Medication and Parent Training in Children With Pervasive Developmental Disorders and Serious Behavior Problems: Results From a Randomized Clinical Trial

The Nisonger Center UCEDD, Ohio State University, Columbus, OH 43210-1257, USA.
Journal of the American Academy of Child and Adolescent Psychiatry (Impact Factor: 7.26). 10/2009; 48(12):1143-54. DOI: 10.1097/CHI.0b013e3181bfd669
Source: PubMed


Many children with pervasive developmental disorders (PDDs) have serious, functionally impairing behavioral problems. We tested whether combined treatment (COMB) with risperidone and parent training (PT) in behavior management is superior to medication alone (MED) in improving severe behavioral problems in children with PDDs.
This 24-week, three-site, randomized, parallel-groups clinical trial enrolled 124 children, aged 4 through 13 years, with PDDs, accompanied by frequent tantrums, self-injury, and aggression. The children were randomized 3:2 to COMB (n = 75) or MED (n = 49). The participants received risperidone monotherapy from 0.5 to 3.5 mg/day (with switch to aripiprazole if risperidone was ineffective). Parents in the COMB group (n = 75; 60.5%) received a mean of 10.9 PT sessions. The primary measure of compliance was the Home Situations Questionnaire (HSQ) score.
Primary: intent-to-treat random effects regression showed that COMB was superior to MED on HSQ (p = .006) [effect size at week 24 (d) = 0.34]. The HSQ score declined from 4.31 (± 1.67) to 1.23 (± 1.36) for COMB compared with 4.16 (± 1.47) to 1.68 (± 1.36) for MED. Secondary: groups did not differ on Clinical Global Impressions-Improvement scores at endpoint; compared with MED, COMB showed significant reductions on Aberrant Behavior Checklist Irritability (d = 0.48; p = .01), Stereotypic Behavior (d = 0.23; p = .04), and Hyperactivity/Noncompliance subscales (d = 0.55; p = .04). Final risperidone mean dose for MED was 2.26 mg/day (0.071 mg/kg), compared with 1.98 mg/day for COMB (0.066 mg/kg) (p = .04).
Medication plus PT resulted in greater reduction of serious maladaptive behavior than MED in children with PDDs, with a lower risperidone dose.

Download full-text


Available from: James A Mulick
  • Source
    • "Abbreviated Scale of Intelligence (WASI) conducted by an experienced research assistant (Wechsler 1997). Parents fill out demographic , medical history, and treatment history forms that were used in our previous clinical trials (Aman et al. 2009;Sukhodolsky et al. 2009;Piacentini et al. 2010) as well as ratings of disruptive behavior , adaptive functioning, and associated symptoms. The Pubertal Development Scale (PDS)(Petersen et al. 1988) is completed by parent and children to measure pubertal development status. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Objective: We present the rationale and design of a randomized controlled trial of cognitive-behavioral therapy (CBT) for aggression in children and adolescents, which is conducted in response to the National Institute of Mental Health (NIMH) Research Domain Criteria (RDoC) approach initiative. Specifically, the study is focused on the brain-behavior associations within the RDoC construct of frustrative non-reward. On the behavioral level, this construct is defined by reactions elicited in response to withdrawal or prevention of reward, most notably reactive aggression. This study is designed to test the functional magnetic resonance (fMRI) and electrophysiological (EEG) correlates of aggression and its reduction after CBT. Methods: Eighty children and adolescents with high levels of aggression across multiple traditional diagnostic categories, ages 8-16, will be randomly assigned to receive 12 sessions of CBT or 12 sessions of supportive psychotherapy. Clinical outcomes will be measured by the ratings of aggressive behavior collected at baseline, midpoint, and endpoint evaluations, and by the Improvement Score of the Clinical Global Impressions Scale assigned by an independent evaluator (blinded rater). Subjects will also perform a frustration-induction Go-NoGo task and a task of emotional face perception during fMRI scanning and EEG recording at baseline and endpoint. Results: Consistent with the NIMH strategic research priorities, if functional neuroimaging and EEG variables can identify subjects who respond to CBT for aggression, this can provide a neuroscience-based classification scheme that will improve treatment outcomes for children and adolescents with aggressive behavior. Conclusions: Demonstrating that a change in the key nodes of the emotion regulation circuitry is associated with a reduction of reactive aggression will provide evidence to support the validity of the frustrative non-reward construct.
    Full-text · Article · Jan 2016 · Journal of child and adolescent psychopharmacology
  • Source
    • "While many studies have shown the importance of combining medication and psychosocial interventions (mostly parental education) for children with ADHD, there are only a few studies on the combined medication and behavioral approach in ASD children. Aman et al. (2009) primarily targeted frequent tantrums, self-injury, and aggression in a trial of risperidone treatment and parent training, but the combined effects on hyperactivity were also examined. Results indicated that children who received the combined treatments had lower rates of aggression and greater reduction in hyperactivity (requiring lower risperidone dose), as compared with children who received medication only. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Symptoms of attention deficit hyperactivity disorder (ADHD) and autistic spectrum disorder (ASD) often co-occur. The DSM-IV had specified that an ASD diagnosis is an exclusion criterion for ADHD, thereby limiting research of this common clinical co-occurrence. As neurodevelopmental disorders, both ASD and ADHD share some phenotypic similarities, but are characterized by distinct diagnostic criteria. The present review will examine the frequency and implications of this clinical co-occurrence in children, with an emphasis on the available data regarding pre-school age. The review will highlight possible etiologies explaining it, and suggest future research directions necessary to enhance our understanding of both etiology and therapeutic interventions, in light of the new DSM-V criteria, allowing for a dual diagnosis.
    Full-text · Article · Apr 2014 · Frontiers in Human Neuroscience
  • Source
    • "Some of these medications have clear value in the management of interfering symptoms and behaviors associated with ASD. Improvements in social behaviors have been noted in some trials, though these findings often derive from secondary analyses [e.g., studies of risperidone (Scahill et al. 2012)], or are from open-label studies, (Aman et al. 2009) or are from populations with specific comorbidity [e.g., hyperactivity in trials of methylphenidate and guanfacine (Scahill et al. 2006; Jahromi et al. 2009)]. By contrast, few studies have prospectively aimed to demonstrate an impact on the core social and communicative symptoms of ASD. "
    [Show abstract] [Hide abstract]
    ABSTRACT: STX209 (arbaclofen), a selective GABA-B agonist, is hypothesized to modulate the balance of excitatory to inhibitory neurotransmission, and has shown preliminary evidence of benefit in fragile X syndrome. We evaluated its safety, tolerability, and efficacy in non-syndromic autism spectrum disorders, in an 8-week open-label trial enrolling 32 children and adolescents with either Autistic Disorder or Pervasive Developmental Disorder-Not Otherwise Specified, and a score ≥17 on the Aberrant Behavior Checklist (ABC)-Irritability subscale. STX209 was generally well-tolerated. The most common adverse events were agitation and irritability, which typically resolved without dose changes, and were often felt to represent spontaneous variation in underlying symptoms. Improvements were observed on several outcome measures in this exploratory trial, including the ABC-Irritability (the primary endpoint) and the Lethargy/Social Withdrawal subscales, the Social Responsiveness Scale, the CY-BOCS-PDD, and clinical global impression scales. Placebo-controlled study of STX209 is warranted.
    Full-text · Article · Nov 2013 · Journal of Autism and Developmental Disorders
Show more