Parents’ attitudes toward methylphenidate using n-of-1 trial: a pilot study

Abstract

To compare parents' attitudes toward methylphenidate treatment in children with attention deficit hyperactivity disorder employing two approaches: (1) a 2-week double-blind placebo-drug trial (n-of-1 trial), (2) a traditional prescription approach. The study group (N-50) and a comparison group (N-45) were recruited. The Abbreviated Acceptability Rating Profile was administered prior to and following the pediatricians' consultation, and in 2, 4, and 8 weeks after prescription. Complete data set was available for 21 children in each group. While initial attitudes were similar, a significantly more favorable attitude following the performance of an n-of-1 trial and throughout the follow-up in the study group only was noted. Adherence was significantly correlated with attitude score in the study group only. An individual n-of-1 trial with methylphenidate appears to positively affect parents' attitudes toward drug treatment and may also help adherence with this treatment.

The Short-Term Placebo Response in Children With Attention-Deficit Hyperactivity Disorder (ADHD)

“…However, we are not aware of any bias related to the referral of children to our service or a bias related to randomization of ADHD subtypes in the placebo/drug trials. 45,54 Furthermore our results are valid for children with no associated disorders as formally diagnosed using the Diagnostic and Statistical Manual of Mental Disorders criteria. It is plausible that the exclusion of children with associated conduct and oppositional defiant disorders (ODD) has affected the proportion of children with hyperactive impulsive and combined ADHD in the present study.…”

“…This approach was also found to be related to parents’ and children’s attitudes and maintenance on drug. 29,43 –48 Mechanisms proposed to underlie the placebo effect include expectancy effect, conditioning, learning by imitation, and changes in the caregiver perception and action. 21,23 –25 All these mechanisms are potentially responsible for the different response-related variables discussed below: Type of ADHD: The lack of difference in placebo response as related to the type of ADHD, the similar correlation of the response as related to baseline in the 2 subtypes and the significant relationship with clinical symptoms.…”

A scoping review of randomized trials assessing the impact of n-of-1 trials on clinical outcomes

“…Two trials, one of which was quasi-randomized, compared parents’ attitudes towards using methylphenidate in treating children with attention deficit hyperactivity disorder [ 10 , 17 ].…”

“…Only one of the studies showed benefit of n-of-1 trials in the pre-specified primary outcome [ 17 ]. This trial, which was not truly randomized, showed higher acceptability of methylphenidate treatment among parents whose children underwent an n-of-1 trial compared to those who were treated according to usual care.…”

“…In two trials, the allocation process was at high risk for bias. In Taragin 2013, participants were not randomized to treatment groups [ 17 ]. Patients were referred by their pediatrician to one of three consulting clinics, one of which routinely employed n-of-1 trials while the other clinics offered usual care.…”