3 resultados para phase 2 clinical trial

em Digital Commons at Florida International University


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The present study pursued two objectives in the context of a randomized clinical trial of cognitive-behavioral therapy with parent (CBT/P) and group (GCBT) involvement. The first objective was to examine the variability in treatment outcome. There were three specific aims within the first objective, to evaluate: (1) youth characteristics (age, depressive, and externalizing disorders) as moderators of treatment outcome; (2) the differential outcome of the treatment approaches as a function of youth characteristics; and (3) the relative efficacy of the treatment approaches at each level of the moderators. ^ The second objective was to evaluate the efficacy of anxiety treatments along secondary depressive symptoms and externalizing behaviors. There were five specific aims within the second objective, to evaluate: (1) whether anxiety treatment yields reductions in secondary problems, (2) the efficacy of anxiety treatments in reducing secondary problems as a function of approach and youth characteristics, (3) whether reductions in anxiety symptoms significantly mediate changes in secondary problems, (4) the directionality of change in the hypothesized mediated relations, and (5) whether the hypothesized mediated relations are moderated by treatment approach and youth characteristics. The specific aims were pursued using data collected from 183 youth and their mothers. Research questions were tested using multiple regressions and structural equation modeling. ^ Age, depressive, and externalizing disorders were significant moderators. CBT/P relative to GCBT lowered anxiety more for younger than older youth. GCBT relative to CBT/P lowered anxiety more for older than younger youth. GCBT relative to CBT/P lowered anxiety more for depressed youth than non-depressed youth. GCBT relative to CBT/P lowered anxiety less for externalizing youth than non-externalizing youth. Treatment reduced depressive symptoms and externalizing problem behaviors. Reductions in anxiety mediated changes in depressive symptoms and externalizing problem behaviors. Reversed directionality was found in the relation between social anxiety and depressive symptoms. In CBT/P the direction of change was from depressive to social anxiety. The opposite was true in GCBT. Reductions in social anxiety mediated posttreatment changes in depressive symptoms in GCBT but not CBT/P. The reverse was true at follow-up. Reductions in social anxiety mediated changes in depressive symptoms for girls but not boys.^

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Context: Accurately determining hydration status is a preventative measure for exertional heat illnesses (EHI). Objective: To determine the validity of various field measures of urine specific gravity (Usg) compared to laboratory instruments. Design: Observational research design to compare measures of hydration status: urine reagent strips (URS) and a urine color (Ucol) chart to a refractometer. Setting: We utilized the athletic training room of a Division I-A collegiate American football team. Participants: Trial 1 involved urine samples of 69 veteran football players (age=20.1+1.2yr; body mass=229.7+44.4lb; height=72.2+2.1in). Trial 2 involved samples from 5 football players (age=20.4+0.5yr; body mass=261.4+39.2lb; height=72.3+2.3in). Interventions: We administered the Heat Illness Index Score (HIIS) Risk Assessment, to identify athletes at-risk for EHI (Trial 1). For individuals “at-risk” (Trial 2), we collected urine samples before and after 15 days of pre-season “two-a-day” practices in a hot, humid environment(mean on-field WBGT=28.84+2.36oC). Main Outcome Measures: Urine samples were immediately analyzed for Usg using a refractometer, Diascreen 7® (URS1), Multistix® (URS2), and Chemstrip10® (URS3). Ucol was measured using Ucol chart. We calculated descriptive statistics for all main measures; Pearson correlations to assess relationships between the refractometer, each URS, and Ucol, and transformed Ucol data to Z-scores for comparison to the refractometer. Results: In Trial 1, we found a moderate relationship (r=0.491, p<.01) between URS1 (1.020+0.006μg) and the refractometer (1.026+0.010μg). In Trial 2, we found marked relationships for Ucol (5.6+1.6shades, r=0.619, p<0.01), URS2 (1.019+0.008μg, r=0.712, p<0.01), and URS3 (1.022+0.007μg, r=0.689, p<0.01) compared to the refractometer (1.028+0.008μg). Conclusions: Our findings suggest that URS were inconsistent between manufacturers, suggesting practitioners use the clinical refractometer to accurately determine Usg and monitor hydration status.