Participant satisfaction in a study of stimulant, parent training, and risperidone in children with severe physical aggression.

OBJECTIVE: The purpose of this study was to examine the satisfaction of families who participated in the Treatment of Severe Childhood Aggression (TOSCA) study. METHODS: TOSCA was a randomized clinical trial of psychostimulant plus parent training plus placebo (basic treatment) versus psychostimulant plus parent training plus risperidone (augmented treatment) for children with severe physical aggression, disruptive behavior disorder, and attention-deficit/hyperactivity disorder. Parents completed a standardized Parent Satisfaction Questionnaire (PSQ). RESULTS: Of the 168 families randomized, 150 (89.3%) provided consumer satisfaction data. When they were asked if they would join the study again if they had the option to repeat, 136 (91%) said "yes," 11 (7%) said "maybe," and one (<1%) said "no." When asked if they would recommend the study to other parents with children having similar problems, 147 (98%) said "yes" and 3 (2%) said "maybe." Between 71% (rating one aspect of the Parent Training) and 96% (regarding the diagnostic interview) endorsed study procedures using the most positive response option. Asked if there were certain aspects of the study that they especially liked, 64 (43%) spontaneously reported parent training. Treatment assignment (basic vs. augmented) and responder status were not associated with reported satisfaction. However, responder status was strongly associated with parent confidence in managing present (p<0.001) and future (p<0.005) problem behaviors. CONCLUSIONS: These findings indicate high levels of satisfaction with TOSCA study involvement and, taken together with previous pediatric psychopharmacology social validity studies, suggest high levels of support for the research experience. These findings may inform research bioethics and may have implications for deliberations of institutional review boards. TRIAL REGISTRY: Treatment of Severe Childhood Aggression (The TOSCA Study), NCT00796302, clinicaltrials.gov .

Aripiprazole in children with attention-deficit/hyperactivity disorder.

OBJECTIVE: To examine the effectiveness and cognitive effects of aripiprazole (APZ) in children with a primary diagnosis of attention-deficit/hyperactivity disorder (ADHD). METHODS: Youths, ages 8-12 years, with a diagnosis of ADHD combined-type or ADHD predominately inattentive-type were enrolled into a 6-week, open-label pilot trial. Outcome measures included the ADHD Rating Scale-IV (ARS-IV), Clinical Global Impressions Scale (CGI), and Children's Global Assessment Scale (CGAS). The Conners' Continuous Performance Test II, Reading and Math Fluency subscales of the Woodcock-Johnson III Tests of Achievement, and the Stroop Color and Word Test were administered at baseline and end of study. RESULTS: Fourteen (9 males and 5 females) youths were diagnosed with ADHD-combined type, while 9 (5 males and 4 females) were diagnosed with ADHD-inattentive type. At a mean dose of 6.7 mg/day, end of study results showed overall significant improvement from baseline on ADHD and functional outcome measures. No significant differences in baseline performance at end of study were found on the cognitive measures. The most frequently reported adverse events were sedation (n = 18; 78.3%) and headache (n = 11; 47.8%). CONCLUSIONS: Although this was a brief pilot study with a small sample size, in this cohort, APZ led to clinical benefit in reducing ADHD symptoms and improving overall functioning. Of note, cognitive functioning did not appear to be negatively impacted by APZ treatment.

Current research in child and adolescent bipolar disorder.

Although recently more research has considered children with bipolar disorder than in the past, much controversy still surrounds the validity of the diagnosis. Furthermore, questions remain as to whether or not childhood expressions of bipolarity are continuous with adult manifestations of the illness. In order to advance current knowledge of bipolar disorders in children, researchers have begun to conduct phenomenological, longitudinal, treatment, and neuroimaging studies in youths who exhibit symptoms of bipolar illness, as well as offspring of parents with bipolar disorders. Regardless of the differences between research groups regarding how bipolar disorder in children is defined, it is agreed that pediatric bipolarity is a serious and pernicious illness. With early intervention during the period of time in which youths are exhibiting subsyndromal symptoms of pediatric bipolarity, it appears that the progression of the illness to the more malignant manifestation of the disorder may be avoided. This paper will review what is currently known and what still is left to learn about clinically salient topics that pertain to bipolar disorder in children and adolescents.

Family conflict moderates response to pharmacological intervention in pediatric bipolar disorder.

OBJECTIVE: Family conflict affects the expression of psychopathology in youth. This study investigated whether family conflict moderates response to medication in youth with bipolar disorder. METHODS: Youth ages 5-17 years diagnosed with bipolar I or II disorder were recruited from a trial of combination therapy with divalproex and lithium. Mania and depression were assessed at baseline and after 8 weeks of treatment using the Young Mania Rating Scale (YMRS) and the Children's Depression Rating Scale-Revised (CDRS-R). Parents completed the Family Assessment Device (FAD). Ordinary least-squares regression evaluated whether family conflict contributed to YMRS/CDRS-R outcomes controlling for severity of baseline mood. RESULTS: In 55 youths, the model examining family conflict and CDRS-R outcomes showed that family conflict variables accounted for 10% of the variance in CDRS-R scores after 8 weeks of treatment. The final model was statistically significant. The FAD Problem Solving subscale was the only uniquely significant predictor of CDRS-R scores after 8 weeks of treatment. Family conflict did not predict YMRS outcomes. CONCLUSION: There is a significant relationship between family problem solving and depressive symptoms that persist despite pharmacotherapy. Although depression severity was mild at baseline, it persisted despite pharmacological treatment in youths whose families endorsed higher levels of conflict.

Update on pediatric bipolar disorder.

Children and adolescents with a bipolar disorder experience mood dysregulation that is often chronic with little interepisodic recovery. Although bipolar disorder in youth is recognized by more and more clinicians, much is still not known regarding how best to accurately diagnose and effectively treat it. As a result, children and adolescents with bipolar disorder are often symptomatic for long periods of time before receiving appropriate treatment. In this review of the pediatric bipolar disorder literature, the phenomenology, longitudinal course, and risk factors associated with the illness' development are discussed. Also, recent research pertaining to neuroimaging and pharmacologic and psychological treatments are considered. Because pediatric bipolar disorder is such a pernicious condition, it is recommended that clinicians complete a careful assessment of mood symptoms and comorbid conditions when this illness is suspected so that they can provide treatments with the best chance of benefit in a timely manner.