Efficacy and Safety of Immediate-Release Methylphenidate Treatment for Preschoolers With ADHD

Columbia University, New York, New York, United States
Journal of the American Academy of Child & Adolescent Psychiatry (Impact Factor: 7.26). 11/2006; 45(11):1284-93. DOI: 10.1097/01.chi.0000235077.32661.61
Source: PubMed


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).
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.
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.
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.

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    • "Compared to both control groups, NFPP yielded clinically significant reductions in parent-reported ADHD symptoms and conduct problems (oppositional, defiant behaviors), increases in observed on-task behavior, and improved maternal sense of well-being. The improvements in ADHD symptoms were in the range found with stimulants in preschoolers (Greenhill et al., 2006) and persisted to 15 weeks follow-up. A second controlled study found no evidence of efficacy when NFPP was delivered by nonspecialist primary care nurses (Sonuga-Barke, Thompson, Daley, & Laver-Bradbury, 2004). "
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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.
    Journal of Child Psychology and Psychiatry 10/2014; 56(6). DOI:10.1111/jcpp.12346 · 6.46 Impact Factor
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    • "While stimulant medication is relatively easy to implement and often provides rapid therapeutic benefit, a significant minority of youth with ADHD do not respond to stimulant medication (10–30 %; Goldman et al. 1998) or experience significant side effects that prohibit continued use (\10 %; Graham and Coghill 2008). Additionally, stimulant medications appear less effective for young children with ADHD (Greenhill et al. 2006) and may result in an increased rate of side effects (Wigal et al. 2006). Parental perceptions of stimulant medication's impact on overall health and preference for alternative (non-medication) treatments also limit the use of and compliance with stimulant medication (Chacko et al. 2010)—by some accounts, up to 58 % of parents refuse stimulant medication for their child with ADHD (Krain et al. 2005). "
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    ABSTRACT: Attention-deficit/hyperactivity disorder (ADHD) is a prevalent and chronic mental health condition that often results in substantial impairments throughout life. Although evidence-based pharmacological and psychosocial treatments exist for ADHD, effects of these treatments are acute, do not typically generalize into non-treated settings, rarely sustain over time, and insufficiently affect key areas of functional impairment (i.e., family, social, and academic functioning) and executive functioning. The limitations of current evidence-based treatments may be due to the inability of these treatments to address underlying neurocognitive deficits that are related to the symptoms of ADHD and associated areas of functional impairment. Although efforts have been made to directly target the underlying neurocognitive deficits of ADHD, extant neurocognitive interventions have shown limited efficacy, possibly due to misspecification of training targets and inadequate potency. We argue herein that despite these limitations, next-generation neurocognitive training programs that more precisely and potently target neurocognitive deficits may lead to optimal outcomes when used in combination with specific skill-based psychosocial treatments for ADHD. We discuss the rationale for such a combined treatment approach, prominent examples of this combined treatment approach for other mental health disorders, and potential combined treatment approaches for pediatric ADHD. Finally, we conclude with directions for future research necessary to develop a combined neurocognitive + skill-based treatment for youth with ADHD.
    Clinical Child and Family Psychology Review 08/2014; 17(4). DOI:10.1007/s10567-014-0171-5 · 4.75 Impact Factor
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    • "Medication and psycho-social interventions are available [16, 17] although where children do not have ADHD, medication is rarely used and treatment approaches rely more on psychological approaches [18]. Behavioural-psychosocial treatments, on their own, are regarded as the most appropriate front-line treatment with younger children even when ADHD is present; except in exceptional circumstances [19]. Non-pharmacological treatments include behaviour therapy, parent training (PT), and cognitive therapy [3]. "
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    ABSTRACT: Disruptive behaviour problems (DBPs) during childhood exert a high burden on individuals, families and the community as a whole. Reducing this impact is a major public health priority. Early parenting interventions are recommended as valuable ways to target DBPs; however, low take-up of, and high drop-out rates from, these programmes seriously reduce their effectiveness. We present a review of published qualitative evidence relating to factors that block or facilitate access and engagement of parents with such programmes using a thematic synthesis approach. 12 papers presenting views of both parents and professionals met our inclusion and quality criteria. A large number of barriers were identified highlighting the array of challenges parents can face when considering accessing and engaging with treatment for their child with behavioural problems. Facilitating factors in this area were also identified. A series of recommendations were made with regard to raising awareness of programmes and recruiting parents, providing flexible and individually tailored support, delivering programmes through highly skilled, trained and knowledgeable therapists, and highlighting factors to consider when delivering group-based programmes. Clinical guidelines should address barriers and facilitators of engagement as well as basic efficacy of treatment approaches. Electronic supplementary material The online version of this article (doi:10.1007/s00787-013-0401-2) contains supplementary material, which is available to authorized users.
    European Child & Adolescent Psychiatry 04/2013; 22(11). DOI:10.1007/s00787-013-0401-2 · 3.34 Impact Factor
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