Methylphenidate Effects on Functional Outcomes in the Preschoolers with Attention-Deficit/Hyperactivity Disorder Treatment Study (PATS)

New York University Child Study Center, 215 Lexington Avenue, New York, NY 10016, USA.
Journal of Child and Adolescent Psychopharmacology (Impact Factor: 2.93). 10/2007; 17(5):581-92. DOI: 10.1089/cap.2007.0068
Source: PubMed


The purpose of this study was to examine the effects of methylphenidate (MPH) on functional outcomes, including children's social skills, classroom behavior, emotional status, and parenting stress, during the 4-week, double-blind placebo controlled phase of the Preschoolers with Attention Deficit/Hyperactivity Disorder (ADHD) Treatment Study (PATS).
A total of 114 preschoolers who had improved with acute MPH treatment, were randomized to their best MPH dose (M = 14.22 mg/day; n = 63) or placebo (PL; n = 51). Assessments included the Clinical Global Impression-Severity (CGI-S), parent and teacher versions of the Strengths and Weaknesses of ADHD-Symptoms and Normal Behaviors (SWAN), Social Competence Scale (SCS), Social Skills Rating System (SSRS), and Early Childhood Inventory (ECI), and Parenting Stress Index (PSI).
Medication effects varied by informant and outcome measure. Parent measures and teacher SWAN scores did not differentially improve with MPH. Parent-rated depression (p < 0.02) and dysthymia (p < 0.001) on the ECI worsened with MPH, but scores were not in the clinical range. Significant medication effects were found on clinician CGI-S (p < 0.0001) and teacher social competence ratings (SCS, p < 0.03).
Preschoolers with ADHD treated with MPH for 4 weeks improve in some aspects of functioning. Additional improvements might require longer treatment, higher doses, and/or intensive behavioral treatment in combination with medication.

