Nisonger Child Behavior Rating Form Research Articles

Testosterone in relation to behavioral problems in pre-pubertal boys with autism spectrum disorders.

Autism spectrum disorders (ASD) are neurodevelopmental conditions characterized by impairment in social communication and presence of stereotyped/restricted behaviors. Children with ASD very often demonstrate co-morbid psychiatric problems, problems known to be affected by testosterone in neurotypical populations. However, there are few reports investigating relationships between testosterone and psychiatric conditions in children with ASD. The aim of this study was to determine the relationship between plasmatic levels of testosterone and behavioral/emotional problems in pre-pubertal boys with ASD. The study sample consisted of 31 pre-pubertal boys (ages 3-10) with ASD. Parents completed the Nisonger Child Behavior Rating Form (NCBRF) to assess specific behavioral/emotional problems as observed in the previous 2 months. Plasmatic testosterone levels were determined in boys according to standardized procedures. It was found that there were positive correlations between testosterone levels and the conduct problems subscale (p=0.034, rs=0.382) of NCBRF and also between testosterone levels and the hyperactive subscale (p=0.025, rs=0.402) of NCBRF. Findings in this study are in line with research conducted in the neurotypical population. This is the first large study investigating testosterone and emotional/behavioral problems in ASD and warrants further research in this field in order to clarify the etiopathogenesis of psychiatric co-morbidities and improve their treatment.

Problem Behavior and Testosterone in Pre-pubertal Boys with Autism Spectrum Disorder

Aim The aim of this study was to compare testosterone level with clinical features of problem behavior in children with ASD. Methods The study sample consisted of 35 pre-pubertal boys with clinical diagnosis of ASD. In all children (ages 3-10) diagnosed as ASD, parents completed Nisonger Child Behavior Rating Form (NCBRF) (version for intellectual disabilities)-parent version. Rating scale assessed child´s behavior as observed in previous 1-2 months. Specific problem behavior was rated on subscales for conduct problems, anxiety, hyperactivity, self-injury/stereotypic behavior, self-isolated/ritualistic and overly sensitive. On this rating form parents also assessed social behavior: compliant behavior and adaptive social behavior. Total serum testosterone levels were determined after the parents completed rating forms, according to standardized procedure. Results It was found positive correlation between total serum testosterone levels and conduct problem subscale (p=0.007, r=0.445) and as well as total serum testosterone levels and overly sensitive subscale (p=0.03, r=0.348) of NCBRF. In other subscalesof NCBRF(problem behavior or social behavior) were no significant correlations. Conclusions The results suggest that there might be some relationship between problem behavior (specifically conduct problems and overal sensitivity) and testosterone levels in boys with ASD. Testosterone levels had no significant correlation with other subscales of NCBRF. However further research is needed for investigation of complex androgen activity (free TST levels, SHBD levels) and potential roles of other hormones in complex etiology of conduct problems and overall sensitivity in children with ASD. This findings rise interest in further investigation of relationship between testosterone and conduct problems and overall sensitivity in children with ASD and indicate that therapeutic strategies targeting testosteronecould be useful in the treatment of problem behaviors in children with ASD. This study was part of broader projects focused on ASD conducted in Autism Research Center for Autism (ARCA), Comenius University and was supported by grants APVV 02544-11 and VEGA1/0086/14.

A comparison of risperidone and buspirone for treatment of behavior disorders in children with phenylketonuria.

Many patients with late-diagnosed phenylketonuria (PKU) suffer from severe behavior problems. This study compares the effects of buspirone and risperidone on reducing behavior disorders in these patients. In this crossover clinical trial study, patients with severe behavior disorders after medical examination were randomly divided into two groups of two 8-week crossover treatments with risperidone or buspirone. Patient behavioral disorders before and after treatment by each drug was rated by parents on the Nisonger Child Behavior Rating Form (NCBRF), and after treatment by each drug, were assessed by a physician through clinical global impression (CGI). Thirteen patients were able to complete the therapy period with these two medications. The most common psychiatric diagnoses were intellectual disability accompanied by pervasive developmental disorder NOS, and intellectual disability accompanied by autistic disorder. Risperidone was significantly effective in reducing the NCBRF subscales of hyperactivity disruptive/stereotypic, and conduct problems. Treatment by buspirone only significantly decreased the severity of hyperactivity, but other behavior aspects showed no significant differences. Assessment of the severity of behavior disorder after treatment by risperidone and buspirone showed significant differences in reducing hyperactivity and masochistic/stereotype. Although buspirone is effective in controlling hyperactivity in patients with PKU, it has no preference over risperidone. Therefore, it is recommended as an alternative to risperidone.

