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Efficacy of Osmotic-Release Oral System (OROS) Methylphenidate for Mothers With Attention-Deficit/Hyperactivity Disorder (ADHD): Preliminary Report of Effects on ADHD Symptoms and Parenting
Andrea Chronis-Tuscano, Ph.D.; Karen E. Seymour, M.A.; Mark A. Stein, Ph.D.; Heather A. Jones, Ph.D.; Cynthia D. Jiles, R.Ph.; Mary E. Rooney, B.A.; Charles J. Conlon, M.D.; Lisa A. Efron, Ph.D.; Stephanie A. Wagner, B.A.; Jessica Pian, B.A.; and Adelaide S. Robb, M.D.
Objective: A preliminary study to examine the efficacy of osmotic-release oral system (OROS) methylphenidate for attention-deficit/hyperactivity disorder (ADHD) symptoms and parenting behaviors in mothers with ADHD who had children with ADHD.
Method: Participants included 23 mother-child dyads in which both were diagnosed with DSM-IV ADHD. Mothers underwent a 5-week, double-blind titration (placebo, 36 mg/day, 54 mg/day, 72 mg/day, 90 mg/day) to an optimal dose of OROS methylphenidate, followed by random assignment to 2 weeks of placebo or their maximally effective dose. Primary outcome measures included maternal ADHD symptoms (Conners' Adult ADHD Rating Scale) and parenting (Alabama Parenting Questionnaire). Secondary outcomes included side effects ratings. Data were collected from December 2004 until August 2006.
Results: During Phase 1, mothers reported significant decreases in inattention (p < .001) and hyperactivity/impulsivity (p < .01) with increases in OROS methylphenidate dose. As dose increased, significant reductions in inconsistent discipline (p < .01) and corporal punishment use (p < .005) were also demonstrated. During Phase 2, small effects on inattention (d = 0.46) and hyperactivity/impulsivity (d = 0.38) were found for those randomly assigned to medication versus placebo. In addition, medium to large medication effects were found on maternal involvement (d = 0.52), poor monitoring/supervision (d = 0.70), and inconsistent discipline (d = 0.71), with small effects on corporal punishment (d = 0.42). During both phases, few adverse effects were noted.
Conclusions: OROS methylphenidate was well tolerated and was associated with significant improvement in maternal ADHD symptoms and parenting. Variable effects on parenting suggest that behavioral interventions may be necessary to address impairments in parenting among adults with ADHD.
Trial Registration: clinicaltrials.gov Identifier: NCT00318981
(J Clin Psychiatry 2008;69:1938-1947. Online Ahead of Print December 2, 2008.)
Received Dec. 6, 2007; accepted April 23, 2008. From the Department of Psychology, University of Maryland, College Park (Drs. Chronis-Tuscano and Jones and Mss. Seymour, Rooney, Wagner, and Pian); George Washington University School of Medicine, Children's National Medical Center, Washington, D.C. (Drs. Chronis-Tuscano, Jiles, Conlon, Efron, and Robb); and the University of Illinois at Chicago, Institute for Juvenile Research (Dr. Stein).
This study was supported by McNeil Pediatrics, Division of McNeil-PPC, Inc., Fort Washington, Pa.
We acknowledge the statistical consultation of Subhash Aryal, M.S., at the University of Illinois at Chicago and Kevin O'Grady, Ph.D., at the University of Maryland, College Park. Mr. Aryal and Dr. O'Grady report no financial affiliations or other relationships relevant to the subject of this article.
Financial disclosure is listed at the end of the article.
Corresponding author and reprints: Andrea Chronis-Tuscano, Ph.D., University of Maryland, Department of Psychology, College Park, MD 20742 (e-mail: email@example.com).