ISRCTN - ISRCTN28441235: Services for Teens Engaging in Problem Sexual Behaviour (STEPS-B)

Plain English Summary

Background and study aims
We want to learn which services are most effective for young people in the UK with problem sexual behaviour, and their families. Multisystemic Therapy for Youth with Problem Sexual Behaviours (MST-PSB) uses approaches from family therapy, parenting programmes, cognitive behavioural therapy and social skills building. The aim of this study is to find out whether MST-PSB is effective for young people who are at risk of being removed from their homes because of problematic sexual behaviour. The study will investigate whether MST-PSB reduces the levels of sexual and non-sexual offending, problem sexual behaviour and anti-social behaviour, leading to less time spent in custodial institutions, improved educational outcomes and improved family functioning.

Who can participate?
Families with an adolescent aged 10-17 who is at risk of out-of-home placement due to sexually related antisocial or delinquent behaviours, and/or young people involved with the youth justice system due to problem sexual behaviour.

What does the study involve?
Adolescents are randomly allocated to be treated with either MST-PSB or standard care as currently provided through the NHS. Treatments is offered over a period of about 5-7 months. Follow-up assessments are carried out 8, 14 and 20 months later.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
The study will be conducted by the research team based at University College London (UCL) from cases referred to the Brandon Centre (UK).

When is the study starting and how long is it expected to run for?
January 2012 to January 2015

Who is funding the study?
Department of Health (UK)

Who is the main contact?
The research team at University College London
steps-b@ucl.ac.uk

Trial website

http://www.ucl.ac.uk/steps-b/

Contact information

Type

Scientific

Primary contact

Ms Rachel Haley

ORCID ID

Contact details

Department of Clinical
Educational and Health Psychology
University College London
1-19 Torrington Place
London
WC1E 7HB
United Kingdom
+44 (0)20 7679 5955
rachel.haley@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10567

Study information

Scientific title

A randomised controlled trial to evaluate multisystemic therapy for youth with problem sexual behaviours

Acronym

STEPS-B

Study hypothesis

We aim to carry out a pragmatic trial that will inform policy makers, commissioners of services and professionals about the potential of MST-PSB in the UK context, investigating whether the provision of MST-PSB could reduce the incidence of out of home placements for young people at risk of being removed from their homes primarily because of problematic sexual behaviour.

More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=10567

Ethics approval

South East Research Ethics Committee, 06/09/2011, ref: 11/LO/0772

Study design

Randomised interventional treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact steps-b@ucl.ac.uk to request a patient information sheet

Condition

Personality disorders

Intervention

Planned intervention:

Multisystemic Therapy for Youth with Problem Sexual Behaviours (MST-PSB) is a clinical adaptation of MST which builds upon the research and implementation base of standard MST to treat young people (and their families) for problematic sexual behaviour. The MST-PSB is an evidence-based practice developed to address the multiple determinants of problematic juvenile sexual behaviour in the context of the relative infancy of available treatment options and the paucity of outcome-related research supporting available treatments. Areas of Increased Focus in MST-PSB Adaptation include structural/strategic family therapy, safety planning, individual factors, and interventions specific to problem sexual behaviour (e.g., victim clarification, promotion of normative sexual behaviour).

Adolescents will be treated over a period of 5-7 months, the frequency of contact with the MST-PSB worked 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. In view of the breadth and complexity of this input, it will be essential to monitor consultation as well as contact time of the MST team in order to arrive at accurate assessments of health and social care costs.

MST-PSB is delivered in the community (clients' homes, schools, neighbourhoods) to ensure ecological validity and treatment generalization, occurs with a high level of intensity and frequency (often three or more sessions per week), incorporates treatment interventions that are strongly supported and informed by research, and places a high premium on approaching each client/family as unique.

The intervention procedure consists of regular visits to the family home to meet with the young person and/or parents for approximately one-hour. The number of visits is approximately 3 times per week at the beginning of the intervention and less as the intervention progresses. Overall, the intervention time is 5-7 months. If this specific intervention was given outside the research, the number of contacts would remain the same as it is based on the clinical needs of the family. The intervention is given by child mental health therapists specifically trained and supervised at each trial site by a clinical supervisor, supplemented by regular consultation with an MST consultant provided by MST Services. This quality assurance program is meant to ensure the therapists deliver high-quality interventions in line with the MST model. At all levels of supervision, attention to any risk issues that may arise with the young person are given priority.

Management as usual:

Interventions offered by the 5/6 Boroughs referring to the Brandon Centre will vary depending on locality and severity of the case. There will therefore be a number of potential options for management as usual. These will include individual CBT within a Youth Offending Service or a referral to CAMHS for CBT. Some CAMHs and YOTS offer a programme called AIM. Depending on the seriousness of the sexually harmful behavior the young person may be placed out of home and be expected to attend a specialist service including the Young Abusers Project run by NSPCC. Usually, in these settings the treatment of choice is either group or individual CBT or the young person may be placed in a residential setting such as SWAAY or the Bracton Centre. These settings offer a variety of individual and group programmes and attend to the young persons educational needs. Generally when making a recommendation in the pre sentence report the Youth Offending team social worker will recommend a community programme as an alternative to custody whereas if the referral pathway is via Safeguarding and Social Care and the offence has been committed in the home the disposal is more likely to be an out of home placement or placement in a residential setting.

Another option available is The Portman Clinic which is non residential and specialises in working with young people that have been convicted of a sexual offence. However its approach is individual therapy using a psychoanalytical model.

Follow-up assessments will be at 8, 14 and 20 months post-randomisation and data collected from families by the research team at UCL.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

1. Out of home placement
2. The proportion of cases assigned to long-term (3 months+) out of home placement in specialist reside

Secondary outcome measures

No secondary outcome measures

Overall trial start date

03/01/2012

Overall trial end date

31/01/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Young people aged 10-17 years old
2. Sufficient family involvement for MST-PSB to be applied, living in the parental home, in long-term foster care or if they are in short-term out-of-home placement and family reunification is imminent (within 30-60 days)
3. No existing agency involvement (e.g. the family is already engaged with a therapist) which would interfere with MST-PSB
4. Problem sexual behaviour
5. Risk of custody or out-of-home placement
6. Risk of reoffending
7. Displaying aggression at home, at school or in the community
8. Male and female participants

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

UK Sample Size: 80

Participant exclusion criteria

1. Young person is living independently or a primary caregiver cannot be identified
2. Primary reason for referral is related to suicidal, homicidal, or psychotic behaviours
3. Young person has pervasive developmental delays young person has severe substance misuse as the primary presenting problem
4. Primary caregiver(s) denies that there is any possibility that the problem sexual behaviour occurred or that the youth was in any way responsible

Recruitment start date

03/01/2012

Recruitment end date

31/01/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London
London
WC1E 7HB
United Kingdom

Sponsor information

Organisation

University College London (UK)

Sponsor details

Department of Brain Repair and Rehabilitation
Gower Street
London
WC1E 6BT
United Kingdom