What Does Risperidone Add to Parent Training and Stimulant for Severe Aggression in Child Attention-Deficit/Hyperactivity Disorder?

Although combination pharmacotherapy is common in child and adolescent psychiatry, there has been little research evaluating it. The value of adding risperidone to concurrent psychostimulant and parent training (PT) in behavior management for children with severe aggression was tested. One hundred sixty-eight children 6 to 12 years old (mean age 8.89 ± 2.01 years) with severe physical aggression were randomized to a 9-week trial of PT, stimulant (STIM), and placebo (Basic treatment; n= 84) or PT, STIM, and risperidone (Augmented treatment; n= 84). All had diagnoses of attention-deficit/hyperactivity disorder and oppositional-defiant disorder (n= 124) or conduct disorder (n= 44). Children received psychostimulant (usually Osmotic Release Oral System methylphenidate) for 3 weeks, titrated for optimal effect, while parents received PT. If there was room for improvement at the end of week 3, placebo or risperidone was added. Assessments included parent ratings on the Nisonger Child Behavior Rating Form (Disruptive-Total subscale was the primary outcome) and Antisocial Behavior Scale; blinded clinicians rated change on the Clinical Global Impressions scale. Compared with Basic treatment (PT+ STIM [44.8 ± 14.6mg/day]+ placebo [1.88 mg/day ± 0.72]), Augmented treatment (PT+ STIM [46.1 ± 16.8 mg/day]+ risperidone [1.65 mg/day ± 0.75]) showed statistically significant improvement onthe Nisonger Child Behavior Rating Form Disruptive-Total subscale (treatment-by-time interaction, p= .0016), the Nisonger Child Behavior Rating Form Social Competence subscale (p= .0049), and Antisocial Behavior Scale Reactive Aggression subscale (p= .01). Clinical Global Impressions scores weresubstantially improved for the 2 groups but did not discriminate between treatments (Clinical Global Impressions-Improvement score≤2, 70% forBasic treatment versus 79% for Augmented treatment). Prolactin elevations and gastrointestinal upset occurred more with Augmented treatment; other adverse events differed modestly from Basic treatment; weight gain in the Augmented treatment group was minor. Risperidone provided moderate butvariable improvement in aggressive and other seriously disruptive child behaviorswhenadded to PT and optimized stimulant treatment. Clinical trial registration information-Treatment of Severe Childhood Aggression (The TOSCA Study), URL: http://clinicaltrials.gov, unique identifier: NCT00796302.

The Behavior Problems Inventory‐Short Form for individuals with intellectual disabilities: Part II: reliability and validity

The Behavior Problems Inventory-01 (BPI-01) is an informant-based behaviour rating instrument for intellectual disabilities (ID) with 49 items and three sub-scales: Self-injurious Behavior, Stereotyped Behavior and Aggressive/Destructive Behavior. The Behavior Problems Inventory-Short Form (BPI-S) is a BPI-01 spin-off with 30 items. The psychometric properties of these two versions of the scale were computed using aggregated archival data from nine different sites in the USA, Wales, England, the Netherlands and Romania with a total of 1122 cases with a BPI-01 total score >0. The internal consistency of the BPI-01 and the BPI-S ranged from fair to excellent with the BPI-01 showing slightly stronger reliability. Construct validity (confirmatory and discriminant) was computed by comparing BPI sub-scale scores with the scores of four other behaviour rating scales (the Aberrant Behavior Checklist, the Diagnostic Assessment for the Severely Handicapped-II, the Nisonger Child Behavior Rating Form and the Inventory for Client and Agency Planning). Strong evidence for confirmatory and discriminant validity was found for both the BPI-01 and the BPI-S. Confirmatory fit indices for the BPI and the BPI-S were comparable and suggesting that the factor structures fit the data well. In summary, both BPI versions were found to be equally sound psychometrically and can be endorsed for future use. However, independent future studies are needed to replicate the psychometrics of the BPI-S with new data.

