Government initiatives in autism clinical trials

Randomized clinical trials remain the most valid method of testing the efficacy and safety of treatments. While efforts to elucidate the genetic and neurodevelopmental bases of autism are underway, clinicians and families are in need of scientifically valid information on how to best treat patients with autism. The effectiveness of many interventions currently used in communities has not been adequately tested. Given the high public health relevance of autism treatment research and the low interest of the pharmaceutical industry in autism, the role of the National Institutes of Health in supporting this research is paramount. Among recently launched initiatives in autism clinical trials, there are the Research Units on Pediatric Psychopharmacology Autism Network and the network of centers for Studies to Advance Autism Research and Treatment. These and other government activities in the area of autism clinical trials are here briefly reviewed.     

Impact of recent findings on study design of future autism clinical trials

There are specific challenges to studying the design of pharmacologic trials in child/adolescent and adult autism, such as subject stratification and parallel versus crossover designs. This article describes how optimal study design is influenced by subject selection and outcome measures chosen. Lessons learned in study design from the Research Units on Pediatric Psychopharmacology Autism Network trial with risperidone, Seaver Center trials with fluoxetine and valproate, Dartmouth trials with amantadine, and National Institutes of Health secretin trials are highlighted. The Internet System for Assessing Autistic Children system for managing multicenter clinical trials in autism and statistical issues in autism research are also described.     

Developmental changes in facial expressions of emotions in the strange situation during the second year of life

Infants' expressions of discrete emotions were coded during the more stressful episodes (4 through 8) of the Strange Situation at 13 and 18 months. The data showed a significant decrease in full-face expressions (more complex configurations of movements) and a significant increase in component expressions (simpler and more constrained patterns of movements). The authors interpreted this trend as a developmental change toward more regulated and less intense emotions. Consistent with this view, the aggregate index of infants' full-face negative emotion expressions, interpreted as reflecting relatively unregulated intense emotions, correlated significantly with maternal ratings of difficult temperament. The authors discuss alternative interpretations of the findings in terms of changes in reactivity/arousability and the emerging capacity for self-regulation.     

Accuracy of blood glucose estimation by children with diabetes: an investigation of repeated practice with growth curve modeling

This study used growth curve modeling to explore whether practicing the task of estimating blood glucose levels would increase accuracy in children with type 1 diabetes. It was predicted that accuracy would improve with practice and that younger, anxious, poorly adjusted children would improve most. 43 attendees at a diabetes summer camp participated. Their mean age was 13.4 yr. (SD = 1.6). All were Euro-American, and 22 were girls. Change in accuracy was best represented by a quadratic function, and this model fit the data well. Overall, participants' accuracy improved initially and then deteriorated. Results indicate that older children were more likely to improve and then deteriorate. Younger children were more likely to improve and sustain those improvements. Results indicate that practicing the task of estimating is not an effective way to increase accuracy and may be contra-indicated. These results can help guide research and clinical use of glucose estimation in children.     

Social anxiety in stuttering: measuring negative social expectancies

Much research has suggested that those who stutter are likely to be anxious. However, to date, little research on this topic has addressed the role of expectancies of harm in anxiety, which is a central construct of anxiety in modern clinical psychology. There are good reasons to believe that the anxiety of those who stutter is related to expectancies of social harm. Therefore, in the present study, 34 stuttering and 34 control participants completed the Fear of Negative Evaluation (FNE) Scale and the Endler Multidimensional Anxiety Scales-Trait (EMAS-T). The FNE data showed a significant difference between the stuttering and control participants, with a large effect size. Results suggested that, as a group, a clinical population of people who stutter has anxiety that is restricted to the social domain. For the EMAS-T, significant differences between groups were obtained for the two subtests that refer specifically to people and social interactions in which social evaluation might occur (Social Evaluation and New/Strange Situations) but not for the subtests that contained no specific reference to people and social interactions (Physical Danger and Daily Routines). These results were taken to suggest that those who stutter differ from control subjects in their expectation of negative social evaluation, and that the effect sizes are clinically significant. The findings also suggest that the FNE and the EMAS-T are appropriate psychological tests of anxiety to use with stuttering clients in clinical settings. The clinical and research implications of these findings are discussed, in terms of whether social anxiety mediates stuttering or is a simple by-product of stuttering. Possible laboratory explorations of this issue are suggested, and potential Cognitive Behavior Therapy packages for stuttering clients who might need them are discussed. EDUCATIONAL OBJECTIVES: The reader will be able to: (1) explain why expectancy of social threat or harm may be associated with stuttering; (2) name and describe two psychological tests that are suitable for assessment of the social threat or harm that may be associated with stuttering; and (3) explain how findings for the EMAS-T test in the present results suggest that expectancy of social threat or harm, but not other kinds of negative expectancy, are associated with stuttering.     

Reducing the drop-out rates of at-risk high school students: the Effective Learning Program (ELP)

The purpose of the present study was to evaluate the effectiveness of the Effective Learning Program (ELP) with students who are at high risk for dropping out of high school. The intervention sought to change external control expectancies to more internal ones, improve students' skills in building relationships with peers and adults, and increase graduation rates. Thirty-eight students considered at risk for dropping out of high school received the intervention. In addition, ELP-eligible students who did not receive the ELP intervention (n = 36) and regular education students (n = 50) from the same high school were compared with the students who received the ELP. A significantly greater percentage of ELP students graduated, became more internally controlled, achieved more as shown by standardized tests, and developed greater social skills and better relationships than their ELP-eligible but nonparticipating peers. The authors suggest that researchers identify which aspects of the ELP are responsible for the improvement in retention, achievement, and personal attributes.     

A categorical and dimensional perspective on depression within a nonclinical sample of couples

The present study investigated the role of psychosocial variables that are indicators for depressive symptomatology within a couple. The variables chosen for this study were conflict communication, marital adjustment, attachment, attribution style, and personality traits--all potentially specific indicators. A global factor analysis on all our measures revealed that our individual and relational measures were stable findings. We wanted to compare a dimensional and categorical view of depression. First, we focused on the total nonclinical sample, considering depression on a continuum, and studying the selected characteristics along with the varying degree of depressive complaints. The results highlighted the importance of individual characteristics (neuroticism and life satisfaction) covarying with the level of depressive symptomatology in the nonclinical sample (n = 186 couples). Second, in addition to this correlational design, we compared the group of most depressed subjects and their partners with a control sample (n = 34). Both approaches pointed to the same conclusion: individual characteristics covaried with mild depression, whereas couple characteristics only came into the picture with a higher level of depressive complaints. The lowest levels of depressive complaints were associated with individual co-morbidity only, whereas increasing complaints went along with additional relational complaints. Implications for assessment and future research are discussed.     

Effects of the terrorist attacks of 9/11/01 on employee attitudes

Much has been stated in the popular press about the effects of the events of 9/11/01 on employee attitudes about work. This study examined a large sample (N = 70,671) of employees of a multinational manufacturer whose annual employee survey data collection was interrupted by the events. After demonstrating measurement equivalence across time and countries, changes in attitudes pre- and post-9/11 were examined. Only negligible differences were found in Job Satisfaction, Supervisor Evaluation, Stress, and Organizational Commitment to Diversity for U.S. employees or for employees worldwide. Demographic differences in response to events were not found. Implications for understanding effects of stressful external events on employee perceptions of work are discussed.