Healthy subjects volunteering for Phase I studies: influence of curiosity, exploratory tendencies and perceived self-efficacy.

OBJECTIVE: To test the hypothesis that trait-curiosity and perceived self-efficacy influence the willingness of healthy subjects to volunteer for participation in Phase I studies. MATERIALS AND METHODS: A group of healthy subjects who had never participated in clinical studies ("index group") were invited to participate in a Phase I study. They were assessed with regard to trait curiosity (Curiosity and Exploration Inventory; CEI-T) and perceived self-efficacy (Self-Efficacy Scale; SES) and subjects who accepted the invitation to participate were compared with those who refused and with a group of healthy subjects who had previously participated in clinical studies ("validation group"). RESULTS: A significant positive correlation was found between the willingness to participate and the CEI-T total score (R=0.28; p<0.01), exploratory tendencies (R=0.34; p<0.001), SES total score (R=0.30, p<0.01), initiative and persistence (R=0.29, p<0.01), planning/goal setting (R=0.19, p<0.05) and social self-efficacy (R=0.29; p<0.01). The "index group" subjects who accepted the invitation to participate showed significantly greater CEI-T exploratory tendencies (Z=-3.334, p = 0.001, Mann-Whitney test) and total scores (Z=-2.703, p<0.01) and greater SES total score (Z=-3.131, p<0.01), initiative and persistence (Z=-3.065, p<0.01), planning/goal setting (Z=-2.173, p<0.05) and social self-efficacy (Z=-2.954, p<0.01) than subjects who refused. No differences were found between the subjects in the "index group" who accepted the invitation and subjects in the "validation group". Using a logistic regression model, both CEI-T exploratory tendencies and SES initiative/persistence were significant predictors of participation. CONCLUSION: Subjects higher in curiosity/exploration and in perceived initiative/persistence are more willing to volunteer for Phase I studies. The impact of these self-selection biases on Phase I study results is unknown but deserves further evaluation.

Social anxiety disorder in childhood and adolescence: current status and future directions.

This paper reviews the current status of research on the phenomenology, etiology, maintenance, assessment, and treatment of childhood and adolescent social anxiety disorder (SAD). Despite being one of the most prevalent disorders of childhood and adolescence, SAD paradoxically stands as one of the least recognized, researched, and treated pediatric disorders. The small treatment outcome literature provides preliminary support to the effectiveness of various forms of cognitive behavior therapy. The majority of studies to date, however, are limited by inadequate control conditions. Other findings include some support for the utility of parental involvement in treatment, significant advancements in outcome measures (e.g., normative comparisons, indices of naturalistic social functioning), and impressive durability of gains for the majority of treatments. Future directions are suggested, including experimental and naturalistic studies of developmental pathways and maintenance factors, the incorporation of "positive psychology" constructs (e.g., positive emotions, hope, self-control) in treatment and prevention, and the continued delineation of differences between child, adolescent, and adult manifestations of SAD.