Platelet Vesicular Monoamine Transporter 2 Density in the Disruptive Behavior Disorders

In a former study, we reported decreased platelet vesicular monoamine transporter 2 (VMAT2) density (Bmax) in patients with ADHD. The current study aimed at measuring platelet VMAT2 in the disruptive behavior disorders (DBDs) to assess whether this finding is specific to ADHD or generalizable to the broader DBD concept. The study included 13 patients with DBDs aged 10-12 years and 16 healthy volunteers aged 8-17 years. All participants underwent a thorough clinical evaluation using Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version for diagnosis, the Nisonger Child Behavior Rating Form, the Clinical Global Impressions Scale-Severity version, and the DSM-IV ADHD Scale (DAS). The study group's DAS scores did not differ from those of the control group. There was no significant difference between the patients with DBDs and the control group either in VMAT2 density (Bmax) or affinity (Kd) as measured by high-affinity [(3)H]TBZOH binding. We conclude that the formerly reported decreased platelet VMAT2 Bmax in patients with ADHD may be specific to ADHD and not present in DBDs. Larger-scale replication is needed.

Evaluating the validity of the Nisonger Child Behavior Rating Form – Parent Version

Youth with intellectual and developmental disabilities (IDD) experience high rates of emotional and behavior problems. The Nisonger Child Behavior Rating Form (NCBRF) is one of the few tools developed to assess these problems in this population. It consists of a 10-item Social Competence section and a 66-item Problem Behavior section. The goal of this study was to examine the factorial, criterion, and convergent validity of the NCBRF. Data from individuals aged five to 18 years (n = 399) were submitted to confirmatory factor analysis (CFA). In addition, scores of different clinical groups (disruptive behavior disorders, mood/anxiety disorders, taking psychotropic medicines) were compared to youth with no significant clinical concerns and associations with Developmental Behavior Checklist (DBC) scores were examined in a subsample of participants. Results of the CFA indicated that the Social Competence subscales better fit the data (RMSEA = .056), than the Problem Behavior subscales (RMSEA = .086). Comparisons across clinical groups and correlations with DBC scores were significant and in the expected directions. This study supports the use of the NCBRF in youth with IDD, though the factor structure of the Problem Behavior section may need to be revisited.

Psychometric Evaluation of Romanian Translations of the Behavior Problems Inventory-01 and the Nisonger Child Behavior Rating Form

Psychometric properties of Romanian translations of the Behavior Problems Inventory-01 (BPI-01; Rojahn, Matson, Lott, Esbensen, & Smalls, 2001) and the Nisonger Child Behavior Rating Form (NCBRF; Aman, Tassé, Rojahn, & Hammer, 1996) were explored. Respondents completed the instruments for 115 children and adolescents with intellectual disabilities. Internal consistency of both instruments' total scales was good to excellent (Cronbach's α ranging from .88 to .95) and the subscale internal consistencies were fair to excellent (with α ranging from .74 to .94). The results based on bivariate Spearman correlations and multiple regression analyses provided strong convergent and discriminant validity of both instruments. Overall, the Romanian versions of the behavior rating scales had very good reliability (internal consistencies) and convergent and discriminant validity. It is hoped that this study will be a catalyst for Romanian clinicians and researchers as well as for transcultural researchers working with Romanian individuals with intellectual disabilities to continue the exploration of the utility and psychometric quality not only of the BPI-01 and the NCBRF but also of other English language psychopathology assessment instruments.

Psychometric Evaluation of the Behavior Problems Inventory-01 and the Nisonger Child Behavior Rating Form with Children and Adolescents

This study was conducted to assess the psychometric properties of 2 assessment instruments, the Behavior Problems Inventory-01 (BPI-01; Rojahn, Matson, Lott, Esbensen, & Smalls, 2001) and the Nisonger Child Behavior Rating Form (NCBRF; Aman, Tassé, Rojahn, & Hammer, 1996). The sample consisted of 237 ethnically diverse children and adolescents with intellectual disabilities who ranged in age from 4 to 22 years. Reliability parameters included internal consistency, interteacher agreement, teacher-parent agreement, and test-retest reliability. Factorial validity was assessed first by bivariate Spearman rank (ρ) correlations and then by examining the factor structure fit via confirmatory factor analysis (CFA). Convergent and discriminant validity was assessed by multiple regression analyses across the 2 instruments. Reliability coefficients (internal consistency, interteacher agreement, and test-retest reliability) of the BPI-01 and of the NCBRF subscales ranged from fair to excellent and from poor to excellent, respectively. The CFA suggested a poor fit between the present and the original BPI-01 and NCBRF factor structures, although item-total correlations were reasonable. Convergent and discriminant validity between the BPI-01 and the NCBRF, however, was strong. Limitations of the study are discussed and recommendations for future studies are presented.

