Condition category
Mental and Behavioural Disorders
Date applied
16/02/2009
Date assigned
09/03/2009
Last edited
06/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Peter Fonagy

ORCID ID

Contact details

UCL Psychoanalysis Unit
Research Department of Clinical
Educational and Health Psychology
1-19 Torrington Place
London
WC1E 6BT
United Kingdom
+44 (0)20 76791943
p.fonagy@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

START (Systemic Therapy for At Risk Teens): a national randomised controlled trial to evaluate multisystemic therapy for young people at risk of out of home placement as a result of antisocial behaviour in the UK context

Acronym

START

Study hypothesis

We aim to carry out a pragmatic trial that will inform policy makers, commissioners of services and professionals about the potential of Multisystemic Therapy (MST) in a UK context, investigating whether the provision of MST could reduce the incidence of out of home placements for young people at risk of being removed from their homes because of antisocial behaviour, mental health problems, educational problems or unmet need. The trial will take referrals of families with an adolescent with antisocial behaviour problems who is considered to be at risk of custodial or other forms of out of home care. The trial will answer the question of whether MST can contribute to significantly reducing the rate of out of home placement.

Ethics approval

To be submitted as of 16/02/2009.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Mental health problems and antisocial behaviour in adolescents

Intervention

Multi-systemic therapy is an integrative, manualised, licensed programme with a substantial evidence base for engaging young people exhibiting anti-social behaviour and their families. Adolescents with severe conduct problems will be treated over a period of 3-6 months with a community-based multi-component treatment programme focused on the family but also engaging schools, neighbourhoods and community resources and administered by specifically trained professionals with relatively low caseloads. The frequency of contact with the MST workers will be monitored but not controlled. It is expected that, as with MAU, some families will require briefer periods of treatment or may prematurely terminate treatment unilaterally. MST will be delivered by a team of at least 3 specially trained clinicians under the supervision of an MST supervisor, with weekly one hour conference calls for consultation with an MST services staff member. In addition, it is expected that MST therapists will have the support of local consultation from mental health professionals with post-graduate qualifications in disciplines such as social work, psychology or counselling.

Control group: Usual care only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Proportion of cases assigned to long-term (3 months+) out of home placements in specialist residential provision at 18 months following randomisation including placement into local authority care, incarceration, long-term hospitalisation and residential schooling.

Secondary outcome measures

1. Forensic outcomes at 18 months
2. Adolescent wellbeing outcomes at 18 months
3. Family functioning outcomes at 18 months
4. Cost of MST relative to management as usual, and the cost-effectiveness of providing this intensive form of intervention against the background of costs incurred at 18 months

Overall trial start date

01/03/2009

Overall trial end date

01/03/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Candidates (both males and females) will be referred if they meet 3 of the following features indicative of 'risk status':
1. Excluded or at significant risk of school exclusion
2. High levels of non attendance at school
3. An offending history or at significant risk of offending
4. Previous episodes on the Child Protection Register
5. Previous episodes of being looked after
6. Previous referral to Family Group Conference (FGC) to prevent young person from becoming looked after
7. History of siblings being looked after

Referrals considered suitable by the panel will be included in the trial if they meet the following general inclusion criteria:
1. Young person aged 11-17 years
2. Sufficient family involvement for MST to be applied, excluding adolescents already in local authority care or foster accommodation
3. No existing agency involvement (e.g., the family is already engaged with a therapist) which would interfere with MST
4. Meets ONE of the following set of criteria indicating suitability for MST:
4.1. Persistent (weekly) and enduring (6 months or longer) violent and aggressive interpersonal behaviour OR
4.2. A significant risk of harm to self or to others OR
4.3. At least one conviction and three warnings, reprimands or convictions in the last 18 months OR
4.4. Current diagnosis of externalising disorder and a record of unsuccessful outpatient treatment OR
4.5. Permanent school exclusion

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

700

Participant exclusion criteria

1. History or current diagnosis of psychosis
2. Generalised learning problems (clinical diagnosis) as indicated by IQ below 65
3. Risk of injury or harm to a worker
4. Presenting issues for which MST has not been empirically validated

Recruitment start date

01/03/2009

Recruitment end date

01/03/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UCL Psychoanalysis Unit
London
WC1E 6BT
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom
stephen.butler@ucl.ac.uk

Sponsor type

University/education

Website

http://www.ucl.ac.uk/

Funders

Funder type

Government

Funder name

Department for Children, Schools and Families in conjunction with the Department of Health (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23962220

Publication citations

  1. Protocol

    Fonagy P, Butler S, Goodyer I, Cottrell D, Scott S, Pilling S, Eisler I, Fuggle P, Kraam A, Byford S, Wason J, Haley R, Evaluation of multisystemic therapy pilot services in the Systemic Therapy for At Risk Teens (START) trial: study protocol for a randomised controlled trial., Trials, 2013, 14, 265, doi: 10.1186/1745-6215-14-265.

Additional files

Editorial Notes