Evaluation of multisystemic therapy pilot services in the Systemic Therapy for At Risk Teens (START) trial: study protocol for a randomised controlled trial

TY - JOUR

T1 - Evaluation of multisystemic therapy pilot services in the Systemic Therapy for At Risk Teens (START) trial

T2 - study protocol for a randomised controlled trial

AU - Fonagy, Peter

AU - Butler, Stephen

AU - Goodyer, Ian

AU - Cottrell, David

AU - Scott, Stephen

AU - Pilling, Stephen

AU - Eisler, Ivan

AU - Fuggle, Peter

AU - Kraam, Abdullah

AU - Byford, Sarah

AU - Wason, James

AU - Haley, Rachel

PY - 2013/8/20

Y1 - 2013/8/20

N2 - Background: There is an urgent need for clinically effective and cost-effective methods to manage antisocial and criminal behaviour in adolescents. Youth conduct disorder is increasingly prevalent in the UK and is associated with a range of negative outcomes. Quantitative systematic reviews carried out for the National Institute for Health and Clinical Excellence have identified multisystemic therapy, an intensive, multimodal, home-based, family intervention for youth with serious antisocial behaviour, as one of the most promising interventions for reducing antisocial or offending behaviour and improving individual and family functioning. Previous international trials of multisystemic therapy have yielded mixed outcomes, and it is questionable to what extent positive US findings can be generalised to a wider UK mental health and juvenile justice context. This paper describes the protocol for the Systemic Therapy for At Risk Teens (START) trial, a multicentre UK-wide randomised controlled trial of multisystemic therapy in antisocial adolescents at high risk of out-of-home placement.Methods/Design: The trial is being conducted at 10 sites across the UK. Seven hundred participants and their families will be recruited and randomised on a 1: 1 basis to multisystemic therapy or management as usual. Treatments are offered over a period of 3 to 5 months, with follow-up to 18 months post-randomisation. The primary outcome is out-of-home placement at 18 months. Secondary outcomes include offending rates, total service and criminal justice sector costs, and participant well-being and educational outcomes. Data will be gathered from police computer records, the National Pupil Database, and interview and self-report measures administered to adolescents, parents and teachers. Outcomes will be analysed on an intention-to-treat basis, using a logistic regression with random effects for the primary outcome and Cox regressions and linear mixed-effects models for secondary outcomes depending on whether the outcome is time-to-event or continuous.Discussion: The START trial is a pragmatic national trial of sufficient size to evaluate multisystemic therapy, to inform policymakers, service commissioners, professionals, service users and their families about its potential in the UK. It will also provide data on the clinical and cost-effectiveness of usual services provided to youth with serious antisocial behaviour problems.

AB - Background: There is an urgent need for clinically effective and cost-effective methods to manage antisocial and criminal behaviour in adolescents. Youth conduct disorder is increasingly prevalent in the UK and is associated with a range of negative outcomes. Quantitative systematic reviews carried out for the National Institute for Health and Clinical Excellence have identified multisystemic therapy, an intensive, multimodal, home-based, family intervention for youth with serious antisocial behaviour, as one of the most promising interventions for reducing antisocial or offending behaviour and improving individual and family functioning. Previous international trials of multisystemic therapy have yielded mixed outcomes, and it is questionable to what extent positive US findings can be generalised to a wider UK mental health and juvenile justice context. This paper describes the protocol for the Systemic Therapy for At Risk Teens (START) trial, a multicentre UK-wide randomised controlled trial of multisystemic therapy in antisocial adolescents at high risk of out-of-home placement.Methods/Design: The trial is being conducted at 10 sites across the UK. Seven hundred participants and their families will be recruited and randomised on a 1: 1 basis to multisystemic therapy or management as usual. Treatments are offered over a period of 3 to 5 months, with follow-up to 18 months post-randomisation. The primary outcome is out-of-home placement at 18 months. Secondary outcomes include offending rates, total service and criminal justice sector costs, and participant well-being and educational outcomes. Data will be gathered from police computer records, the National Pupil Database, and interview and self-report measures administered to adolescents, parents and teachers. Outcomes will be analysed on an intention-to-treat basis, using a logistic regression with random effects for the primary outcome and Cox regressions and linear mixed-effects models for secondary outcomes depending on whether the outcome is time-to-event or continuous.Discussion: The START trial is a pragmatic national trial of sufficient size to evaluate multisystemic therapy, to inform policymakers, service commissioners, professionals, service users and their families about its potential in the UK. It will also provide data on the clinical and cost-effectiveness of usual services provided to youth with serious antisocial behaviour problems.

KW - Adolescent

KW - Antisocial behaviour

KW - Conduct disorder

KW - Family

KW - Multisystemic therapy

KW - Randomised controlled trial

KW - United Kingdom

KW - Youth

KW - CALLOUS-UNEMOTIONAL TRAITS

KW - ATTENTION-DEFICIT/HYPERACTIVITY DISORDER

KW - COMORBIDITY SURVEY REPLICATION

KW - OPPOSITIONAL DEFIANT DISORDER

KW - SERIOUS JUVENILE-OFFENDERS

KW - CONDUCT DISORDER

KW - FOLLOW-UP

KW - YOUNG OFFENDERS

KW - MENTAL-HEALTH

KW - PSYCHOPATHIC TRAITS

U2 - 10.1186/1745-6215-14-265

DO - 10.1186/1745-6215-14-265

M3 - Article

SN - 1745-6215

VL - 14

JO - Trials

JF - Trials

M1 - 265

ER -