Submission date
11/02/2024
Registration date
08/03/2024
Last edited
18/03/2024
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Not Applicable
Retrospectively registered
Protocol added
? SAP not yet added
Results not yet expected
Raw data not yet expected
Record updated in last year

Plain English Summary

Background and study aims
Adverse childhood experiences in childhood have been found to have a strong association with a range of health behaviours and outcomes, including early onset of alcohol use, binge drinking, illicit drug use, depression, low life satisfaction, unintended teenage pregnancy and premature death. There is also evidence of a relationship between adverse childhood experiences and future violent behaviour, both as a victim and perpetrator. In Wales, those who have experienced four or more adverse childhood experiences were found to be 15 times more likely to have been the perpetrator of a violent incident. A study of almost 12,000 young offenders found that, on average, exposure to each additional adverse childhood experience increased the risk of becoming a serious, violent, or chronic young offender by 35%. The trauma-informed practice aims to address the consequences of adverse childhood experiences by changing the relationship between practitioners and participants and addressing stigma to create a safe environment for young people to express their emotions and understand the relationship between their emotions and behaviour. This safe environment allows those who experienced trauma to see adults in a more positive light and aims to reduce the impact of adverse childhood experiences on future behaviour.

Relationship Building Together is a psychology-based, trauma-informed means of working with young people with complex needs who are suspected of or known to have experienced trauma. Delinquent behaviour and offending are seen as responses to trauma and the model aims to build relationships with young people that are sensitive, empathetic, and non-punitive. The key aim is to ensure that any professional interactions and interventions are designed to align with the young person’s developmental and mental health needs. Creating positive experiences and strong trusting relationships between young people and professionals are key components in ensuring young people are capable and willing to engage in supportive intervention and take advantage of positive opportunities to not only reduce delinquent behaviour but also improve across a spectrum of psychosocial domains. The type of interventions delivered and their duration are dependent on the needs of the young person, and these needs are assessed at the outset by a trauma-informed specialist with input from a clinical psychologist.

Who can participate?
Children and young people aged from 10 to 21 years old who are referrals to the participating services

What does the study involve?
The study is taking place across all young services in Bridgend County Borough Council who work with young people, Edge of Care, Early Help, Youth Development, and Youth Justice. Participants have an equal opportunity to receive the Relationship Building Together intervention or business as usual, the decision about what they receive will be made at random and will be followed up 6 and 12 months after recruitment.

What are the possible benefits and risks of participating?
The benefits of participating include contributing to an understanding of how we might improve outcomes for young people and the potential to see reductions in offending behaviour, improved emotional regulation, and improved mental health and wellbeing. For those in the control group, any intervention they receive will be the same as they would have received in the absence of the study, so they will not be disadvantaged. The RBT approach has been delivered in other areas, but without a scientific evaluation, there is no evidence of any particular risk. It is acknowledged that any work that takes a trauma-informed perspective has the potential to create re-traumatisation, to address this all staff, including research staff, are trained in spotting the signs of re-traumatisation, and if it does occur, strategies are in place to ensure young people receive appropriate support from clinical psychology staff.

Where is the study run from?
Centre for Health Service Studies, University of Kent

When is the study starting and how long is it expected to run for?
October 2023 to February 2026

Who is funding the study?
1. Youth Endowment Fund
2. UK Home Office

Who is the main contact?
Professor Simon Coulton, s.coulton@kent.ac.uk

Study website

Contact information

Type

Public, Scientific, Principal Investigator

Contact name

Prof Simon Coulton

ORCID ID

http://orcid.org/0000-0002-7704-3274

Contact details

Centre for Health Service Studies
University of Kent
Canterbury
CT2 7NZ
United Kingdom
+44 (0)1227 820000
s.coulton@kent.ac.uk

Additional identifiers

EudraCT/CTIS number

Nil known

IRAS number

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Mixed method, two level, individually randomised controlled trial of a trauma informed intervention, Trauma Recovery Model Relationship Building Together, versus business as usual for adolescents and young adults served by Bridgend Youth Services

Acronym

Bridgend RBT

Study hypothesis

Relationship Building Together (RBT) approach is more efficacious at reducing offending compared with business as usual (BAU), measured using the Self Report Delinquency Scale (SRDS), over 6- and 12-months post-randomisation, in a population of young people, aged 10-21 years inclusive, accessing services provided by Bridgend Youth Offending Team, Bridgend Youth Development Services, Bridgend Early Help Hubs and Bridgend Edge of Care Services.