Parenting Stress in Families of Children with Cornelia de Lange Syndrome and Down Syndrome

We assessed similarities and differences in self-reported stress (Parenting Stress Index: Short Form [PSI-SF]), patterns of challenging child behavior (Nisonger Child Behavior Rating Form [NCBRF]), and characteristics of autism (Gilliam Autism Rating Scale 2nd Edition [GARS-2]) across two distinct groups of children and young adults 5 to 24 years old: Cornelia de Lange Syndrome (CdLS, n = 25, Mage (SD) = 11.4 (4.7) years), and Down syndrome (DS, n = 23, Mage (SD) = 13.4 (6.0) years). Parents were recruited from the CdLS-USA Foundation and DS parent support groups across the United States. The study focused on identifying specific patterns of (a) parenting stress and (b) challenging behavior and autism-like characteristics in children with CdLS and DS. It was found that parents of CdLS children experienced far more stress than those of children with DS, and the difference could not be explained completely by demographic variables or children’s developmental level. Rather it appears that the especially elevated stress in parents of children with CdLS can be traced in significant part to the children’s high levels of challenging behavior, low levels of pro-social behavior, and self-injury / stereotypy. Additional results revealed that children with CdLS exhibited significantly higher levels of challenging behavior and autism-like characteristics, and lower levels of pro-social behavior, and appropriate communicative behaviors. Multivariate regression showed that optimum prediction of stress for the total sample was yielded by a combination of the child’s elevated self-injury / stereotypy and decreased social interaction skills (R2 = 0.217, R2adj = 0.182, pmodel = 0.004), and the addition of the child’s diagnosis significantly increased predictability, R2 = 0.273, R2adj = 0.223, pmodel = 0.003. The elevated stress in parents of children with CdLS appears to be focused primarily on their children’s specific difficult child behaviors, a factor that was of much less concern to parents of children with DS. Results are discussed in terms of a possible behavioral phenotype for CdLS and future research on early intervention for parenting stress. It is noted that parenting stress in the CdLS sample is so high as to be unmeasurable (i.e., ceiling effect) in a large minority of the parents, and this makes it an urgent priority to develop well-targeted early interventions for parenting stress in these families.

Effects of risperidone on cognitive-motor performance and motor movements in chronically medicated children

This study was designed to explore the placebo-controlled effects of risperidone on cognitive-motor processes, dyskinetic movements, and behavior in children receiving maintenance risperidone therapy. Sixteen children aged 4–14 years with disruptive behavior were randomly assigned to drug order in a crossover study of risperidone and placebo for 2 weeks each. Dependent measures included tests of sustained attention, memory, visual matching, tremor, seat activity, abnormal movements, and parent behavior ratings. Results were compared by repeated measures ANOVA. Fourteen boys and 2 girls with disruptive behavior and IQ ≤ 84 all completed the protocol. Risperidone was superior to placebo on response time ( p = 0.01, η P 2 = 0.43) and seat movement ( p < 0.05, η P 2 = 0.29) on a short-term memory task, and on a measure of static tremor ( p = 0.05, η P 2 = 0.28). There was not a significant difference between treatment conditions on the Abnormal Involuntary Movement scale. Risperidone was superior to placebo on three subscales of the Nisonger Child Behavior Rating Form [Overly Sensitive ( p < 0.01, η P 2 = 0.44), Conduct Problem ( p = 0.02, η P 2 = 0.36), Hyperactivity ( p = 0.03, η P 2 = 0.32)] and on the Hyperactivity/Noncompliance subscale of the Aberrant Behavior Checklist ( p = 0.01, η P 2 = 0.41). Significant increases in heart rate ( p = 0.05, η P 2 = 0.27) and weight ( p = 0.02, η P 2 = 0.36) occurred in the risperidone condition. The findings suggest a beneficial effect of risperidone after several months of treatment on efficiency of responding, activity level, static tremor, and aspects of behavior.

