Faculty Bibliography

Treatment studies in child and adolescent psychiatry are increasingly characterized by long-term, multisite, randomized clinical trials (RCTs). During the course of these RCTs it is common for clinical exigencies to emerge that require rapid, direct intervention. The challenge is to provide clinically appropriate responses that do not contaminate the delivery, distinctness, and interpretation of the treatments under investigation. In multisite studies, the problem is compounded by the need to minimize cross-site differences in the delivery of adjunct treatments. Such minimization requires fully operationalized and manual-based procedures for clinically mandated intervention. The NIMH Collaborative Multisite Multimodal Treatment Study of Children With Attention-Deficit/Hyperactivity Disorder (ADHD)--'the MTA'--is a long-term multisite collaborative study in which children with ADHD were randomly assigned to either medication management, behavioral treatment, the combination, or community-comparison assessment and referral. In designing its study, the MTA developed a manual-based set of procedures (the MTA Adjunct Services and Attrition Prevention [ASAP] Manual) for situations not covered by the protocol treatments. The majority of cases requiring adjunct services fell into two major categories: (1) crisis/emergent situations and (2) imminent risk of attrition. This report describes the ASAP guidelines for dealing with cases that required adjunct services that the MTA Steering Committee adopted before initiating the trial. Although the manual-based guidelines are especially applicable to multisite RCTs, many of the procedures in the ASAP Manual can apply to any treatment study in children

Presents a consensus statement on attention deficit hyperactivity disorder (ADHD) as a reference on the status of scientific findings concerning this disorder, its validity, and its adverse impact on the lives of those diagnosed with the disorder. It is emphasized that, as a matter of science, the notion that ADHD does not exist is simply wrong. The international scientists authoring this consensus recognize the mounting evidence of neurological and genetic contributions to ADHD. This evidence, couples with countless studies on the harm posed by ADHD and studies on the effectiveness of medication, highlight the need in many cases for management of the disorder with multiple therapies. Despite the serious consequences of ADHD, studies indicate that less than half of those with the disorder are receiving treatment. The media can help by depicting ADHD as realistically and accurately as it is depicted in science--as a valid disorder having varied and substantial adverse impact on those who suffer from it.

OBJECTIVE: To explore whether socioeconomic status (SES) variables moderate treatment response of attention-deficit/hyperactivity disorder (ADHD) to medication management (MedMgt), behavioral treatment (Beh), combined intervention (Comb), and routine community care (CC). METHOD: The MTA Cooperative Group's intent-to-treat (ITT) analyses were repeated, covarying for composite Hollingshead SES, education, occupation, income, and marital status. RESULTS: Individual SES variables were more informative than the composite Hollingshead Index. Treatment response of children from less educated households paralleled ITT outcomes: no significant difference was found between Comb and MedMgt (both better than Beh and CC) for core ADHD symptoms. However, children from more educated families showed superior reduction of ADHD symptoms with Comb. For oppositional-aggressive symptoms, children from blue-collar, lower SES households benefited most from Comb, whereas those from white-collar, higher SES homes generally showed no differential treatment response. Household income and marital status failed to influence outcomes. Controlling for treatment attendance attenuated the moderating effects of the SES variables only for MedMgt. CONCLUSIONS: Investigators are encouraged to use independent SES variables for maximal explanation of SES effects. Clinicians should prioritize target symptoms and consider the mediating role of treatment adherence when determining an ADHD patient's optimal intervention plan

This study evaluated children's symptoms 3 and 9 months after the 1993 bombing of the World Trade Center, and the relationship between parent and child reactions when only the children had been in the building. Nine children who had been trapped in an elevator, 13 who had been on the observation deck, and 27 controls completed the Posttraumatic Stress Reaction Index and a Fear Inventory. Parents completed these measures about the children and comparable measures about themselves. Exposed children reported posttraumatic stress disorder (PTSD) symptoms and disaster-related fears; their parents reported experiencing PTSD symptoms. Only parents rated children's symptoms as decreasing significantly over time. Association between child symptoms and parent symptoms increased over time. Children's initial distress predicted parents' distress 9 months postdisaster

