A Multisite Randomized Controlled Trial Comparing the Effects of Intervention Intensity and Intervention Style on Outcomes for Young Children With Autism - 03/06/21
, Paul Yoder, PhD b, Annette Estes, PhD c, Zachary Warren, PhD b, John McEachin, PhD d, Jeff Munson, PhD c, Marie Rocha, PhD a, Jessica Greenson, PhD c, Lisa Wallace, MS b, Elizabeth Gardner, PhD b, Geraldine Dawson, PhD e, Catherine A. Sugar, PhD f, Gerhard Hellemann, PhD f, Fiona Whelan, MS fRésumé |
For young children with autism spectrum disorders (ASD), high-quality single-blind randomized controlled trials of well-defined manualized interventions delivered 1:1 at intended fidelity have demonstrated significant effects on IQ, expressive language, receptive language, and autism severity.1-5 Although these different approaches have all demonstrated efficacy, their manuals and publications describe large differences among them in (1) intervention style (eg, adult-directed didactic vs naturalistic developmental/behavioral), and (2) intervention intensity (ie, hours of intervention per week). Although caregivers and practitioners need information about what style and intensity of early intervention is optimal for a given child, there have been no rigorously controlled comparative studies addressing these questions, which have major policy, practice, and funding implications for intervention delivery systems, professional training and practice, caregiver choice and learning, and children’s lives. Multiple previous intervention studies reported that autism symptom severity, severity of developmental delays, and treatment intensity predicted child outcomes. However, none of these studies used a randomized controlled trial (RCT) design.6-9 Although it is common for some interventions to be delivered 1:1 at intensities as high as 35 to 40 hours per week in keeping with Lovaas’s initial report, the costs and scarcity of such intensive treatment require supportive high quality evidence, providing one of the rationales for this study.10
Le texte complet de cet article est disponible en PDF.Abstract |
Objective |
This randomized, multisite, intent-to-treat study tested the effects of 2 levels of treatment intensity (number of hours) and 2 treatment styles on the progress of young children with autism spectrum disorder (ASD). We predicted that initial severity of developmental delay or autism symptoms would moderate the effects of intensity and style on progress in 4 domains: autism symptom severity, expressive communication, receptive language, and nonverbal ability.
Method |
A total of 87 children with ASD, mean age 23.4 months, were assigned to 1 of 2 intervention styles (naturalistic developmental/behavioral or discrete trial teaching), each delivered for either 15 or 25 hours per week of 1:1 intervention for 12 months by trained research staff. All caregivers received coaching twice monthly. Children were assessed at 4 timepoints. Examiners and coders were naive to treatment assignment.
Results |
Neither style nor intensity had main effects on the 4 outcome variables. In terms of moderating the effects of initial severity of developmental delay and of autism symptom severity, neither moderated the effects of treatment style on progress in any of the 4 domains. In terms of treatment intensity, initial severity moderated effect of treatment intensity on only 1 domain, namely, change in autism symptom severity; in a secondary analysis, this effect was found in only 1 site.
Conclusion |
Neither treatment style nor intensity had overall effects on child outcomes in the 4 domains examined. Initial severity did not predict better response to 1 intervention style than to another. We found very limited evidence that initial severity predicted better response to 25 vs 15 hours per week of intervention in the domains studied.
