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Rationale, design, and methods of the Preschool ADHD Treatment Study (PATS)
Scott Kollins1, Laurence Greenhill2, James Swanson2
1Dr. Kollins is with Duke University Medical Center, Durham, NC; Drs. Greenhill and Posner, Ms. Skrobala, and Mr. Davies are with New York State Psychiatric Institute/Columbia University, New York; Drs. Swanson, S. Wigal, and T. Wigal are with the University of California, Irvine; Dr. Abikoff is with the New York University Child Study Center, New York; Drs. McCracken and McGough are with the University of California, Los Angeles; Dr. Riddle is with Johns Hopkins University, Baltimore; Dr. Vitiello is with the National Institute of Mental Health, Bethesda, MD; Dr. Ghuman is with the University of Arizona, Tucson; Dr. Cunningham is with McMaster University, Hamilton, Ontario, Canada; and Ms. Bauzo is with the Nathan Kline Institute, Orangeburg, NY..
Insights
The Preschool ADHD Treatment Study (PATS) evaluated methylphenidate (MPH) efficacy and safety in young children with attention-deficit/hyperactivity disorder (ADHD). Findings inform MPH use in preschoolers, though study limitations require careful consideration.
Area of Science:
- Pediatric Psychiatry
- Clinical Trial Design
- Pharmacological Interventions
Background:
- The Preschool ADHD Treatment Study (PATS) was a National Institutes of Mental Health-funded trial.
- It aimed to assess short-term efficacy and long-term safety of methylphenidate (MPH) in preschoolers with attention-deficit/hyperactivity disorder (ADHD).
Discussion:
- The study involved 303 children aged 3 to 5.5 years meeting DSM-IV ADHD criteria.
- A complex 70-week, 8-phase protocol included screening, parent training, and blinded medication phases.
- Ethical considerations necessitated design modifications throughout the trial.
Key Insights:
- Medication response was evaluated using parent and teacher ratings during a crossover titration phase.
- The trial design focused on both efficacy and safety of MPH in a young population.
- PATS contributes valuable data to the limited literature on treating ADHD in preschoolers.
Outlook:
- The study highlights the need for further research into MPH treatment for preschool ADHD.
- Design modifications and implementation challenges present limitations for future studies.
- Understanding safety and efficacy in this age group remains a critical area for investigation.
Objective:
To describe the rationale and design of the Preschool ADHD Treatment Study (PATS).
Method:
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.
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