Not All Masks Are Created Equal: Masking Success in Clinical Trials of Children and Adolescents

The current study assessed the success of masking omega-3 (Ω3) and psychotherapy in clinical trials of youth with depression or bipolar spectrum disorder. Participants were youth ages 7–14 with DSM-IV-TR diagnosed depressive (n = 72) or bipolar spectrum (n = 23) disorders. Inclusion diagnoses were depressive disorder, cyclothymic disorder, or bipolar disorder not otherwise specified. Exclusion diagnoses included bipolar I or II disorder, chronic medical condition or autism. Youth participated in 2 × 2 randomized controlled trials, in which they received Ω3 or placebo (PBO) and psychoeducational psychotherapy (PEP) or active monitoring (AM). Participants and study staff (including independent interviewers) were masked to Ω3/PBO allocation. Besides the masked independent interviewers, one coprincipal investigator (Co-PI) was fully masked to both conditions and completed all consensus conference ratings postrandomization. At the endpoint assessment or last completed interview, interviewers and the masked Co-PI guessed whether each child was assigned to Ω3 or PBO and to PEP or AM. Masking failure was calculated using the degree of correct guesses above chance level using binomial tests across all participants for Ω3 versus PBO and PEP versus AM. For all guessers, Ω3 allocation was guessed correctly approximately half the time (50%–52.5%). Rates of correct guessing were higher for PEP, but only the interviewer guesses were correct significantly more often (58.5%–68.7%) than chance. Reporting of masking success should be an essential element of RCTs. Psychotherapy is generally more difficult to mask, but with attentive masking procedures reasonable masking can be achieved.     

Factor Structure and Sensitivity to Change of the Recovery Assessment Scale

The focus on recovery, not just symptom reduction, in mental health care brings a need for psychometrically sound measures of recovery. This study examined the factor structure and sensitivity to change of a common measure of mental health recovery, the Recovery Assessment Scale (RAS). We conducted a secondary data analysis from a randomized clinical trial of self-management for depression (n = 302). We tested both bifactor and the previously found five-factor model. Sensitivity to change was examined three ways: (1) between the intervention and control group; (2) across time in the intervention group; and (3) in those whose depression remitted. The previous five-factor model was supported. One subscale, no domination by symptoms, was particularly sensitive to change and showed sensitivity to change whereas the subscale reliance on others did not show change in any of the comparisons. Results suggest that the subscales of the RAS should be examined separately in future studies of recovery.     

Motor control of velopharyngeal structures during vowel production

This investigation was designed to measure the ability of normal adult speakers to exert voluntary control over velopharyngeal positioning. Speakers were asked to phonate the vowels [a] and [i] at 50 percent and 75 percent of complete velopharyngeal closure, using visual feedback of velopharyngeal opening and closing gestures from a phototransducer. The musculature of the velopharyngeal mechanism was hypothesized to act as a coordinated system that may demonstrate both motor flexibility and plasticity (Folkins, 1985) when forced to function in a novel way. Evidence of both motor system responses to a novel speaking condition was observed. Speakers were able either to phonate at intermediate closure levels without having to learn new motor rules, or to learn new rules for velopharyngeal muscle activation that resulted in the ability over time to position the velopharyngeal mechanism appropriately. As such, support is derived for the notion (Folkins, 1985) that speakers develop motor rules or coordinative structures involving the velopharyngeal mechanism that govern velopharyngeal movement. The characteristics of this coordinative structure framework has not yet been described, however, and are the subject of ongoing research efforts.