title: Youth Early-intervention Study (YES) - group interventions targeting social participation and physical well-being as an adjunct to treatment as usual: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  It is increasingly acknowledged that clinical interventions for young persons with mental disorders need to optimize social, vocational and physical functioning, and take into account developmental needs, rather than focusing only on the traditional target of psychiatric symptom change. However, few interventions for youth presenting to mental health services offer a coherent rationale for multi-faceted approaches that efficiently address all these targets. This trial uses two facilitated group therapy modules (social and physical activity) as a vehicle for promoting clinical, cognitive, social and vocational change. The modules are an adjunct to usual treatments offered to youth attending mental health services in Sydney, Australia.
  
  
  METHODS
  The design is a 2-arm, parallel group cross-over, randomized clinical trial (RCT) that examines the efficacy of this adjunctive youth early intervention program (called "YES") for improving social, vocational, mental and physical health functioning in a trans-diagnostic sample of 120 young persons aged 14-25 years who are currently receiving a range of "usual treatments" for clinically diagnosed anxiety, affective and/or psychotic disorders. Individuals who provide written informed consent are offered 2 group therapy modules (each comprising 4 hours per week for 8 weeks) with a 3-week "pause" between modules. Randomization determines whether individuals commence with module A or module B. The sample will be assessed pre-randomization, and at week 1 and week 8 (after completion of the first module), and at week 11 (commencement of second module) and week 19 (completion of second module). Final follow-up is 1-year post trial entry.
  
  
  CONCLUSIONS
  If the findings of this exploratory trial demonstrate benefits in the target domains, then it will be important to extend the research by undertaking: (a) a comparison of the YES program to a control intervention in a randomized controlled trial, (b) an explanatory study of putative mediators of change, and (c) a multi-center trial with a number of trained therapists offering the group modules combined with a longer follow-up period.
  
  
  BACKGROUND
  Australian New Zealand Controlled Trial Registration: ACTRN1262400175673 , Date: 16 July 2015.
authors.affiliation: Clinical Research Unit, Brain and Mind Research Institute, The University of Sydney, Sydney, NSW, Australia. gehue@icloud.com.
authors.forename: Lillian Jean
authors.initials: LJ
authors.lastname: Gehue
authors.affiliation: Clinical Research Unit, Brain and Mind Research Institute, The University of Sydney, Sydney, NSW, Australia. escott@sydney.edu.au.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Scott
authors.affiliation: Clinical Research Unit, Brain and Mind Research Institute, The University of Sydney, Sydney, NSW, Australia. dhermens@sydney.edu.au.
authors.forename: Daniel Francis
authors.initials: DF
authors.lastname: Hermens
authors.affiliation: Academic Psychiatry, Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK. jan.scott@newcastle.ac.uk.
authors.forename: Jan
authors.initials: J
authors.lastname: Scott
authors.affiliation: Clinical Research Unit, Brain and Mind Research Institute, The University of Sydney, Sydney, NSW, Australia. Ian.hickie@sydney.edu.au.
authors.forename: Ian
authors.initials: I
authors.lastname: Hickie
mesh_terms: D000293:Adolescent; D000294:Adolescent Behavior; D000328:Adult; D000367:Age Factors; D002985:Clinical Protocols; D018592:Cross-Over Studies; D061345:Early Medical Intervention / Q000379:methods*; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D001523:Mental Disorders / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D008603:Mental Health; D009043:Motor Activity; D009517:New South Wales; D011569:Psychiatric Status Rating Scales; D011615:Psychotherapy, Group / Q000379:methods*; D011788:Quality of Life; D012107:Research Design; D058992:Social Participation; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult