Condition category
Mental and Behavioural Disorders
Date applied
16/02/2009
Date assigned
09/03/2009
Last edited
08/05/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Youth antisocial behaviour is a common and serious problem with costly consequences to young people themselves, their families, and society in general. Antisocial behaviour is associated with higher rates of criminal behaviour, unstable relationships, unemployment, and mental health problems. Multisystemic Therapy (MST) is an intensive family and home-based intervention for young people with serious antisocial behaviour. Although the programme has had some positive outcomes in the U.S., its effectiveness has not yet been assessed in the UK. This study is made up of two parts. The purpose of the first part (START I) is to assess whether Multisystemic Therapy in the UK is more likely to reduce out of home placement compared to management as usual (MAU; i.e., whichever services they would have received in the absence of MST). The purpose of the second part (START II) is to assess whether MST is more likely to reduce criminal convictions compared to MAU.

Who can participate?
Young people who meet three of seven risk indicators, such as history of offending, poor school attendance, and previous episodes of being looked-after.

What does the study involve?
Families which are considered eligible for the study are invited to take part in the research. Each family is randomly allocated to a treatment programme: either MST, or MAU. Research assistants visit the family home with a questionnaire pack at baseline, 12, and 18 months, and (START I), and 24, 36 and 48 months (START II). The questionnaires take about 1-2 hours to complete. Families are also invited to take part in optional qualitative interviews, in which they are asked about their experiences with MST, and about their lives and well-being after taking part in the programme.

What are the possible benefits and risks of participating?
Families taking part in the study are reimbursed £25 per visit. No other direct benefits or risks are anticipated.

Where is the study run from?
The study is run by University College London and takes place in nine NHS sites providing MST services in England (UK)

When is the study starting and how long is it expected to run for?
January 2009 to September 2017

Who is funding the study?
Department for Children, Schools and Families in conjunction with the Department of Health (UK)

Who is the main contact?
Professor Peter Fonagy
p.fonagy@ucl.ac.uk

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

START I:
The aim of this study is 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.

START II:
The primary outcome of the study is to determine whether criminal conviction is reduced at 5-year follow-up in the MST arm compared to MAU.

Ethics approval

START I: South East Research Ethics Committee, 13/05/2009, ref: 09/H1102/55
Amendment to extend study to 5 years (START II): NRES Committee London – South East, 05/11/2013, ref: 09/H1102/55

Study design

START I: Randomised controlled trial
START II: Observational longitudinal cohort follow up study

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

START I:
MST is offered to families for a period of three to six months, depending on individual family needs. Treatments offered in the MAU arm are widely varied, depending on resources available within the local authority and individual family needs.

Once a referral has been accepted into the study, the research assistant visits the family to confirm participation and complete consent forms. An independent statistician then manages the randomisation and the MST team administrator contacts the Trial Coordinator to find out the results of the randomisation. If the family has been allocated to MAU, the MST supervisor alerts the multi-agency panel for treatment allocation.

MST: 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 (violence, drug abuse, school expulsion) are 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. Adolescents and their families receive a minimum of 3 and a maximum of 6 months of input from the MST team; it is expected that some families will require briefer periods of treatment or may prematurely terminate treatment unilaterally. MST is 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, MST therapists have the support of local consultation from mental health professionals with post-graduate qualifications in disciplines such as social work, psychology or counselling.

MAU: Management As Usual is the standard care offered to adolescents and their families who meet eligibility criteria for the trial. This treatment is likely to be diverse and may involve no therapeutic intervention or individual or family orientated work. It is likely to be delivered by a wide range of practitioners with quite different theoretical orientations. The average duration of these interventions is also likely to vary. It is expected that practitioners will be working in line with best practice as specified in relevant SCIE and NICE guidance. MAU interventions are carefully monitored using a service use schedule designed specifically for the trial that will record contact with all services (health, social, YOT, education, voluntary sector etc), including number of contacts (and possibly average duration of contacts). As this is a pragmatic trial involving a number of collaborating services even within each site, it is not possible to specify in advance what management as usual will be.