Treating Disruptive Behavior Disorders with Risperidone: A 1-Year, Open-Label Safety Study in Children and Adolescents

The aim of this study was to determine the long-term safety of risperidone as maintenance therapy in children and adolescents with disruptive behavior disorders (DBDs) and normal intelligence. An open-label, 1-year extension study was conducted from January, 2002, to July, 2004, in 232 subjects with DBDs (5-17 years) previously randomized to risperidone (RIS) (n = 115, RIS/RIS) or placebo (PLA) (n = 117, PLA/RIS) in a double-blind, 6-month withdrawal study. Adverse events (AEs) and clinical laboratory test results were recorded. Efficacy was assessed using Nisonger Child Behavior Rating Form. Safety and efficacy were evaluated in the intent-to-treat population. A total of 169/232 (73%) subjects completed the study. Subjects were predominantly male, with a diagnosis of oppositional defiant disorder. Risperidone was generally well tolerated. Weight gain and extrapyramidal symptoms were each reported as AEs by 10 subjects (4.3%). Mean weight z-scores decreased for RIS/RIS subjects (-0.04 +/- 0.28) and increased for PLA/RIS subjects (0.11 +/- 0.43). No subject developed tardive dyskinesia. Prolactin tended to increase with risperidone, although this effect diminished with prolonged use and was infrequently associated with AEs. There were no clinically relevant changes in glucose or lipid metabolism. Clinical improvement in DBD symptoms was observed with flexible risperidone doses, regardless of previous treatment and whether subjects had experienced symptom recurrence. Risperidone reinitiated for DBD in children with normal intelligence quotients (IQ) was safe and well tolerated over an additional year of treatment. Patients demonstrated clinical benefits, including those who previously experienced symptom recurrence.

The Nisonger Child Behavior Rating Form: typical IQ version

The Nisonger Child Behavior Rating Form (NCBRF) has been used in several large studies of risperidone in children with low IQs (36-84) and disruptive behavior disorders (conduct disorder and oppositional defiant disorder). We wanted to develop a companion instrument for assessing 'typically developing' children and adolescents. In this study, we modified the NCBRF and obtained parent ratings on 485 typically developing children attending regular classes. We also obtained parent ratings on 46 children with conduct disorder and oppositional defiant disorder. Factor analyses of the ratings produced a single Positive Social subscale (10 items) and six Problem Behavior subscales (54 items): (i) Conduct Problems, (ii) Oppositional, (iii) Hyperactive, (iv) Inattentive, (v) Withdrawn/Dysphoric, and (vi) Overly Sensitive. Comparison of the school and disruptive behavior disorder groups showed large and significant differences, providing evidence of criterion validity for the Conduct Problem and Oppositional subscales, and on a Disruptive Total composite. Analysis for age and sex effects showed no main effects and no interaction of age and sex. Norms were presented. The factor structure of problem behavior tends to differ in significant ways between typically developing children and children having developmental disabilities. Like its predecessor, the NCBRF-TIQ (for typical IQ) is in the public domain and is available free to researchers and clinicians for assessment and treatment.

A26-Week Open-Label Study of Quetiapine in Children with Conduct Disorder

The aim of this study was to describe the long-term safety and effectiveness of quetiapine in conduct disorder (CD). This was an 18-week outpatient follow-up study of an acute trial that enrolled aggressive children ages 6-12 years with a primary diagnosis of CD. To be enrolled into this study, subjects had to have successfully completed participation in the initial 8-week, open-label, outpatient quetiapine trial. Psychometric measures included the Rating of Aggression Against People and/or Property Scale (RAAPP), the Nisonger Child Behavior Rating Form (NCBRF), the Conners' Parent Rating Scale (CPRS-48), the Clinical Global Impressions Scale of Severity (CGI-S), and the Children's Global Assessment Scale. Nine males with a mean age of 8.9 (SD = 1.2) years were treated. The median quetiapine dose at end of study was 150 mg/day (range 75-350). Mean psychometric scores did not change substantively from baseline. No patients experienced extrapyramidal side effects. Three subjects discontinued due to study nonadherence. No patients discontinued treatment due to an adverse event. These preliminary data suggest that quetiapine might be a generally safe and effective maintenance treatment for aggressive children with CD who initially respond to an acute therapeutic trial of quetiapine. More research is needed to confirm or refute these initial findings.