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Available from: Kelly Posner, Dec 27, 2013
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    • "Randomized controlled trials support the value of stimulant treatment, although effects on core ADHD symptoms and functional outcomes may be smaller and less consistent than in older children and side effects more frequent (Abikoff et al., 2007; Greenhill et al., 2006). Because of resistance to medicating young children (Volkow & Insel, 2003), the development of effective nonpharmacological treatments for preschoolers represents an important health policy objective. "
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    ABSTRACT: Background The ‘New Forest Parenting Package’ (NFPP), an 8-week home-based intervention for parents of preschoolers with attention-deficit/hyperactivity disorder (ADHD), fosters constructive parenting to target ADHD-related dysfunctions in attention and impulse control. Although NFPP has improved parent and laboratory measures of ADHD in community samples of children with ADHD-like problems, its efficacy in a clinical sample, and relative to an active treatment comparator, is unknown. The aims are to evaluate the short- and long-term efficacy and generalization effects of NFPP compared to an established clinic-based parenting intervention for treating noncompliant behavior [‘Helping the Noncompliant Child’ (HNC)] in young children with ADHD.MethodsA randomized controlled trial with three parallel arms was the design for this study. A total of 164 3-4-year-olds, 73.8% male, meeting DSM-IV ADHD diagnostic criteria were randomized to NFPP (N = 67), HNC (N = 63), or wait-list control (WL, N = 34). All participants were assessed at post-treatment. NFPP and HNC participants were assessed at follow-up in the next school year. Primary outcomes were ADHD ratings by teachers blind to and uninvolved in treatment, and by parents. Secondary ADHD outcomes included clinician assessments, and laboratory measures of on-task behavior and delay of gratification. Other outcomes included parent and teacher ratings of oppositional behavior, and parenting measures. (Trial name: Home-Based Parent Training in ADHD Preschoolers; Registry: Identifier: NCT01320098; URL: http://www/ both treatment groups, children's ADHD and ODD behaviors, as well as aspects of parenting, were rated improved by parents at the end of treatment compared to controls. Most of these gains in the children's behavior and in some parenting practices were sustained at follow-up. However, these parent-reported improvements were not corroborated by teacher ratings or objective observations. NFPP was not significantly better, and on a few outcomes significantly less effective, than HNC.Conclusions The results do not support the claim that NFPP addresses putative dysfunctions underlying ADHD, bringing about generalized change in ADHD, and its underpinning self-regulatory processes. The findings support documented difficulties in achieving generalization across nontargeted settings, and the importance of using blinded measures to provide meaningful assessments of treatment effects.
    Full-text · Article · Oct 2014 · Journal of Child Psychology and Psychiatry
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    • "6 trials: Abikoff (2007) Findling (2006) Wigal (2004) Biederman (2003) Wolraich (2001) Pliszka (2000) Newcorn (2008) Dell'Agnello (2009) Martenyl (2010) Gau (2007) Kelsey (2004) Michelson (2001) Kratochvil (2011) Montoya (2009) Takahashi (2009) Block (2009) Weiss (2005) Michelson (2002) Bangs (2008) Spencer (2002) [study 1 & 2] LDX "
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    ABSTRACT: Objective:Jump to sectionObjective:Research design and methods:Main outcome measures:Results:Conclusions:IntroductionPatients and methodsResultsDiscussionConclusionTransparencySystematically review and synthesize the clinical evidence of treatments for attention deficit hyperactivity disorder (ADHD) by indirectly comparing established treatments in the UK with a drug recently approved in Europe (lisdexamfetamine [LDX]).Research design and methods:Jump to sectionObjective:Research design and methods:Main outcome measures:Results:Conclusions:IntroductionPatients and methodsResultsDiscussionConclusionTransparencyPopulation: children and adolescents. Setting: Europe. Comparators: methylphenidate (MPH), atomoxetine (ATX), and dexamphetamine (DEX). Electronic databases and relevant conference proceedings were searched for randomized, controlled clinical trials evaluating efficacy and safety of at least one of the comparators and LDX. Quality assessments for each included trial were performed using criteria recommended by the Centre for Reviews and Dissemination. Network meta-analysis methods for dichotomous outcomes were employed to evaluate treatment efficacy.Main outcome measures:Jump to sectionObjective:Research design and methods:Main outcome measures:Results:Conclusions:IntroductionPatients and methodsResultsDiscussionConclusionTransparencyResponse, as defined by either a reduction from baseline of at least 25% in the ADHD Rating Scale [ADHD-RS] total score or, separately, as assessed on the Clinical Global Impression–Improvement [CGI-I] scale, and safety (all-cause withdrawals and withdrawal due to adverse events).Results:Jump to sectionObjective:Research design and methods:Main outcome measures:Results:Conclusions:IntroductionPatients and methodsResultsDiscussionConclusionTransparencyThe systematic review found 32 trials for the meta-analysis, including data on LDX, ATX, and different formulations of MPH. No trials for DEX meeting the inclusion criteria were found. Sufficient data were identified for each outcome: ADHD-RS, 16 trials; CGI-I, 20 trials; all-cause withdrawals, 28 trials; and withdrawals due to adverse events, 27 trials. The relative probability of treatment response for CGI-I (95% confidence intervals [CI]) for ATX versus LDX was 0.65 (0.53–0.78); for long-acting MPH versus LDX, 0.82 (0.69–0.97); for intermediate release MPH versus LDX, 0.51 (0.40–0.65); and for short-acting MPH versus LDX, 0.62 (0.51–0.76). The relative probabilities of ADHD-RS treatment response also favored LDX.Conclusions:Jump to sectionObjective:Research design and methods:Main outcome measures:Results:Conclusions:IntroductionPatients and methodsResultsDiscussionConclusion TransparencyFor the treatment of ADHD, the synthesis of efficacy data showed statistically significant better probabilities of response with LDX than for formulations of MPH or ATX. The analysis of safety data proved inconclusive due to low event rates. These results may be limited by the studies included, which only investigated the short-term efficacy of medications in patients without comorbid disorders.
    Full-text · Article · Mar 2014 · Current Medical Research and Opinion
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    • "In particular, psychological side effect such as mood changes, irritability, depression and subdued personality are frequent reasons for discontinuation [43]. Increased moodiness and irritability appears to be more common among preschool children than older ones [49]. Other reasons for changing or discontinuing medications are slowing of the child’s growth, development of tics, rashes and other concerns the young person or family attribute to the medication. "
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    ABSTRACT: Safe and effective medication for attention deficit hyperactivity disorder (ADHD) is available and recommended as first-line treatment for the core symptoms of inattention, overactivity and impulsiveness. Despite impaired functioning during adolescence, many discontinue medication treatment. For children, healthcare decisions are usually made by the parent; older youth make their own decisions. Beliefs and attitudes may differ widely. Some families understand that ADHD is a neurobiological condition and accept that medication is indicated, for others, such treatment is unacceptable. Converging evidence describes negative perceptions of the burden associated with medication use as well as concerns about potential short and long term adverse effects. Indeed experiences of adverse effects are a frequent explanation for discontinuation among youth. Ways to improve shared decision making among practitioners, parents and youth, and to monitor effectiveness, safety and new onset of concurrent difficulties are likely to optimize outcomes.
    Preview · Article · Jul 2013 · Current Psychiatry Reports
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