@article{1ebe4ca52d184f5e98d712b4aba29d53,
title = "Early intervention for youth at high risk for bipolar disorder: A multisite randomized trial of family-focused treatment",
abstract = "Aims: Despite the considerable public health impact of bipolar disorder (BD), no psychosocial interventions have been systematically evaluated in its early prodromal stages. We describe the rationale, design and analytic methods for a 3-site randomized trial of family-focused treatment for youth at high risk (FFT-HR) for BD. Methods: Participants (ages 9-17 years) have a diagnosis of unspecified BD or major depressive disorder, current mood symptoms and at least one first- or second-degree relative with a lifetime history of BD I or II. Participants are randomly assigned to FFT-HR (12 sessions in 4 months of family psychoeducation and skills training) or enhanced care (EC; 6 individual and family sessions over 4 months), with pharmacotherapy provided as needed. A subset of participants undergo pre- and post-treatment functional MRI (fMRI) scans while performing face-rating and family problem-solving tasks designed to activate corticolimbic circuitry. Independent evaluators assess participants{\textquoteright} status every 4 to 6 months for up to 4 years. Results: We hypothesize that FFT-HR will be more effective than EC in reducing the severity of mood symptoms (primary outcome) and the hazard of a first manic episode (secondary) over 4 years. Secondarily, we will explore whether FFT-HR is associated with greater decreases in amygdala activation and increases in dorsolateral, ventrolateral or anterior medial prefrontal cortex activation from pre- to post-treatment. Clinical characteristics of 133 subjects enrolled at baseline are described. Conclusions: This study will test a novel intervention to reduce the early symptoms of BD, and identify neural and behavioural mechanisms that may help refine future treatments.",
keywords = "expressed emotion, family therapy, mania, neuroimaging, prodromal",
author = "Miklowitz, {David J.} and Schneck, {Christopher D.} and Walshaw, {Patricia D.} and Garrett, {Amy S.} and Singh, {Manpreet K.} and Sugar, {Catherine A.} and Chang, {Kiki D.}",
note = "Funding Information: National Institute for Mental Health, Grant/ Award number: MH093666; Merck; GSK; Neuronetics; Janssen Pharmaceuticals; Stanford{\textquoteright}s Child Health Research Institute; Ryan White Foundation; Crown Family Foundation; Guilford Press; John Wiley and Sons; Max Grey Foundation; Danny Alberts Foundation; Attias Family Foundation; Knapp Family Foundation; Kayne Family Foundation; Carl and Roberta Deutsch Foundation; Brain and Behaviour Research Foundation; American Foundation of Suicide Prevention; National Institute of Mental Health (NIMH) grants collaborative R01, Grant/Award number: MH093676. Funding Information: This study was funded by National Institute of Mental Health (NIMH) collaborative R01 grants MH093676 (D.J.M.) and MH093666 (K.D.C.). D.J.M. has received research support from the NIMH, American Foundation of Suicide Prevention, Brain and Behaviour Research Foundation, Carl and Roberta Deutsch Foundation, Kayne Family Foundation, Knapp Family Foundation, Attias Family Foundation, Danny Alberts Foundation and Max Gray Foundation; and book royalties from John Wiley and Sons and Guilford Press. C.D.S. has received funding from the NIMH, Crown Family Foundation and Ryan White Foundation. P.D.W. reports no conflicts of interest. A.S.G. receives research funding from the NIMH. M.K.S. receives research funding from NIMH, the Brain and Behaviour Foundation, Stanford{\textquoteright}s Child Health Research Institute, and Janssen Pharmaceuticals and Neuronetics. C.A.S. has received research funding from NIMH. K.D.C. is an unpaid consultant for GSK, Lilly and BMS. He is on the Data Safety Monitoring Board for Sunovion. In the past 3 years, he has received research support from GSK and Merck, and has been a consultant for Actavis and Janssen pharmaceuticals. Funding Information: information National Institute for Mental Health, Grant/Award number: MH093666; Merck; GSK; Neuronetics; Janssen Pharmaceuticals; Stanford's Child Health Research Institute; Ryan White Foundation; Crown Family Foundation; Guilford Press; John Wiley and Sons; Max Grey Foundation; Danny Alberts Foundation; Attias Family Foundation; Knapp Family Foundation; Kayne Family Foundation; Carl and Roberta Deutsch Foundation; Brain and Behaviour Research Foundation; American Foundation of Suicide Prevention; National Institute of Mental Health (NIMH) grants collaborative R01, Grant/Award number: MH093676.This study was funded by National Institute of Mental Health (NIMH) collaborative R01 grants MH093676 (D.J.M.) and MH093666 (K.D.C.). D.J.M. has received research support from the NIMH, American Foundation of Suicide Prevention, Brain and Behaviour Research Foundation, Carl and Roberta Deutsch Foundation, Kayne Family Foundation, Knapp Family Foundation, Attias Family Foundation, Danny Alberts Foundation and Max Gray Foundation; and book royalties from John Wiley and Sons and Guilford Press. C.D.S. has received funding from the NIMH, Crown Family Foundation and Ryan White Foundation. P.D.W. reports no conflicts of interest. A.S.G. receives research funding from the NIMH. M.K.S. receives research funding from NIMH, the Brain and Behaviour Foundation, Stanford's Child Health Research Institute, and Janssen Pharmaceuticals and Neuronetics. C.A.S. has received research funding from NIMH. K.D.C. is an unpaid consultant for GSK, Lilly and BMS. He is on the Data Safety Monitoring Board for Sunovion. In the past 3 years, he has received research support from GSK and Merck, and has been a consultant for Actavis and Janssen pharmaceuticals. Publisher Copyright: {\textcopyright} 2017 John Wiley & Sons Australia, Ltd",
year = "2019",
month = apr,
doi = "10.1111/eip.12463",
language = "English (US)",
volume = "13",
pages = "208--216",
journal = "Early Intervention in Psychiatry",
issn = "1751-7885",
publisher = "Wiley-Blackwell",
number = "2",
}