Families are followed up to 24 months in START I.

START II:
The study involves the 684 families (young people and parents/carers) recruited into the START I trial. All participants were initially sent an opt-out letter, giving them information on how they could opt-out of being contacted by the research team about START II. If the family does not opt out, the research team contacts the family to discuss continued participation in the trial. If the family agrees to take part, they are given an updated information sheet, and asked to sign an updated consent form, explaining the extension of the study to 60 months. Participants are then invited to take part in yearly follow-up assessments at 24, 36, and 48 months post randomisation. At each follow-up point, the family is contacted by the research assistant (RA) who schedules a time to visit the family in person. Both the young person and the parent separately complete the questionnaire pack with the assistance of the RA. The questionnaire pack takes approximately 2-3 hours to complete and includes assessments of emotional well-being, mental health, education and work adjustment, physical health, demographic data, antisocial behaviour (e.g., arrests, convictions), family cohesion and parenting. Parents and young people receive £12.50 each for taking part.

Primary outcome data (offending) continues to be collected up to 60 months post randomisation, unless the family does not give consent for this.

Additionally, all families are invited to take part in a qualitative component of the study, comprised of semi-structured interviews with young people and parents about their experiences with MST, their outcomes in terms of offending, emotional well-being, relationships with family and peers, and their outlook on the future. The interviews will be analysed for themes using Framework analysis.

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 (START I) and 5 years post randomisation (START II) including placement into local authority care, incarceration, long-term hospitalisation and residential schooling.