Clinical trial registration information |
Intervention Effects of Intensity and Delivery Style for Toddlers With Autism: clinicaltrials.gov/; NCT02272192
Le texte complet de cet article est disponible en PDF.Key Words : autism spectrum disorder, early intervention, Early Start Denver Model, early intensive behavioral intervention, treatment intensity
Plan
| This study was supported by the National Institute of Mental Health (NIMH)/the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) award number 1R01MH100030 (Sally J. Rogers, PI) as part of the Autism Centers of Excellence (ACE) Treatment Network and by the MIND Institute Intellectual and Developmental Disabilities Research Center U54HD079125 (Leonard Abbeduto, PI). The content is solely the responsibility of the authors and does not necessarily represent the official views of the funding agency. |
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| Dr. Hellemann served as the statistical expert for this research. |
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| Author Contributions |
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| Conceptualization: Rogers, Yoder |
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| Data curation: Munson, Greenson, Whelan |
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| Formal analysis: Yoder, Munson, Sugar, Hellemann |
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| Funding acquisition: Rogers |
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| Investigation: Rogers, Estes, McEachin, Wallace, Gardner, Sugar |
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| Methodology: Rogers, Yoder, Estes, McEachin, Greenson, Dawson, Hellemann |
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| Project administration: Rogers, Estes, Warren, Rocha, Greenson, Wallace, Gardner, Sugar |
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| Resources: Rogers, Estes, Warren |
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| Software: Munson, Hellemann, Whelan |
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| Supervision: Rogers, Estes, Warren, McEachin, Rocha, Greenson, Wallace, Gardner, Sugar, Hellemann |
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| Writing – original draft: Rogers, Yoder, Hellemann |
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| Writing – review and editing: Rogers, Yoder, Estes, Warren, McEachin, Munson, Rocha, Greenson, Wallace, Gardner, Dawson, Sugar, Hellemann |
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| ORCID |
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| Sally J. Rogers, PhD: 0000-0003-0755-2900 |
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| Annette Estes, PhD: 0000-0003-2687-4155 |
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| Zachary Warren, PhD: 0000-0001-9677-9386 |
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| John McEachin, PhD: 0000-0002-5673-6610 |
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| Marie Rocha, PhD: 0000-0001-7018-6427 |
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| Elizabeth Gardner, PhD: 0000-0003-2785-1385 |
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| Geraldine Dawson, PhD: 0000-0003-1410-2764 |
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| Catherine A. Sugar, PhD: 0000-0003-2804-7612 |
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| Gerhard Hellemann, PhD: 0000-0003-2449-7704 |
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| Disclosure: Dr. Rogers has received a University of British Columbia BC subcontract, grant funding from NICHD, the US Health Resources Services Administration (HRSA), the US Department of Education, and NIMH, royalties for published materials from Guilford Press, APPI Press, Springer Press, Wiley Press, and UC Extension Service, and honoraria for academic talks. Dr. Yoder has received grant funding from the National Institute on Deafness and Other Communication Disorders (NIDCD) and honoraria for academic talks unrelated to article content. Dr. Estes has received grant funding/the National Institutes of Health (NIH) subcontracts from NIMH, NICHD, and the NIH Brain Initiative Fellowship. She has served as a consultant to Motivity and has received honoraria for academic talks. Dr. Warren has received grant funding from the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Services (CMS), the US Department of Defense, HRSA, the Institute for Education Sciences (IES), NICHD, NIMH, Autism Speaks-the Autism Treatment Network, the Simons Foundation, and the Tennessee Department of Education. He has served as a consultant to Roche and Adaptive Technology Consulting and has received honoraria for academic talks unrelated to article content. Dr. McEachin has received book royalties from DRL Books and honoraria for invited addresses. Dr. Munson has received grant funding from NIMH, the National Institute of Allergy and Infectious Diseases (NIAID), and Children's Healthcare of Atlanta. Dr. Rocha has received grant support from IES, NICHD, NIMH, and HRSA and has served as a consultant for clinical services. Dr. Gardner has received grant funding from NICHD. Dr. Dawson has served as a member of the Scientific Advisory Boards of Janssen Research and Development, Akili, Inc., LabCorp, Inc., Roche Pharmaceutical Company, and Tris Pharma. She has served as a consultant to Apple, Gerson Lehrman Group, Guidepoint, Inc., Axial Ventures, Teva Pharmaceuticals, and is CEO of DASIO, LLC. She has received book royalties from Guilford Press, Oxford University Press, Springer Nature Press. She has held the following patent applications: 1802952, 1802942, 15141391, and 16493754. She has developed technology that has been licensed and she and Duke University have benefited financially. She has received research grants from NICHD, NIMH/the National Institute of Neurological Disorders and Stroke (NINDS), NIMH, the Simons Foundation Award, the Stylli Translation Neuroscience Award, and the Marcus Foundation Award. Dr. Sugar has received research grant support from NIH through multiple divisions, including NIMH, the National Institute of General Medical Sciences (NIGMS), NICHD, NIAID, and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), HRSA, the Food and Drug Administration (FDA), and the US Department of Veterans Affairs. She has served on technical expert panels for CMS and Data Safety and Monitoring Boards for both academic institutions and Kaiser Permanente. Ms. Wallace has received grant funding from the US Department of Defense and the Tennessee Department of Education. Ms. Whelan has received grant support from NIMH. Drs. Greenson and Hellemann have reported no biomedical financial interests or potential conflicts of interest. |
Vol 60 - N° 6
P. 710-722 - juin 2021 Retour au numéro
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