BACKGROUND: An 8-week placebo-controlled study, the Research Units on Pediatric Psychopharmacology Anxiety Study, documented beneficial effects of fluvoxamine in the treatment of pediatric social anxiety, separation anxiety, or generalized anxiety disorders. Following completion of this study, participants were invited to enter a 6-month open-label treatment phase designed to examine three issues: (a) long-term maintenance of response in fluvoxamine responders, (b) acute response to fluoxetine in fluvoxamine nonresponders, and (c) acute response to fluvoxamine in placebo nonresponders. METHODS: Participants aged 6-17 years meeting criteria for social anxiety, separation anxiety, or generalized anxiety disorders previously treated in an 8-week placebo-controlled trial (n = 128) were offered open treatment. Changes in symptoms of anxiety during open treatment were assessed in three groups: (a) fluvoxamine responders maintained on fluvoxamine, (b) fluvoxamine nonresponders changed to fluoxetine, and (c) placebo nonresponders changed to fluvoxamine. Response was defined based on Clinical Global Impression criteria. RESULTS: During 6 months of continued open treatment, anxiety symptoms remained low in 33 of 35 (94%) subjects who initially responded to fluvoxamine. Among 14 fluvoxamine nonresponders switched to fluoxetine, anxiety symptoms appeared significantly improved in 10 (71%) subjects. Finally, among 48 placebo nonresponders, 27 (56%) showed clinically significant improvement in anxiety on fluvoxamine. CONCLUSION: The current findings concerning extended treatment of pediatric anxiety disorders are only preliminary, because treatment was uncontrolled. Results suggest that an initial fluvoxamine response is likely to be retained with continued treatment, that some fluvoxamine nonresponders may respond to fluoxetine, and that some placebo nonresponders may respond to fluvoxamine

Discusses challenges involved in the collection of safety information on psychotropic medications when administered to children and adolescents, and suggests methods for improving existing approaches. Current methods for collecting and assessing safety data during pediatric psychopharmacological trials are critiqued and possible alternatives are reviewed. It is concluded that methods used for collecting and assessing drug safety data remain less sophisticated than efficacy evaluations. Multisite trials, although demonstrating statistical power to detect placebo/active drug differences, remain too small to detect infrequent but serious drug-related adverse events. Other active surveillance approaches, such as long-duration follow-up studies and clinical epidemiological studies, using case-control, cohort designs, or trend analysis of population-based treatment data must be used. (PsycIN

Impulsivity is a primary symptom of the combined type of Attention Deficit/Hyperactivity Disorder (AD/HD). The Stop Signal Paradigm is premised upon a primary deficit in inhibitory control in AD/HD, whereas the Delay Aversion Hypothesis, by contrast, conceptualizes impulsivity in AD/HD, not as an inability to inhibit a response, but rather as a choice to avoid delay. This study compared the ecological validity of the Stop Signal Task (SST) and Choice-Delay Task (C-DT) measure of delay aversion, with respect to their relative utility in discriminating AD/HD children from normal control participants, and their correlations with classroom observations and with ratings of impulsivity and other core AD/HD symptoms on the Conners and SNAP-IV checklists. The tasks exhibited modest discriminant validity when used individually and excellent discriminant validity when used in combination. The C-DT correlated with teacher ratings of impulsivity, hyperactivity, and conduct problems, and with observations of gross motor activity, physical aggression, and an AD/HD composite score. The SST correlated with the observations only. These results suggest that delay aversion is associated with a broad range of AD/HD characteristics whereas inhibitory failure seems to tap a more discrete dimension of executive control

Drugs that selectively inhibit serotonin reuptake are effective treatments for adults with mood and anxiety disorders, but limited data are available on the safety and efficacy of serotonin-reuptake inhibitors in children with anxiety disorders. 128 children (aged 6-17 yrs) who met the criteria for social phobia, separation anxiety disorder, or generalized anxiety disorder, and who had received psychological treatment for 3 wks without improvement were studied. The children were randomly assigned to receive fluvoxamine or placebo for 8 wks and were evaluated with rating scales designed to assess the degree of anxiety and impairment. Children in the fluvoxamine group had a mean decrease of 9.7 points in symptoms of anxiety on the Pediatric Anxiety Rating Scale, as compared with a decrease of 3.1 points among children in the placebo group. On the Clinical Global Impressions-Improvement scale, 48 of 63 children in the fluvoxamine group had a response to the treatment, as compared with 19 of 65 children in the placebo group. It is concluded that fluvoxamine is an effective treatment for children and adolescents with social phobia, separation anxiety disorder, or generalized anxiety disorder.