Secondary outcome measures

START I:
1. Criminal activity is measured by CA-SUS: last 2 questions on Criminal Justice Service to be completed separately from the Parent at baseline, 12, 18, 24, 36 and 48 months
2. Mood and feelings is measured by Short Mood and Feelings at baseline, 12, 18, 24, 36 and 48 months
3. Callous/unemotional traits is measured by Inventory of Callous and Unemotional Traits (ICU) at baseline, 12, 18, 24, 36 and 48 months
4. Conduct problems is measured by Study of Parents’ and Children’s Experience (SRD) at baseline, 12, 18, 24, 36 and 48 months
5. Levels of Expressed Emotions is measured by Levels of Expressed Emotions (LEE) at baseline, 12, 18, 24, 36 and 48 months.
6. Intelligence is measured by Wechsler Abbreviated Scale of Intelligence (WASI III)- Vocabulary and Matrix Reasoning subtests at baseline, 12, 18, 24, 36 and 48 months
7. Antisocial Beliefs and Attitudes is measured by Antisocial Beliefs and Attitudes Scales (ABAS) and Social Desirability Questions (Jessness Lie Scale) at baseline, 12, 18, 24, 36 and 48 months
8. Behavioural problems is measured by Strengths and Difficulties (SDQ) and DAWBA (on the computer) at baseline, 12, 18, 24, 36 and 48 months
9. Parenting style is measured by Alabama Parenting (APQ) at baseline, 12, 18, 24, 36 and 48 months
10. Materialism is measured by Youth Materialism Scale at baseline, 12, 18, 24, 36 and 48 months
11. Health status is measured by EQ-5D at baseline, 12, 18, 24, 36 and 48 months
12. Significant life events is measured by CLES- A- Life Events Questionnaire at baseline, 12, 18, 24, 36 and 48 months
13. Demographic information is measured by Demographic form- including work/ relationships at baseline, 12, 18, 24, 36 and 48 months
14. Quality of life is measured by SF-30 Health Survey at baseline, 12, 18, 24, 36 and 48 months
15. Psychological resilience is measured by Adolescence resilience questionnaire (ARQ) at baseline, 12, 18, 24, 36 and 48 months
16. Screening for affective disorders and schizophrenia is measured by Schedule for Affective Disorders and Schizophrenia (K-SADS) at baseline, 12, 18, 24, 36 and 48 months
17. Adaptive functioning and problems is measured by Adult self-report questionnaire at baseline, 12, 18, 24, 36 and 48 months.
18. Materialism is measured by Materialism at baseline, 12, 18, 24, 36 and 48 months
19. Screening for personality disorders is measured by Structured clinical Interview for DSM Disorders (SCID) at baseline, 12, 18, 24, 36 and 48 months
20. Service use and incurred expenses is measured by CA-SUS: to be completed with the young person apart from the final section, G, which asks the parent/carer about their out-of-pocket expenses and productivity losses at baseline, 12, 18, 24, 36 and 48 months
21. Demographic information is measured by Family Information Form (Part 1) at baseline, 12, 18, 24, 36 and 48 months
22. Screen for minor psychiatric disorders is measured by General Health Questionnaire (GHQ) at baseline, 12, 18, 24, 36 and 48 months
23. Callous/unemotional traits is measured by Inventory of Callous and Unemotional Traits (ICU) at baseline, 12, 18, 24, 36 and 48 months
24. ADHD is measured by Conner’s Parent Rating Scale at baseline, 12, 18, 24, 36 and 48 months
25. Behavioural problems is measured by Strengths and Difficulties (SDQ) and DAWBA (on the computer) at baseline, 12, 18, 24, 36 and 48 months
26. Couple conflicts (parent and partner) is measured by Couple Conflicts (CTS2S) at baseline, 12, 18, 24, 36 and 48 months
27. Parenting style is measured by Alabama Parenting (APQ) at baseline, 12, 18, 24, 36 and 48 months
28. Family adaptability and cohesion is measured by Family Adaptability and Cohesion Evaluation Scales (FACES-IV) at baseline, 12, 18, 24, 36 and 48 months
29. Demographic is measured by Family Information Questionnaire (Part II) at baseline, 12, 18, 24, 36 and 48 months
30. Parent supervision and involvement is measured by Loeber Caregiver Questionnaire at baseline, 12, 18, 24, 36 and 48 months
31. Behavioural and emotional problems is measured by Adult Behavior Check list (ABCL) at baseline, 12, 18, 24, 36 and 48 months
32. Screening for affective disorders and schizophrenia is measured by Schedule for Affective Disorders and Schizophrenia (K-SADS) at baseline, 12, 18, 24, 36 and 48 months
33. Behavioural problems (young person’s sibling) is measured by Sibling Strengths and Difficulties (SDQ) at baseline, 12, 18, 24, 36 and 48 months

START II:
The outcomes listed above are measured at 5 years.

Overall trial start date

01/01/2009

Overall trial end date

01/09/2017

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

01/09/2014

Recruitment end date

01/09/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London
Department of Clinical, Education, and Health Psychology 1-19 Torrington Place
London
WC1E 6BT
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom
+44 20 7679 2000 ext. 45985
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

The outcomes of START I are currently being prepared for publication in a peer-reviewed journal, with several subsidiary papers planned for publication afterwards.
There are currently no specific plans for dissemination of START II, but publication in a peer-reviewed journal is intended.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from p.fonagy@ucl.ac.uk

Intention to publish date

31/12/2017

Participant level data

Available on request

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

08/05/2017: The trial record has undergone a significant update to incorporate a longitudinal follow up (START II) which follows on from the main randomised controlled trial (START I). Changes to the record: 1. The outcome measures have been added 2. The interventions, hypothesis, study design, ethics approval and target number of participants for START II have been added 3. The overall study dates have been updated from 01/03/2009 - 01/03/2013 to 01/01/2009 - 01/09/2017 to encompass both parts of the study. The recruitment dates listed in the record are for START II, the recruitment dates for START I are 01/02/2010 - 01/09/2012. 4. The data sharing plan and publication and dissemination plan have been added 5. The plain English summary has been added