RESUMEN
BACKGROUND: Youth with serious mental illness may experience improved psychiatric stability with second generation antipsychotic (SGA) medication treatment, but unfortunately may also experience unhealthy weight gain adverse events. Research on weight loss strategies for youth who require ongoing antipsychotic treatment is quite limited. The purpose of this paper is to present the design, methods, and rationale of the Improving Metabolic Parameters in Antipsychotic Child Treatment (IMPACT) study, a federally funded, randomized trial comparing two pharmacologic strategies against a control condition to manage SGA-related weight gain. METHODS: The design and methodology considerations of the IMPACT trial are described and embedded in a description of health risks associated with antipsychotic-related weight gain and the limitations of currently available research. RESULTS: The IMPACT study is a 4-site, six month, randomized, open-label, clinical trial of overweight/obese youth ages 8-19 years with pediatric schizophrenia-spectrum and bipolar-spectrum disorders, psychotic or non-psychotic major depressive disorder, or irritability associated with autistic disorder. Youth who have experienced clinically significant weight gain during antipsychotic treatment in the past 3 years are randomized to either (1) switch antipsychotic plus healthy lifestyle education (HLE); (2) add metformin plus HLE; or (3) HLE with no medication change. The primary aim is to compare weight change (body mass index z-scores) for each pharmacologic intervention with the control condition. Key secondary assessments include percentage body fat, insulin resistance, lipid profile, psychiatric symptom stability (monitored independently by the pharmacotherapist and a blinded evaluator), and all-cause and specific cause discontinuation. This study is ongoing, and the targeted sample size is 132 youth. CONCLUSION: Antipsychotic-related weight gain is an important public health issue for youth requiring ongoing antipsychotic treatment to maintain psychiatric stability. The IMPACT study provides a model for pediatric research on adverse event management using state-of-the art methods. The results of this study will provide needed data on risks and benefits of two pharmacologic interventions that are already being used in pediatric clinical settings but that have not yet been compared directly in randomized trials. TRIAL REGISTRATION: Clinical Trials.gov NCT00806234.
RESUMEN
PURPOSE: This study investigated the feasibility and efficacy of a working memory training program for improving memory and language skills in a sample of 9 children who are deaf (age 7-15 years) with cochlear implants (CIs). METHOD: All children completed the Cogmed Working Memory Training program on a home computer over a 5-week period. Feasibility and acceptability of the program were evaluated using parent report and measures of children's performance on the training exercises. Efficacy measures of working memory and sentence repetition were obtained prior to training, immediately after training, and 1 month and 6 months after training. RESULTS: Children's performance improved on most training exercises, and parents reported no problems with children's hearing or understanding of the exercises. After completion of working memory training, children demonstrated significant improvement on measures of verbal and nonverbal working memory, parent-reported working memory behavior, and sentence-repetition skills. The magnitude of improvement in working memory decreased slightly at the 1-month follow-up and more substantially at 6-month follow-up. However, sentence repetition continued to show marked improvement at 6-month follow-up. CONCLUSIONS: Working memory training may produce benefit for some memory and language skills for children with CIs, supporting the importance of conducting a large-scale, randomized clinical trial with this population.