Risperidone and Cognitive Function in Children With Disruptive Behavior Disorders

Effects of risperidone on cognitive function in children with disruptive behavior disorders (DBDs) and subaverage intelligence quotient (IQ) were assessed. Data from two 6-week, double-blind, placebo-controlled studies (n = 228) were combined, as were three 1-year, open-label studies (n = 688). Patients with DBDs and subaverage IQ, 5 to14 years, received placebo or risperidone .02 to .06 mg/kg/day. Cognitive measures included the Continuous Performance Task (CPT) and Verbal Learning Test for Children (VLT-C). Efficacy was assessed using the Nisonger Child Behavior Rating Form (NCBRF). Adverse events were collected via spontaneous report; sedation was assessed using visual analog scale. Improvements on the NCBRF Conduct Problem subscale were significantly greater for risperidone- versus placebo-treated patients (-15.8 vs. -6.4, p < .0001) in short-term studies; significant reductions were observed in long-term studies (-16.3, p < .0001). No overall decline and some significant improvement in attention (CPT) and memory (VLT-C) were noted regardless of treatment in short-term studies. VLT-C improved significantly (p < .0001) for both groups, with no difference between treatment groups. Improvements in memory (VLT-C) and attention (CPT) were noted in long-term studies. Somnolence/sedation did not affect cognitive function. Cognitive function was not altered by risperidone in short-term studies and was maintained or improved with one year of treatment in children with DBDs and subaverage IQ, potentially representing age-appropriate gains.

Behavioral and Emotional Problems in Young People with Pervasive Developmental Disorders: Relative Prevalence, Effects of Subject Characteristics, and Empirical Classification

Parents or teachers rated 487 non-clinically referred young people with Pervasive Developmental Disorders on the Nisonger Child Behavior Rating Form. The objectives of the study were to examine the relative prevalence of specific behavior problems, assess the impact of subject characteristics, and derive an empirical classification of behavioral and emotional problems for this population. Results indicated that the youngsters experienced high rates of behavior and emotional problems. Cluster analysis suggested that six- and eight-cluster solutions best fit the ratings provided by parents and teachers, respectively. Both parent and teacher cluster solutions contained groups of children characterized as problem free, well adapted, hyperactive, anxious, and with undifferentiated behavior disturbances. The empirically derived clusters were supported by data external to the analyses.

Effectiveness, Safety, and Pharmacokinetics of Quetiapine in Aggressive Children With Conduct Disorder

To provide an initial description of the effectiveness and pharmacokinetics (PK) of quetiapine in aggressive children with conduct disorder (CD). This 8-week, open-label outpatient trial, enrolled patients ages 6 to 12 years with CD. Outcome measures included the Rating of Aggression Against People and/or Property Scale (RAAPPS), Nisonger Child Behavior Rating Form (NCBRF), and the Conners Parent Rating Scale (CPRS-48). Blood sampling for PK analyses occurred at the end of weeks 2 and 8. Seventeen children (16 boys, mean age 8.9 years) were treated. The mean dose at week 8 was 4.4 mg/kg (SD = 1.1 mg/kg). Significant decreases in the baseline scores of the RAAPPS, and several subscales of the NCBRF and the CPRS were found by the end of the study (p <.05). No patients discontinued because of an adverse event. No patients experienced extrapyramidal side effects. Quetiapine disposition was linear over the dose range studied. The elimination half-life of the drug averaged 3.9 and 2.9 hours and total body clearance averaged 3.5 and 3.0 L/hr/kg after study weeks 2 and 8, respectively. These preliminary data suggest that aggressive children with CD may benefit from quetiapine. The PK of quetiapine supports twice-daily dosing in children with CD.

Long-Term Use of Risperidone in Children with Disruptive Behavior Disorders and Subaverage Intelligence: Efficacy, Safety, and Tolerability

The aim of this study was to assess the long-term efficacy and tolerability of risperidone in the treatment of children and adolescents with disruptive behavior disorder (DBD) and below-average intelligence (IQ < 84) over a cumulative period of 2 years. We followed 48 patients (6-15 years of age), who had previously completed a 1- year open-label study of risperidone, for an additional year of treatment. Efficacy was assessed using the conduct problem subscale of the Nisonger Child Behavior Rating Form (N-CBRF) as a primary outcome measure; other N-CBRF subscales, the Aberrant Behavior Checklist (ABC), and the Clinical Global Impression (CGI) of severity were secondary efficacy measures. Safety and tolerability were also assessed. Of the 48 patients enrolled in this extension study, 33 (69%) completed the trial. The efficacy benefits from the original study were maintained over the course of the extension study. Safety and tolerability were good overall, with the number of adverse events (AEs) decreasing in the extension trial, compared to the original trial. Six patients (13%) discontinued owing to AEs. Weight gain observed in the original trial stabilized during this extension trial. Cognitive testing demonstrated small, but significant, improvements in cognitive ability. Risperidone is safe and effective in treating DBDs in children over a cumulative period of 2 years.

