A study to explore whether a multi-component psychosocial intervention can reduce substance use in adolescents who are involved in the criminal justice system in the UK
| ISRCTN | ISRCTN77037777 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77037777 |
| Protocol serial number | 1.0 |
| Sponsor | University of Kent |
| Funder | National Institute for Health Research |
- Submission date
- 04/09/2016
- Registration date
- 14/09/2016
- Last edited
- 31/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
There is a body of research that provides clear evidence that young people are more at risk of harm from substance use than adults. The developing brain is more susceptible to the effects of alcohol and drugs and adolescents are more likely to develop harmful and dependent drug use in a shorter time than adults. The impact of alcohol and drug use in adolescence can have lifelong implications, increasing the chances of experiencing physical and mental health issues and social problems. Young people who have committed an offence are far more likely to be using alcohol and drugs than other young people and there is clear evidence that their use of drugs is associated with their criminal activity. Many young offenders are managed in the community and there is evidence that these young people are more at risk of suffering negative consequences of drug and alcohol use. While the youth justice system routinely looks for signs of problematic drug use in this population access to treatment to address their use can be difficult and many of those in need do not receive any treatment. The RISKIT-CJS intervention was developed to address the underlying issues associated with adolescent risk-taking. The aim of this study is to find out whether the RISKIT-CJS intervention is more effective at reducing substance abuse than standard care.
Who can participate?
Young people aged between 13 and 17 who are engaged with a Youth Offending Team on a community order.
What does the study involve?
Participants are randomly allocated to one of two groups, where by one third take part in the RISKIT intervention and two thirds receive usual treatment. Those in group one receive treatment as usual for the duration of the study. Those in group two receive usual treatment as well as the RISKIT-CJS intervention. This is delivered over four sessions. The first session involves a face-to-face meeting to discuss substance use and risk taking behavior, to support behavior change and enhance motivation to change. The second session involves a four hour group session in which participants gain a better understanding of substance use and harms, triggers associated with substance use, minimizing risk, risk diversion and distraction, sexual health. The third session involves another four hour group session in which participants learn communication strategies, assertiveness training, anger management, mindfulness and future planning strategies. The final session is an hour-long individual session in which barriers to change, managing expectancy and enhancing self-efficacy are discussed. Participants in both groups complete a number of questionnaires at the start of the study and then again after six and 12 months to assess substance use and wellbeing.
What are the possible benefits and risks of participating?
Those who participate in the RISKIT programme are more likely to reduce their alcohol and drug use and manage their risk taking behaviour in a more appropriate ways leading to reductions in unprotected sex and criminal activity, all of which have implications for the future wellbeing of young people. There are no known risks involves with participating in this study.
Where is the study run from?
The study is run from the University of Kent with satellite co-ordination centres based at Kings College, London and University of Teesside, and takes place in Youth Offending Teams located in the South East, London and Greater London and North East of England (UK)
When is the study starting and how long is it expected to run for?
September 2016 to August 2019
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Prof. Simon Coulton
s.coulton@kent.ac.uk
Contact information
Scientific
Centre for Health Service Studies
University of Kent
Canterbury
Ct2 7NZ
United Kingdom
 ORCID ID |
0000-0002-7704-3274 |
|---|---|
| Phone | +44 1227 824535 |
| s.coulton@kent.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-centre individually randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | RISKIT-CJS: Pragmatic randomized controlled trial to evaluate the effectiveness and cost-effectiveness of a multi-component intervention to reduce substance use and risk-taking behaviour in adolescents involved in the criminal justice system |
| Study acronym | RISKIT CJS |
| Study objectives | Primary null hypothesis: The RISKIT CJS intervention is no more effective than treatment as usual in reducing the frequency of substance use 12 months after randomisation as measured using the Time Line Follow Back 28. Secondary null hypotheses: 1. The RISKIT CJS intervention is no more cost-effective than treatment as usual over 12 months after randomisation 2. The RISKIT CJS intervention is no more effective than treatment as usual in increasing mental health wellbeing 12 months after randomisation as measured Warwick Edinburgh Mental Wellbeing Scale 3. The RISKIT CJS intervention is no more effective than treatment as usual in reducing criminal justice recidivism in the 12 months after randomisation |
| Ethics approval(s) | Ethics was approved by University of Kent Social Research Ethics Committee, 12/12/2016, ref SRCEA169 |
| Health condition(s) or problem(s) studied | Adolescent substance use |
| Intervention | Participants are randomised to one of two groups using a secure independent randomization service and occurs after completion of the baseline battery. Randomisation employs blocks of unequal size stratified by centre. It is unequal in order to ensure twice as many participants receive the control versus the intervention. Control condition: Participants receive treatment as usual as provided by the current provider, there is no limit on the intervention or duration of treatment. RISKIT-CJS intervention: Participants receive treatment as usual augmented with the RISKIT-CJS intervention. RISKIT-CJS is delivered over 4 sessions. Session 1 is an individual face to face session with a trained interventionist lasting 45 minutes; to discuss substance use and risk taking behavior, to support behavior change and enhance motivation to change. Session 2 is a group intervention over a 4-hour period involving both psycho-education and skills development including; understanding substance use and harms, triggers associated with substance use, minimizing risk, risk diversion and distraction, sexual health. Session 3 is a group intervention over 4 hours and involves; communication strategies, assertiveness training, anger management, mindfulness, future planning strategies. Session 4 is an individual face to face session addressing barriers to change, managing expectancy and enhancing self-efficacy delivered over 60 minutes. All participants are followed up at 6 and 12 months after randomization. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Percent days abstinent from substance use in the 28-days prior to the 12-month follow-up is measured using the Time-Line Follow Back 28 (TLFB28) method 12 months after randomization. |
| Key secondary outcome measure(s) |
1. Quantity and type of substances consumed, sexual activity (planned, unplanned and regretted) and incidences of self-harming behaviour in the 28 days prior to the 6 and 12-month follow-up derived from the Time Line Follow-up (TLFB28) method at baseline, 6 and 12 months |
| Completion date | 31/08/2019 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Child |
| Lower age limit | 13 Years |
| Upper age limit | 17 Years |
| Sex | All |
| Target sample size at registration | 567 |
| Total final enrolment | 693 |
| Key inclusion criteria | 1. Aged between 13 and 17 years inclusive 2. Involved with Youth Offending Team on a community order 3. Score of 2 or more on the substance use domain of the ASSET risk profile 4. Willing and able to provide informed consent |
| Key exclusion criteria | 1. Severity of substance use requiring immediate referral for clinical intervention for detoxification. 2. Criminal justice involvement that is likely to lead to incarceration within the follow-up period. 3. Currently on an order that requires substance use abstinence. |
| Date of first enrolment | 01/03/2017 |
| Date of final enrolment | 28/02/2018 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
CT2 7NZ
United Kingdom
Tees Valley
Middlesbrough
TS1 3BX
United Kingdom
London
SE5 8BB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in repository |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2023 | 31/05/2023 | Yes | No |
| Protocol article | protocol | 11/03/2017 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
31/05/2023: Publication reference and total final enrolment added.
04/09/2017: Ethics approval information has been added.
14/03/2017: Publication reference added.