Ethics approval(s)

Approved 28/09/2023, Social Science Research Ethics University of Kent (Division for the Study of Law, Society and Social Justice, Canterbury, CT2 7RZ, United Kingdom; 44 b1227 824535; lssjethics@kent.ac.uk), ref: SCR0904

Study design

Single-centre interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Built environment/local authority, Community, Internet/virtual

Study type

Efficacy

Patient information sheet

See study outputs table

Condition

Reduction in offending behaviour in young people, aged 10-21 years, accessing services provided by Bridgend Borough Council Services.

Intervention

Intervention arm: Service provided by staff trained in trauma-informed Relationship Building Together (RBT) approach.
Control arm: Business as usual.
No limit on the intensity or duration of treatment in either arm.
Staff are allocated to be trained in the RBT approach or business as usual using minimisation to maintain balance in terms of service (Edge of Care, Early Help, Youth Development, Youth Justice) and role speciality (specialist, generic).
Eligible and consenting young people are allocated using a secure remote randomisation service independent of the research team using block randomisation and stratified by service (Edge of Care, Early Help, Youth Development, Youth Justice), age group (<15 years, >=15 years) and sex (male, female).

As stated, there is no limit or duration to the intervention offered in either arm, the interventions that may be one or multiple, delivered in multiple settings by different agencies are based on a case formulation. The main difference between the arms is that in the intervention arm, staff trained in RBT will conduct a case formulation that takes a trauma-informed perspective, this includes taking a developmental timeline to establish the developmental age of the young person and an exploration of prior trauma. Both will enable the staff member to conduct a case formulation that aims to address the role of trauma in the child’s behaviour. In addition, staff trained in RBT will have access to a clinical psychologist to provide support in the choice of intervention delivered.

Intervention type

Behavioural

Primary outcome measure

Offending behaviour measured using the Self-Report Delinquency Scale at baseline, 6- 12-months post randomisation.

Secondary outcome measures

The following Secondary outcome measures are assessed at baseline, 6 and 12 months post randomisation:
1. Self-report behaviour and personality attributes (overall emotional and behavioural difficulties, emotional symptoms, conduct problems, hyperactivity, peer relationships, prosocial behaviour, externalising behaviours, internalising behaviours) measured using the Strengths and Difficulties Questionnaire (SDQ)
2. Self-report non-psychotic mental health measured using the General Health Questionnaire (GHQ12)
3. Self-report wellbeing measured using the Short Warwick Edinburgh Mental Wellbeing Scale (SWEMWBS)
4. Self-report family cohesion, expressiveness and conflict measured using the Brief Family Relationship Scale (BFRS)
5. Self-report police involvement (arrests, cautions, charges, court attendance) measured using the Client Service Receipt Inventory (CSRI)
6. Educational outcomes (suspensions, exclusions, managed moves) measured using the CSRI
7. Employment status measured using the CSRI

Overall study start date

01/10/2023

Overall study end date

28/02/2026

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 10-21 years old
2. Referred for assessment at participating service
3. Willing and able to provide informed consent

Participant type(s)

Service user

Age group

Mixed

Lower age limit

10 Years

Upper age limit

21 Years

Sex

Both

Target number of participants

562

Participant exclusion criteria

Not meeting the inclusion criteria

Recruitment start date

12/11/2023

Recruitment end date

28/02/2025

Locations

Countries of recruitment

United Kingdom, Wales

Study participating centre

Bridgend County Borough Council
Civic Offices, Angel St
Bridgend
CF31 4WB
United Kingdom

Sponsor information

Organisation

University of Kent

Sponsor details

The Registry
Canterbury
CT2 7NZ
England
United Kingdom
+44 (0)1227 820000
t.coleman-581@kent.ac.uk

Sponsor type

University/education

Website

https://www.kent.ac.uk/research-innovation-services/research-ethics-and-governance

ROR

https://ror.org/00xkeyj56

Funders

Funder type

Charity

Funder name

Youth Endowment Fund

Alternative name(s)

YouthEndowFund, YEF

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

Location

United Kingdom

Funder name

Home Office

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Key publications include reports to the funder (Youth Endowment Fund), dissemination to key stakeholders (youth Justice Board and Local Authorities), dissemination to target population (Young people and Families), publication in high impact peer-reviewed journals.

Intention to publish date

30/12/2026

Individual participant data (IPD) sharing plan

The datasets generated during and/or analysed during the current study will be stored in a publicly available repository.

Anonymised data will be transferred to the YEF data archive with access controlled by the Office of National Statistics https://youthendowmentfund.org.uk/evaluation-data-archive/.

IPD sharing plan summary

Stored in publicly available repository

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet 14/02/2024 No Yes
Participant information sheet 14/02/2024 No Yes
Protocol article 23/01/2024 14/02/2024 Yes No

Editorial Notes

18/03/2024: Internal review. 12/02/2024: Study's existence confirmed by the Social Science Research Ethics of the University of Kent.