Risperidone for the treatment of affective symptoms in children with disruptive behavior disorder: A post hoc analysis of data from a 6-week, multicenter, randomized, double-blind, parallel-arm study

Background: Despite the increasing recognition of bipolar disorder in childhood, there have been no controlled, randomized clinical trials of atypical antipsychotics in this population. Preliminary data from open-label trials in children suggest that these agents might be effective in treating pediatric bipolar disorder, however. Objective: The purpose of this post hoc analysis of data from Aman et al was to determine the effects of risperidone in the management of affective symptoms in children with disruptive behavioral disorders (DBDs). Methods: This report presents a secondary analysis of a previously reported 6-week, multicenter, double-blind, randomized, parallel-arm trial comparing 6 weeks of administration of risperidone (flexible dosing starting at 0.02 mg · kg ·1 · d −1 and titrated up to 0.06 mg kg −1 d −1) versus placebo in children with DBDs and subaverage intelligence. Twenty-four candidate affective symptoms of mania and depression were extracted from the 64-item Nisonger Child Behavior Rating Form (NCBRF). To define independent dimensions of mood-disorder psychopathology, these 24 symptoms were assigned 1 of 3 independent dimensions (symptoms of mania) based on loading: explosive irritability; agitated, expansive, grandiose; and depression. A fourth, nonaffective independent dimension encompassed a combination of nonaffec tive symptoms on the NCBRF Conduct Problem subscale. To assess treatment effect, each independent dimension was assigned a score derived from the sum of the symptoms that loaded on that dimension at weeks 2, 4, and 6 of study drug administration. Results: A total of 110 patients were included in the independent-dimension analysis (89 boys, 21 girls; risperidone, 49 patients; placebo, 61 patients; mean [SD] age, 8.6 [2.3] and 8.1 [2.4] years in the risperidone and placebo groups, respectively; mean [SD] weight, 33.9 [12.8] and 32.1 [12.0] kg in the risperidone and placebo groups, respectively). The treatment-effect analysis found that the mean scores of all 3 independent dimensions were significantly reduced with risperidone compared with placebo at weeks 2, 4, and 6 (all, P ≤ 0.03). The effect sizes of improvement in these factors ranXged from 0.44 to 0.95 at end point. Conclusions: The results of this post hoc analysis of affective symptoms of DBDs using data from a previously published randomized, double-blind clinical comparison of risperidone and placebo in the treatment of children with DBDs and subaverage intelligence suggest that risperidone was effective in treating the factors of explosive irritability; agitated, expansive, grandiose; and depression.

A Randomized, Double-Blind, Placebo-Controlled Study of Risperidone Maintenance Treatment in Children and Adolescents With Disruptive Behavior Disorders

The authors compared the effects of maintenance versus withdrawal of risperidone treatment in children and adolescents with symptoms of disruptive behavior disorder. Patients with disruptive behavior disorder (5-17 years of age and a range of intellect) who had responded to risperidone treatment over 12 weeks were randomly assigned to 6 months of double-blind treatment with either risperidone or placebo. The primary efficacy measure was time to symptom recurrence, defined as sustained deterioration on either the Clinical Global Impression severity rating (/2 points) or the conduct problem subscale of the Nisonger Child Behavior Rating Form (/7 points). Secondary efficacy measures included rates of discontinuation due to symptom recurrence, disruptive behavior disorder symptoms, and general function. Safety and tolerability were also assessed. Risperidone dosage was based on weight (patients <50 kg: 0.25-0.75 mg/day; patients /50 kg: 0.5-1.5 mg/day). Treatment was initiated in 527 patients, with 335 randomly assigned to a double-blind maintenance condition. Time to symptom recurrence was significantly longer in patients who continued risperidone treatment than in those switched to placebo. Symptom recurrence in 25% of patients occurred after 119 days with risperidone and 37 days with placebo. Secondary efficacy measures also favored risperidone over placebo. Weight increased over the initial 12 weeks of treatment (mean weight z score change=0.2, SD=2.7, N=511), after which it plateaued. This study is the first placebo-controlled maintenance versus withdrawal trial of its kind in disruptive behavior disorder and provides evidence that patients who respond to initial treatment with risperidone would benefit from continuous treatment over the longer term.