulz K, & Moher D (2004). Better reporting of harms in randomized trials: An extension of the CONSORT statement. Annals of Internal Medicine, 141(10), 781– 788. 15545678
  19. LaGasse AB (2014). Effects of a music therapy group intervention on enhancing social skills in children with autism. Journal of Music Therapy, 51, 250– 275. 25053766
  20. Leape LL (2002). Reporting of adverse events. New England Journal of Medicine, 347(20), 1633– 1638. 12432059
  21. Lichstein KL, & Schreibman L (1976). Employing electric shock with autistic children. Journal of Autism and Childhood Schizophrenia, 6(2), 163– 173. 786974
  22. Lilienfeld SO (2007). Psychological treatments that cause harm. Perspectives on Psychological Science, 2(1), 53– 70. 26151919
  23. Lilienfeld SO, Lynn SJ, & Lohr JM (Eds.). (2003). Science and pseudoscience in clinical psychology. New York: Guilford.
  24. Lovaas OI (1987). Behavioral treatment and normal educational and intellectual functioning in young autistic children. Journal of Consulting and Clinical Psychology, 55, 3– 9. 3571656
  25. Lovaas OI, Schaeffer B, & Simmons JQ (1965). Building social behavior in autistic children by use of electric shock. Journal of Experimental Research in Personality, 1, 99– 105.
  26. Malow BA, Adkins KW, Reynolds A, Weiss SK, Loh A, Fawkes D, … & Clemons T (2014). Parent-based sleep education for children with autism spectrum disorders. Journal of Autism and Developmental Disorders, 44, 216– 228. 23754339 PMC3818449
  27. Orinstein A, Tyson KE, Suh J, Troyb E, Helt M, Rosenthal M, … Schultz RT (2015). Psychiatric symptoms in youth with a history of autism and optimal outcome. Journal of Autism and Developmental Disorders, 45(11), 3703– 3714. 26155764 PMC4609588
  28. Page CE (2012). The social and emotional benefits of therapeutic riding on children with autism spectrum disorder (Unpublished doctoral dissertation). Institute of Transpersonal Psychology, Palo Alto, CA.
  29. Peryer G, Golder S, Junqueira D, Vohra S, & Loke YK (2019). Chapter 19: Adverse effects In Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, & Welch VA (Eds), Cochrane handbook for systematic reviews of interventions version 6.0 (updated July 2019). Cochrane Retrieved from https://training.cochrane.org/handbook/current/chapter-19
  30. Pitrou I, Boutron I, Ahmad N, & Ravaud P (2009). Reporting of safety results in published reports of randomized controlled trials. Archives of Internal Medicine, 169(19), 1756– 1761. 19858432
  31. Reichow B, Hume K, Barton EE, & Boyd BA (2018). Early intensive behavioral intervention (EIBI) for young children with autism spectrum disorders (ASD). The Cochrane Database of Systematic Reviews, 5(5), CD009260 10.1002/14651858.CD009260.pub3 29742275 PMC6494600 · DOI · Paper page
  32. Schroll JB, Maund E, & Gøtzsche PC (2012). Challenges in coding adverse events in clinical trials: A systematic review. PLoS One, 7(7), e41174. 22911755 PMC3401103
  33. Siegel B (1995). Assessing allegations of sexual molestation made through facilitated communication. Journal of Autism and Developmental Disorders, 25(3), 319– 326. 7559297
  34. Silva LM, Schalock M, Gabrielsen KR, Budden SS, Buenrostro M, & Horton G (2015). Early intervention with a parent-delivered massage protocol directed at tactile abnormalities decreases severity of autism and improves child-to-parent interactions: A replication study. Autism Research and Treatment, 2015, 904585. 25878901 PMC4387906
  35. Sallows GO, & Graupner TD (2005). Intensive behavioral treatment for children with autism: Four-year outcome and predictors. American Journal on Mental Retardation, 110, 417– 438. 16212446
  36. Salt J, Shemilt J, Sellars V, Boyd S, Coulson T, & McCool S (2002). The Scottish Centre for Autism preschool treatment programme. II: The results of a controlled treatment outcome study. Autism, 6, 33– 46. 11918108
  37. Sampanthavivat M, Singkhwa W, Chaiyakul T, Karoonyawanich S, & Ajpru H (2012). Hyperbaric oxygen in the treatment of childhood autism: A randomised controlled trial. Diving and Hyperbaric Medicine, 42, 128– 133. 22987458
  38. Solomon R, Van Egeren LA, Mahoney G, Huber MSQ, & Zimmerman P (2014). PLAY Project Home Consultation intervention program for young children with autism spectrum disorders: A randomized controlled trial. Journal of Developmental and Behavioral Pediatrics, 35, 475– 485. 25264862 PMC4181375
  39. Smith T, Groen AD, & Wynn JW (2000). Randomized trial of intensive early intervention for children with pervasive developmental disorder. American Journal on Mental Retardation, 105, 269– 285. 10934569
  40. Srinivasan SM, Kaur M, Park IK, Gifford TD, Marsh KL, & Bhat AN (2015). The effects of rhythm and robotic interventions on the imitation/praxis, interpersonal synchrony, and motor performance of children with autism spectrum Disorder (ASD): A pilot randomized controlled trial. Autism Research and Treatment, 2015, 736516. 26793394 PMC4697072
  41. Strain PS (2017). Four-year follow-up of children in the LEAP randomized trial: Some planned and accidental findings. Topics in Early Childhood Special Education, 37(2), 121– 126.
  42. Tellegen CL, & Sanders MR (2014). A randomized controlled trial evaluating a brief parenting program with children with autism spectrum disorders. Journal of Consulting and Clinical Psychology, 82, 1193– 1200. 24979315
  43. Thompson GA, McFerran KS, & Gold C (2014). Family-centred music therapy to promote social engagement in young children with severe autism spectrum disorder: A randomized controlled study Child: Care, Health and Development, 40, 840– 852. 24261547
  44. Wallace BC, Small K, Brodley CE, Lau J, & Trikalinos TA (2012, 1). Deploying an interactive machine learning system in an evidence-based practice center: Abstrackr. In Proceedings of the 2nd ACM SIGHIT international health informatics symposium (pp. 819– 824).
  45. Weiner RH, & Greene RL (2014). Intention-based therapy for autism spectrum disorder: Promising results of a wait-list control study in children. EXPLORE: The Journal of Science and Healing, 10, 13– 23. 24439092
  46. Whitehouse AJ, Granich J, Alvares G, Busacca M, Cooper MN, Dass A, … & Anderson A (2017). A randomised controlled trial of an iPad-based application to complement early behavioural intervention in autism spectrum disorder. Journal of Child Psychology and Psychiatry, 58, 1042– 1052. 28543302
  47. Williams BT, Gray KM, & Tonge BJ (2012). Teaching emotion recognition skills to young children with autism: A randomised controlled trial of an emotion training programme. Journal of Child Psychology and Psychiatry, 53, 1268– 1276. 22881991
  48. Yu B (2016). Bilingualism as conceptualized and bilingualism as lived: A critical examination of the monolingual socialization of a child with autism in a bilingual family. Journal of Autism and Developmental Disorders, 46(2), 424– 435. 26519327

