David J Miklowitz1, Jean M Addington2, Mary P O'Brien3, Danielle M Denenny1, Marc J Weintraub1, Jamie L Zinberg1, Daniel H Mathalon4, Barbara A Cornblatt5, Michelle S Friedman-Yakoobian6, William S Stone7, Kristin S Cadenhead8, Scott W Woods9, Catherine A Sugar1,10, Tyrone D Cannon3, Carrie E Bearden1. 1. Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuropsychiatry and Behavior, University of California, Los Angeles, California, USA. 2. Department of Psychiatry, University of Calgary, Calgary, Canada. 3. Department of Psychology, Yale University, New Haven, Connecticut, USA. 4. Department of Psychiatry and Behavioral Sciences, University of California, San Francisco, California, USA. 5. Division of Psychiatry Research, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, USA. 6. Department of Public Psychiatry Massachusetts Mental Health Center, Harvard Medical School at Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA. 7. Department of Psychiatry, Harvard Medical School at Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA. 8. Department of Psychiatry, University of California, San Diego, La Jolla, California, USA. 9. Department of Psychiatry, Yale University, New Haven, Connecticut, USA. 10. Department of Biostatistics, UCLA Fielding School of Public Health, Los Angeles, California, USA.
Abstract
AIMS: Young people with attenuated psychotic symptoms (APS), brief intermittent psychosis, and/or genetic risk and functional deterioration are at high risk for developing psychotic disorders. In a prior trial, family-focused therapy for clinical high risk youth (FFT-CHR) was more effective than brief psychoeducation in reducing APS severity over 6 months. This 7-site trial will compare the efficacy of FFT-CHR to a psychoeducational and supportive intervention (enhanced care) on APS and social functioning in CHR individuals over 18 months. METHODS: Participants (N = 220, ages 13-25 years) with a CHR syndrome will be randomly assigned to FFT-CHR (18 1-h sessions of family psychoeducation and communication/problem-solving skills training) or enhanced care (3 1-h family psychoeducational sessions followed by 5 individual support sessions), both given over 6 months. Participants will rate their weekly progress during treatment using a mobile-enhanced online platform. Family communication will be assessed in a laboratory interactional task at baseline and post-treatment. Independent evaluators will assess APS (primary outcome) and psychosocial functioning (secondary outcome) every 6 months over 18 months. RESULTS: We hypothesize that, compared to enhanced care, FFT-CHR will be associated with greater improvements in APS and psychosocial functioning over 18 months. Secondarily, improvements in family communication over 6 months will mediate the relationship between treatment condition and primary and secondary outcomes over 18 months. The effects of FFT-CHR are predicted to be greater in individuals with higher baseline risk for psychosis conversion. CONCLUSIONS: Results of the trial will inform treatment guidelines for individuals at high risk for psychosis.
AIMS: Young people with attenuated psychotic symptoms (APS), brief intermittent psychosis, and/or genetic risk and functional deterioration are at high risk for developing psychotic disorders. In a prior trial, family-focused therapy for clinical high risk youth (FFT-CHR) was more effective than brief psychoeducation in reducing APS severity over 6 months. This 7-site trial will compare the efficacy of FFT-CHR to a psychoeducational and supportive intervention (enhanced care) on APS and social functioning in CHR individuals over 18 months. METHODS: Participants (N = 220, ages 13-25 years) with a CHR syndrome will be randomly assigned to FFT-CHR (18 1-h sessions of family psychoeducation and communication/problem-solving skills training) or enhanced care (3 1-h family psychoeducational sessions followed by 5 individual support sessions), both given over 6 months. Participants will rate their weekly progress during treatment using a mobile-enhanced online platform. Family communication will be assessed in a laboratory interactional task at baseline and post-treatment. Independent evaluators will assess APS (primary outcome) and psychosocial functioning (secondary outcome) every 6 months over 18 months. RESULTS: We hypothesize that, compared to enhanced care, FFT-CHR will be associated with greater improvements in APS and psychosocial functioning over 18 months. Secondarily, improvements in family communication over 6 months will mediate the relationship between treatment condition and primary and secondary outcomes over 18 months. The effects of FFT-CHR are predicted to be greater in individuals with higher baseline risk for psychosis conversion. CONCLUSIONS: Results of the trial will inform treatment guidelines for individuals at high risk for psychosis.
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