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Randomized Controlled Trial
. 2016 Oct;55(10):868-876.e2.
doi: 10.1016/j.jaac.2016.06.015. Epub 2016 Aug 2.

Atomoxetine and Parent Training for Children With Autism and Attention-Deficit/Hyperactivity Disorder: A 24-Week Extension Study

Tristram Smith  1 , Michael G Aman  2 , L Eugene Arnold  2 , Laura B Silverman  3 , Luc Lecavalier  2 , Jill Hollway  2 , Rameshwari Tumuluru  4 , Susan L Hyman  3 , Kristin A Buchan-Page  5 , Jessica Hellings  2 , Robert R Rice Jr  5 , Nicole V Brown  5 , Xueliang Pan  5 , Benjamin L Handen  4
Affiliations
Randomized Controlled Trial

Atomoxetine and Parent Training for Children With Autism and Attention-Deficit/Hyperactivity Disorder: A 24-Week Extension Study

Tristram Smith et al. J Am Acad Child Adolesc Psychiatry. 2016 Oct.

Abstract

Objective: The authors previously reported on a 2-by-2 randomized clinical trial of individual and combined treatment with atomoxetine (ATX) and parent training (PT) for attention-deficit/hyperactivity disorder (ADHD) symptoms and behavioral noncompliance in 128 5- to 14-year-old children with autism spectrum disorder. In the present report, they describe a 24-week extension of treatment responders and nonresponders.

Method: One-hundred seventeen participants from the acute trial (91%) entered the extension; 84 of these were in 2 subgroups: "treatment responders" (n = 43) from all 4 groups in the acute trial, seen monthly for 24 weeks, and "placebo nonresponders" (n = 41), treated with open-label ATX for 10 weeks. Participants originally assigned to PT continued PT during the extension; the remainder served as controls. Primary outcome measurements were the parent-rated Swanson, Nolan and Pelham ADHD scale and the Home Situations Questionnaire.

Results: Sixty percent (26 of 43) of treatment responders in the acute trial, including 68% of responders originally assigned to ATX, still met the response criteria at the end of the extension. The response rate of placebo nonresponders treated with 10-week open-label ATX was 37% (15 of 41), similar to the acute trial. Children receiving open-label ATX + PT were significantly more likely to be ADHD responders (53% versus 23%) and noncompliance responders (58% versus 14%) than those receiving open-label ATX alone.

Conclusion: Most ATX responders maintained their responses during the extension. PT combined with ATX in the open-label trial appeared to improve ADHD and noncompliance outcomes more than ATX alone. Clinical trial registration information-Atomoxetine, Placebo and Parent Management Training in Autism (Strattera); http://clinicaltrials.gov; NCT00844753.

Keywords: atomoxetine; attention-deficit/hyperactivity disorder; autism; combined modality therapy; outcome assessment.

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Figures

Figure 1
Figure 1
Flow of participants through the study. Note: ATX = atomoxetine; RCT = randomized clinical trial.
See this image and copyright information in PMC

References

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