- Luc Lecavalier ORCID:orcid.org/0000-0002-1162-659X1,
- Xueliang Pan2,
- Tristram Smith3,
- Benjamin L. Handen4,
- L. Eugene Arnold5,
- Laura Silverman3,
- Rameshwari V. Tumuluru4,
- Jill Hollway5 &
- …
- Michael G. Aman1
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13Citations
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Abstract
We previously reported a 2 × 2 randomized clinical trial of atomoxetine (ATX) and parent training (PT) for attention deficit hyperactivity disorder (ADHD) symptoms and behavioral noncompliance in 128 children with autism spectrum disorder, ages 5–14 years. Children were randomized to one of four conditions: ATX alone, placebo alone, ATX + PT, or PT + placebo. Both ATX and PT improved some indices of ADHD and behavioral compliance. In this report, we describe parent stress over time and across conditions. All four treatments improved parent self-rated stress from baseline to week 10. However, there were no statistically significant differences between treatment groups. Significantly more improvement in parent stress scores was observed for clinical responders than non-responders.
ClinicalTrials.gov Title: Atomoxetine, Placebo and Parent Management Training in Autism (Strattera)ClinicalTrials.gov Identifier: NCT00844753.
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Funding
This work was supported by grants from the National Institute of Mental Health to Ohio State University (5R01MH079080), University of Pittsburgh (5R01MH079082-05), and University of Rochester (5R01 MH083247), by Eli Lilly and Co., who provided atomoxetine and placebo, and by the University of Rochester CTSA (UL1 RR024160) and Ohio State University CTSA (UL1TR001070) from the National Center for Research Resources and the National Center for Advancing Translational Sciences of the National Institutes of Health.
Author Contributions
LL participated in design and coordination of current study, participated in analysis, and drafted the manuscript; XP performed the statistical analyses and assisted in drafting the manuscript; TS conceived the original study, participated in its design and coordination, assisted with data interpretation, helped to draft the manuscript; BLH conceived the original study, participated in its design and coordination, assisted with data interpretation, helped to draft the manuscript; LEA conceived the original study, participated in its design and coordination, assisted with data interpretation, helped to draft the manuscript; LS participated in original study, assisted to draft the manuscript; RVT participated in original study, assisted to draft the manuscript; JH participated in original study, assisted to draft the manuscript; MGA conceived the original study, participated in its design and coordination, assisted with data interpretation and helped to draft the manuscript. All authors read and approved the final manuscript.
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Authors and Affiliations
Nisonger Center and Department of Psychology, Ohio State University, 371D McCampbell Hall, 1581 Dodd Dr., Columbus, OH, 43210, USA
Luc Lecavalier & Michael G. Aman
Center for Biostatistics, Department of Biomedical Informatics, Ohio State University, 371D McCampbell Hall, 1581 Dodd Dr., Columbus, OH, 43210, USA
Xueliang Pan
University of Rochester Medical Center (URMC), 601 Elmwood Ave, Box 671, Rochester, NY, 14642, USA
Tristram Smith & Laura Silverman
Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, 3811 O’Hara St., Pittsburgh, PA, 15213, USA
Benjamin L. Handen & Rameshwari V. Tumuluru
Nisonger Center and Department of Psychiatry, Ohio State University, 285B McCampbell Hall, 1581 Dodd Drive, Columbus, OH, 43210, USA
L. Eugene Arnold & Jill Hollway
- Luc Lecavalier
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Conflict of interest
Dr. Aman has received research contracts, consulted with, served on advisory boards, or done investigator training for AMO Pharma, CogState, Inc.; Confluence Pharmaceutica; CogState Clinical Trials, Ltd.; Coronado Biosciences; Forest Research; Hoffman-La Roche; Johnson & Johnson, Lumos Pharma, MedAvante, Inc.; Novartis; Ovid Therapeutics, ProPhase LLC; and Supernus Pharmaceuticals. Dr. Handen has received research support from Lilly, Roche, Curemark, Autism Speaks, NIMH, and NIA. Dr. Arnold has received research funding from Curemark, Forest, Lilly, Neuropharm, Novartis, Noven, Shire, Supernus, Roche, YoungLiving, NIH and Autism Speaks. He has consulted with Gowlings, Neuropharm, Organon, Pfizer, Sigma Tau, Shire, Tris Pharma, and Waypoint. He has been on advisory boards for Arbor, Ironshore, Novartis, Noven, Otsuka, Pfizer, Roche, Seaside Therapeutics, Sigma Tau, Shire, and received travel support from Noven. Dr. Hollway has received research funding from Forest Research Institute, Sunovion Pharmaceuticals, Supernus Pharmaceuticals, Young Living, F. Hoffman-La Roche AG, and Autism Speaks. Drs. Lecavalier, Pan, Smith, Tumuluru, and Silverman, have no conflicts of interest to report.
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Informed consent was obtained from all individual participants who were included in this article.
Research Involving Human Participants
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committees and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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Lecavalier, L., Pan, X., Smith, T.et al. Parent Stress in a Randomized Clinical Trial of Atomoxetine and Parent Training for Children with Autism Spectrum Disorder.J Autism Dev Disord48, 980–987 (2018). https://doi.org/10.1007/s10803-017-3345-4
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