OBJECTIVE: Impairments associated with attention-deficit/hyperactivity disorder (ADHD) and noncompliance are prevalent in children with autism spectrum disorder (ASD). However, ADHD response to stimulants is well below rates in typically developing children, with frequent side effects. Group studies of treatments for noncompliance are rare in ASD. We examined individual and combined-effectiveness of atomoxetine (ATX) and parent training (PT) for ADHD symptoms and noncompliance. METHOD: In a 3-site, 10-week, double-blind, 2 × 2 trial of ATX and PT, 128 children (ages 5-14 years) with ASD and ADHD symptoms were randomized to ATX, ATX+PT, placebo+PT, or placebo. ATX was adjusted to optimal dose (capped at 1.8 mg/kg/day) over 6 weeks and maintained for 4 additional weeks. Nine PT sessions were provided. Primary outcome measures were the parent-rated DSM ADHD symptoms on the Swanson, Nolan and Pelham (SNAP) scale and Home Situations Questionnaire (HSQ). RESULTS: On the SNAP, ATX, ATX+PT and placebo+PT were each superior to placebo (effect sizes 0.57-0.98; p values of .0005, .0004, and .025, respectively). For noncompliance, ATX and ATX+PT were superior to placebo (effect sizes 0.47-0.64; p values .03 and .0028, respectively). ATX was associated with decreased appetite but was otherwise well tolerated. CONCLUSION: Both ATX and PT resulted in significant improvement on ADHD symptoms, whereas ATX (both alone and combined with PT) was associated with significant decreases on measures of noncompliance. ATX appears to have a better side effects profile than psychostimulants in the population with ASD. CLINICAL TRIAL REGISTRATION INFORMATION: Atomoxetine, Placebo and Parent Management Training in Autism; http://clinicaltrials.gov/; NCT00844753.
RCT Entities:
OBJECTIVE: Impairments associated with attention-deficit/hyperactivity disorder (ADHD) and noncompliance are prevalent in children with autism spectrum disorder (ASD). However, ADHD response to stimulants is well below rates in typically developing children, with frequent side effects. Group studies of treatments for noncompliance are rare in ASD. We examined individual and combined-effectiveness of atomoxetine (ATX) and parent training (PT) for ADHD symptoms and noncompliance. METHOD: In a 3-site, 10-week, double-blind, 2 × 2 trial of ATX and PT, 128 children (ages 5-14 years) with ASD and ADHD symptoms were randomized to ATX, ATX+PT, placebo+PT, or placebo. ATX was adjusted to optimal dose (capped at 1.8 mg/kg/day) over 6 weeks and maintained for 4 additional weeks. Nine PT sessions were provided. Primary outcome measures were the parent-rated DSM ADHD symptoms on the Swanson, Nolan and Pelham (SNAP) scale and Home Situations Questionnaire (HSQ). RESULTS: On the SNAP, ATX, ATX+PT and placebo+PT were each superior to placebo (effect sizes 0.57-0.98; p values of .0005, .0004, and .025, respectively). For noncompliance, ATX and ATX+PT were superior to placebo (effect sizes 0.47-0.64; p values .03 and .0028, respectively). ATX was associated with decreased appetite but was otherwise well tolerated. CONCLUSION: Both ATX and PT resulted in significant improvement on ADHD symptoms, whereas ATX (both alone and combined with PT) was associated with significant decreases on measures of noncompliance. ATX appears to have a better side effects profile than psychostimulants in the population with ASD. CLINICAL TRIAL REGISTRATION INFORMATION: Atomoxetine, Placebo and Parent Management Training in Autism; http://clinicaltrials.gov/; NCT00844753.