Cited by

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Authors
Bottema-Beutel, K., Crowley, S., Sandbank, M., & Woynaroski, T. G.
Affiliations
  • Boston College, USA
  • Boston College (US)
  • The University of Texas at Austin (US)
  • Vanderbilt University Medical Center (US)
ORCID
Venue
Autism
Publisher
SAGE Publications
Published
2020-10-19
Volume
25
Issue
2
Pages
322-335
ISSN
  • 1362-3613 (ISSN-L)
  • 1461-7005
DOI
10.1177/1362361320965331
PMC
PMC7870528
OpenAlex
W3093300669
Cited by
84
References
64
Citations by year
2026: 14 · 2025: 15 · 2024: 21 · 2023: 11 · 2022: 13 · 2021: 9 · 2013: 1
FWCI
4.43
Type
journal article
Language
en
Open access
Licence
journals.sagepub.com/page/policies/text-and-data-mining-license (tdm)
Locations
  • Autism (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • National Institutes of Health (T32 MH064913)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (U54HD083211)
  • National Institute on Deafness and Other Communication Disorders (1R21DC016144, R03DC017013- 1)
Topics
  • Life Sciences › Neuroscience › Cognitive Neuroscience › Autism Spectrum Disorder Research
  • Social Sciences › Psychology › Developmental and Educational Psychology › Behavioral and Psychological Studies
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Keywords
adverse event reporting, adverse effects, autism intervention, non-pharmacological treatment, participant withdrawal, harms of interventions, benefit-harm assessment, research reporting practices
MeSH terms
Autism Spectrum Disorder, Autistic Disorder, Child, Humans

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