TY - JOUR
T1 - Does pharmacological treatment of ADHD in adults enhance parenting performance? Results of a double-blind randomized trial
AU - Waxmonsky, James G.
AU - Waschbusch, D. A.
AU - Babinski, D. E.
AU - Humphrey, H. H.
AU - Alfonso, A.
AU - Crum, K. I.
AU - Bernstein, M.
AU - Slavec, J.
AU - Augustus, J. N.
AU - Pelham, W. E.
N1 - Funding Information:
Acknowledgments This study was fully funded by an investigator-initiated grant to Drs. Waxmonsky and Waschbusch from Shire, Inc., the makers of lisdexamfetamine. J. Waxmonsky and D. Waschbusch were the principal investigators. All authors contributed to the discussion and interpretation of results. In the past 3 years, Dr. Wax-monsky has received research funding from Shire (this study), Noven Pharmaceuticals, and Janssen (drug donation) as well as NIMH and served on the advisory board for Noven and as a speaker for CME talks by Quintiles. Dr. Waschbusch has received research support from Shire Inc. (this study) while Dr. Pelham has served on the advisory board for Noven Pharmaceuticals. Both have also received funding from NIMH. Miss Babinski, Dr. Humphrey, Miss Alfonso, Miss Crum, Miss Bernstein, Miss Slavec, and Miss Augustus have no disclosures to report.
Copyright:
Copyright 2014 Elsevier B.V., All rights reserved.
PY - 2014/7
Y1 - 2014/7
N2 - Objective: This study examines the effects of parental lisdexamfetamine (LDX) treatment on parent-child interactions. Methods: Participants were 30 parents (27 % were male) and their children aged 5-12 years, both diagnosed with DSM-IV attention-deficit/hyperactivity disorder (ADHD). Optimal LDX dose (30, 50, or 70 mg/day) was determined for parents during a 3-week open-label titration, followed by a within-subjects trial of the acute impact of LDX and placebo on observable parent-child interactions. Two laboratory-based, parent-child interactions simulating typical family tasks (e.g., homework, joint play) were conducted within 2 weeks, once with the adult on a blinded optimal dose of LDX and once on placebo (phase I). Parents were then randomly assigned to continue blinded treatment with LDX or placebo for another month followed by a third interaction task (phase II) to assess the ongoing effects of LDX on parent-child interactions. The primary outcome was the change in rate of parenting behaviors coded during the parent-child interaction tasks. Secondary outcomes included observed rates of children's inappropriate behaviors during the laboratory tasks and changes in parental ADHD symptom severity (ADHD-Rating Scale). Results: Twenty parents (67 %) completed the trial. In phase I, medication was associated with a significant reduction in negative talk by parents (p = 0.0066, d = -0.47). There was a Medication × Task interaction (p = 0.0235) with a reduction in children's negative behaviors in the homework phase only (p = 0.0154, d = -0.58). In phase II, LDX was associated with significant increases in praise by parents (d = 0.81) and reductions in parental commands (d = -0.88) and children's inappropriate behaviors (d = -0.84) (all p-values < 0.05). While not reaching statistical significance, LDX was also associated with large reductions in parental verbalizations (d = -0.82), moderate increases in parental responsiveness (d = 0.55), and large reductions in the ratio of commands to verbalizations during the non-homework task (d = -1.05) (all p-values < 0.10). Significant reductions in parental ADHD symptoms vs. placebo were observed (p < 0.005). Loss of appetite, dry mouth, headaches, and delayed sleep onset were the most common adverse events. Conclusions: Improvements in parent-child interactions emerged over time with LDX treatment of parental ADHD. Results suggest that pharmacological treatment of parental ADHD may improve outcomes in parents and their children.
AB - Objective: This study examines the effects of parental lisdexamfetamine (LDX) treatment on parent-child interactions. Methods: Participants were 30 parents (27 % were male) and their children aged 5-12 years, both diagnosed with DSM-IV attention-deficit/hyperactivity disorder (ADHD). Optimal LDX dose (30, 50, or 70 mg/day) was determined for parents during a 3-week open-label titration, followed by a within-subjects trial of the acute impact of LDX and placebo on observable parent-child interactions. Two laboratory-based, parent-child interactions simulating typical family tasks (e.g., homework, joint play) were conducted within 2 weeks, once with the adult on a blinded optimal dose of LDX and once on placebo (phase I). Parents were then randomly assigned to continue blinded treatment with LDX or placebo for another month followed by a third interaction task (phase II) to assess the ongoing effects of LDX on parent-child interactions. The primary outcome was the change in rate of parenting behaviors coded during the parent-child interaction tasks. Secondary outcomes included observed rates of children's inappropriate behaviors during the laboratory tasks and changes in parental ADHD symptom severity (ADHD-Rating Scale). Results: Twenty parents (67 %) completed the trial. In phase I, medication was associated with a significant reduction in negative talk by parents (p = 0.0066, d = -0.47). There was a Medication × Task interaction (p = 0.0235) with a reduction in children's negative behaviors in the homework phase only (p = 0.0154, d = -0.58). In phase II, LDX was associated with significant increases in praise by parents (d = 0.81) and reductions in parental commands (d = -0.88) and children's inappropriate behaviors (d = -0.84) (all p-values < 0.05). While not reaching statistical significance, LDX was also associated with large reductions in parental verbalizations (d = -0.82), moderate increases in parental responsiveness (d = 0.55), and large reductions in the ratio of commands to verbalizations during the non-homework task (d = -1.05) (all p-values < 0.10). Significant reductions in parental ADHD symptoms vs. placebo were observed (p < 0.005). Loss of appetite, dry mouth, headaches, and delayed sleep onset were the most common adverse events. Conclusions: Improvements in parent-child interactions emerged over time with LDX treatment of parental ADHD. Results suggest that pharmacological treatment of parental ADHD may improve outcomes in parents and their children.
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U2 - 10.1007/s40263-014-0165-3
DO - 10.1007/s40263-014-0165-3
M3 - Article
C2 - 24796970
AN - SCOPUS:84904750870
SN - 1172-7047
VL - 28
SP - 665
EP - 677
JO - CNS Drugs
JF - CNS Drugs
IS - 7
ER -