Authors: David J Posey; Michael G Aman; James T McCracken; Lawrence Scahill; Elaine Tierney; L Eugene Arnold; Benedetto Vitiello; Shirley Z Chuang; Mark Davies; Yaser Ramadan; Andrea N Witwer; Naomi B Swiezy; Pegeen Cronin; Bhavik Shah; Deirdre H Carroll; Christopher Young; Courtney Wheeler; Christopher J McDougle Journal: Biol Psychiatry Date: 2007-02-15 Impact factor: 13.382
Authors: Ovsanna T Leyfer; Susan E Folstein; Susan Bacalman; Naomi O Davis; Elena Dinh; Jubel Morgan; Helen Tager-Flusberg; Janet E Lainhart Journal: J Autism Dev Disord Date: 2006-10
Authors: Michael G Aman; Tristram Smith; L Eugene Arnold; Patricia Corbett-Dick; Rameshwari Tumuluru; Jill A Hollway; Susan L Hyman; Marissa Mendoza-Burcham; Xueliang Pan; Daniel W Mruzek; Luc Lecavalier; Lynne Levato; Laura B Silverman; Benjamin Handen Journal: Res Dev Disabil Date: 2014-04-16
Authors: Laura Silverman; Jill A Hollway; Tristram Smith; Michael G Aman; L Eugene Arnold; Xueliang Pan; Xiaobai Li; Benjamin L Handen Journal: Res Autism Spectr Disord Date: 2014-07-01
Authors: Luc Lecavalier; Courtney E McCracken; Michael G Aman; Christopher J McDougle; James T McCracken; Elaine Tierney; Tristram Smith; Cynthia Johnson; Bryan King; Benjamin Handen; Naomi B Swiezy; L Eugene Arnold; Karen Bearss; Benedetto Vitiello; Lawrence Scahill Journal: Compr Psychiatry Date: 2018-11-06 Impact factor: 3.735
Authors: Rameshwari V Tumuluru; Patricia Corbett-Dick; Michael G Aman; Tristram Smith; L Eugene Arnold; Xueliang Pan; Kristin A Buchan-Page; Nicole V Brown; Melissa M Ryan; Susan L Hyman; Jessica Hellings; Craig Williams; Jill A Hollway; Luc Lecavalier; Robert R Rice; Sarah McAuliffe-Bellin; Benjamin L Handen Journal: J Child Adolesc Psychopharmacol Date: 2017-05-16 Impact factor: 2.576
Authors: Tristram Smith; Michael G Aman; L Eugene Arnold; Laura B Silverman; Luc Lecavalier; Jill Hollway; Rameshwari Tumuluru; Susan L Hyman; Kristin A Buchan-Page; Jessica Hellings; Robert R Rice; Nicole V Brown; Xueliang Pan; Benjamin L Handen Journal: J Am Acad Child Adolesc Psychiatry Date: 2016-08-02 Impact factor: 8.829
Authors: Lawrence Scahill; Karen Bearss; Rena Sarhangian; Christopher J McDougle; L Eugene Arnold; Michael G Aman; James T McCracken; Elaine Tierney; Scott Gillespie; Valentina Postorino; Benedetto Vitiello Journal: J Child Adolesc Psychopharmacol Date: 2016-11-28 Impact factor: 2.576
Authors: Susan Young; Jack Hollingdale; Michael Absoud; Patrick Bolton; Polly Branney; William Colley; Emily Craze; Mayuri Dave; Quinton Deeley; Emad Farrag; Gisli Gudjonsson; Peter Hill; Ho-Lan Liang; Clodagh Murphy; Peri Mackintosh; Marianna Murin; Fintan O'Regan; Dennis Ougrin; Patricia Rios; Nancy Stover; Eric Taylor; Emma Woodhouse Journal: BMC Med Date: 2020-05-25 Impact factor: 8.775
Authors: Laura C Politte; Lawrence Scahill; Janet Figueroa; James T McCracken; Bryan King; Christopher J McDougle Journal: Neuropsychopharmacology Date: 2018-02-27 Impact factor: 7.853
Authors: Jill A Hollway; Marrisa Mendoza-Burcham; Rebecca Andridge; Michael G Aman; Benjamin Handen; L Eugene Arnold; Luc Lecavalier; Craig Williams; Laura Silverman; Tristram Smith Journal: J Child Adolesc Psychopharmacol Date: 2017-11-07 Impact factor: 2.576