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Use of a Direct Observational Measure in a Trial of Risperidone and Parent Training in Children with Pervasive Developmental Disorders

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Abstract

A Structured Observational Analog Procedure (SOAP), an analogue measure of parent-child interactions, was used to assess treatment outcome in children with Autism Spectrum Disorder and serious behavior problems. It served as a secondary outcome measure in a 24-week, randomized trial of risperidone (MED; N = 49) versus risperidone plus parent training (COMB; n = 75) (ages 4–13 years). At 24-weeks, there was 28 % reduction in child inappropriate behavior during a Demand Condition (p = .0002) and 12 % increase in compliance to parental requests (p = .004) for the two treatment conditions combined. Parents displayed 64 % greater use of positive reinforcement (p = .001) and fewer repeated requests for compliance (p < .0001). In the analysis of covariance (ANCOVA), COMB parents used significantly more positive reinforcement (p = .01) and fewer restrictive statements (p < .05) than MED parents. The SOAP is sensitive to change in child and parent behavior as a function of risperidone alone and in combination with PMT and can serve as a valuable complement to parent and clinician-based measures.

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Acknowledgements

We wish to acknowledge Catherine A. Belasco, for her valuable assistance in the coding of direct observation data and preliminary data analysis. We also thank all the families who participated in this study.

The views expressed in this article are those of the authors and do not necessarily reflect the official position of the National Institute of Mental Health, the National Institutes of Health, or any other part of the U.S. Department of Health and Human Services. NIMH encourages publication of results and free scientific access to data.

Disclosures

Dr. Handen has received research support from Eli Lilly, Curemark and Bristol-Myers Squibb; Dr. Scahill has served as a consultant or has received research support from Boehringer-Ingelheim, NeuroSearch, Pfizer, Hoffman, BioMarin, Shire and Seaside Therapeutics. Dr. Aman has served as a consultant or received research support from Biomarin Pharmaceuticals, Confluence Pharmaceutica, Forest Research, Hoffman LaRoche, ProPhase and Supernus Pharmaceutica. Dr. Arnold has received research funding or advisory board honoraria from AstraZeneca, Biomarin, Curemark, Eli Lilly, Novartis, Noven, Seaside Therapeutics and Shire and travel support from Noven. Dr. Stigler has received research support from Bristo-Myers Squibb, Curemark, Eli Lilly, Forest Research Institute, Janssen, Novartis and Seaside Therapeutics.

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Authors and Affiliations

  1. University of Pittsburgh School of Medicine, Pittsburgh, PA, USA

    Benjamin L. Handen & Cynthia R. Johnson

  2. Ohio State University, Columbus, OH, USA

    Eric M. Butter, Luc Lecavalier, Michael G. Aman, L. Eugene Arnold, James A. Mulick & Jill A. Hollway

  3. Emory University School of Medicine, Atlanta, GA, USA

    Lawrence Scahill, Karen Bearss & James Dziura

  4. Harvard Medical School, Boston, MA, USA

    Christopher J. McDougle

  5. Indiana University School of Medicine, Indiana, IN, USA

    Naomi B. Swiezy & Kimberly A. Stigler

  6. Yale University, New Haven, CT, USA

    Denis G. Sukhodolsky

  7. Virginia Polytechnic Institute and State University, Blacksburg, VA, USA

    Susan W. White

  8. University of Michigan Medical School, Ann Arbor, MI, USA

    Sunkyung Yu

  9. Children’s Hospital of Pittsburgh, Pittsburgh, PA, USA

    Kelley Sacco

  10. National Institute of Mental Health, Bethesda, MD, USA

    Benedetto Vitiello

  11. Merck Program, Western Psychiatry Institute and Clinic, 1011 Bingham St., Pittsburgh, PA, 15203, USA

    Benjamin L. Handen

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  1. Benjamin L. Handen
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  17. Sunkyung Yu
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  18. Kelley Sacco
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  19. Benedetto Vitiello
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Corresponding author

Correspondence to Benjamin L. Handen.

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Acknowledgement of funding

Supported by the following cooperative agreement grants from the National Institute of Mental Health (NIMH): U10MH66768 (P.I.: M. Aman), U10MH66766 (P.I.: C. McDougle), and U10MH66764 (P.I.: L. Scahill).

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NCT00080145

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Handen, B.L., Johnson, C.R., Butter, E.M. et al. Use of a Direct Observational Measure in a Trial of Risperidone and Parent Training in Children with Pervasive Developmental Disorders. J Dev Phys Disabil 25, 355–371 (2013). https://doi.org/10.1007/s10882-012-9316-y

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