In the fall of 2006 Scott Kollins, Laurence Greenhilll, James Swanson and a host of colleagues described the Preschool ADHD Treatment Study (PATS; funded by the US National Institute of Mental Heath or NIMH) in one of a series of articles in the prestigious Journal of the American Academy of Child & Adolescent Psychiatry. In other articles, the research team presented the outcomes of the study: Ratings of ADHD symptoms were lower among children who received doses of between 2.5 and 7.5 mgs of Methylphenidate three times a day and children taking the medication grew more slowly than expected.
The PATS project is noteworthy for its rigor and thoroughness. In addition, it is important to note that the children and families who participated in the study had already received strong behavior management training; only children who did not respond to that training were included in this study.
In ADDitude Magazine under the headline “Preschoolers and Attention Deficit Disorder (ADHD): Is it possible to diagnose attention deficit disorder (ADD) in preschoolers? A new study provides insight” Arlene Schusteff discusses this research (link). She has quotes from the researchers as well as additional descriptions of the outcomes. For those who would like to have the actual abstracts of the papers, I’ve provided them here.
Professor Kollins and colleagues described the study in this way:
PATS was a National Institutes of Mental Health-funded, multicenter, randomized, efficacy trial designed to evaluate the short-term (5 weeks) efficacy and long-term (40 weeks) safety of methylphenidate (MPH) in preschoolers with attention-deficit/hyperactivity disorder (ADHD). Three hundred three subjects ages 3 to 5.5 years old who met criteria for a primary DSM-IV diagnosis of ADHD entered the trial. Subjects participated in an 8-phase, 70-week trial that included screening, parent training, baseline, open-label safety lead-in, double-blind crossover titration, double-blind parallel efficacy, open-label maintenance, and double-blind discontinuation. Medication response was assessed during the crossover titration phase using a combination of parent and teacher ratings. Special ethical considerations throughout the trial warranted a number of design changes. Results: This report describes the design of this trial, the rationale for reevaluation and modification of the design, and the methods used to conduct the trial. Conclusions: The PATS adds to a limited literature and improves our understanding of the safety and efficacy of MPH in the treatment of preschoolers with ADHD, but changes in the design and problems in implementation of this study impose some specific limitations that need to be addressed in future studies.
Dr. Greenhill and colleagues described the methods and results of the study.
Objective: The Preschool ADHD Treatment Study (PATS) was a NIMH-funded, six-center, randomized, controlled trial to determine the efficacy and safety of immediate-release methylphenidate (MPH-IR), given t.i.d. to children ages 3 to 5.5 years with attention-deficit/hyperactivity disorder (ADHD). Method: The 8-phase, 70-week PATS protocol included two double-blind, controlled phases, a crossover-titration trial followed by a placebo-controlled parallel trial. The crossover-titration phase’s primary efficacy measure was a combined score from the Swanson, Kotkin, Atkins, M-Flynn, and Pelham (SKAMP) plus the Conners, Loney, and Milich (CLAM) rating scales; the parallel phase’s primary outcome measure was excellent response, based on composite scores on the Swanson, Nolan, and Pelham (SNAP) rating scale. Results: Of 303 preschoolers enrolled, 165 were randomized into the titration trial. Compared with placebo, significant decreases in ADHD symptoms were found on MPH at 2.5 mg (p < .01), 5 mg (p < .001), and 7.5 mg (p < .001) t.i.d. doses, but not for 1.25 mg (p < .06). The mean optimal MPH total daily dose for the entire group was 14.2 ± 8.1 mg/day (0.7 ± 0.4 mg/kg/day). For the preschoolers (n = 114) later randomized into the parallel phase, only 21% on best-dose MPH and 13% on placebo achieved MTA-defined categorical criterion for remission set for school-age children with ADHD. Conclusions: MPH-IR, delivered in 2.5-, 5-, and 7.5-mg doses t.i.d., produced significant reductions on ADHD symptom scales in preschoolers compared to placebo, although effect sizes (0.4-0.8) were smaller than those cited for school-age children on the same medication.
Professor Swanson and colleagues reported about the effects of the pharmacological treatment on children’s growh this their article. Here’s the abstract:
Objective: To investigate growth of children with attention-deficit/hyperactivity disorder (ADHD) in the Preschool ADHD Treatment Study (PATS) before and after initiation of treatment with methylphenidate at titrated doses (average, 14.2 mg/day) administered three times daily, 7 days/week for ≈1 year. Method: The heights and weights of 140 children with ADHD were measured up to 29 times in the PATS protocol, starting at an average age of 4.4 years. The relationship between standard (z) scores and time on medication was examined using mixed-effect regression to estimate change in relative size (slope). Results: Average relative size at baseline was significantly (p < .0001) greater than zero for z height (+0.45) and z weight (+0.78), indicating greater than expected height (by 2.04 cm) and weight (by 1.78 kg). During treatment, slopes were significantly (p < .0001) less than zero for z height (-0.304/yr) and z weight (-0.530/yr), indicating reduction of growth rates. For 95 children who remained on medication, annual growth rates were 20.3% less than expected for height (5.41 cm/yr - 6.79 cm/yr = -1.38 cm/yr) and 55.2% for weight (1.07 kg/yr - 2.39 kg/yr = -1.32 kg/yr). Conclusions: Risks of reduced growth rates should be balanced against expected benefits when preschool-age children are treated with stimulant medication.
References:
Greenhill, L., Kollins, S., Abikoff, H., McCracken, J., Riddle, M., Swanson, J., et al. (2006). Efficacy and safety of immediate-release Methylphenidate treatment for preschoolers With ADHD. Journal of the American Academy of Child & Adolescent Psychiatry, 45, 1284-1293.
Kollins, S., Greenhill, L., Swanson, J., Wigal, S., Abikoff, H., McCracken, J., et al. (2006). Rationale, design, and methods of the Preschool ADHD Treatment Study (PATS). Journal of the American Academy of Child & Adolescent Psychiatry, 45, 1275-1283.
Swanson, J., Greenhill, L., Wigal, T., Kollins, S., Stehli, A., Davies, M., et al. (2006). Stimulant-related reductions of growth rates in the PATS. Journal of the American Academy of Child & Adolescent Psychiatry, 45, 1304-1313.
Also see the US NIMH press release about the project.
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