Condition category
Mental and Behavioural Disorders
Date applied
28/05/2013
Date assigned
31/05/2013
Last edited
09/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We are conducting an adaptation of a family and social network intervention shown to be effective in helping adults experiencing alcohol and drug problems to be implemented with young people with alcohol and drug problems and tested in a small pilot study. Previous research has shown that the family has a considerable impact on young people’s drinking and drug use. Interventions involving the family and wider social networks have shown promise in helping young people to deal with substance abuse problems. At present there is limited delivery of family interventions for young people with alcohol and drug problems in routine practice in the UK. The study will adapt and further develop the Social Behaviour and Network Therapy (SBNT) approach that has been shown to be effective and cost-effective with adults with alcohol problems. This study will test feasibility of delivery and preliminary outcomes.

Who can participate?
We aim to recruit 60 young people (aged between 12 and 18) with drug and/or alcohol problems from specialist services.

What does the study involve?
Participants will be randomly allocated to receive the adapted SBNT approach or existing treatment as usual that is not family-focused. Half of those participating (N=30) will receive the adapted intervention and the remaining half treatment as usual. The family-based intervention will be adapted to support young people aged 12-18. Following consultation with young people who had experience of alcohol and drug problem services and their carers, we will adapt the family and social approach. The intervention will then be tested in a small pilot study in routine young people services in Birmingham and Newcastle. Once this intervention is adapted and produced in manual form, a selection of therapists delivering treatment for young people in those services will be trained and supervised to deliver this adapted treatment. The family and social intervention (SBNT) will consist of 6 meetings with the young person with the alcohol or drug problem and their close family members or friends that they wish to involve. Treatment as usual will consist of what is normally delivered in those services. Those receiving the intervention or the control treatment as usual will be assessed at the beginning of the study and 3 and 12 months later. The study will also measure other aspects that affect the young people, such as mental health, family factors, crime and the use of other services. The research team will assess whether the intervention reduces the use of these other services, and is therefore more cost-effective. The study will also help to inform a decision on whether to prepare for a larger study with more participants in the future.

What are the possible benefits and risks of participating?
If the intervention was shown to be successful, those receiving the adapted intervention will show some benefit. Those participants randomised to the treatment as usual will have an opportunity to receive the family intervention once the study is completed if they wish to do so. There should also be benefit for those young people receiving help for alcohol and drug problems in the future through the results informing practice. There are no anticipated risks of participating in this study.

Where is the study run from?
The study will be run from the School of Psychology, University of Birmingham and the Birmingham and Solihull Mental Health Trust.

When is the study starting and how long is it expected to run for?
This study will run from February 2014 to November 2015.

Who is funding the study?
The study is funded by the Health Technology Assessment (HTA)- National Institute for Health Research (NIHR), UK.

Who is the main contact?
Professor Alex Copello
a.g.copello@bham.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Alex Copello

ORCID ID

Contact details

School of Psychology
University of Birmingham
Edbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 7414
a.g.copello@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 11/60/01

Study information

Scientific title

Adaptation and feasibility study of a family and social network intervention for young people who misuse alcohol and drugs

Acronym

Youth-SBNT

Study hypothesis

Expressed in null form, the study hypothesis is that the Social and Family Intervention (Youth-Social Behaviour and Network Therapy) will be as effective and cost-effective as treatment as usual (TAU).

More details can be found at http://www.nets.nihr.ac.uk/projects/hta/116001
Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0005/81167/PRO-11-60-01.pdf

On 11/11/2014 the study design was changed from 'Prospective pragmatic randomised controlled trial' to 'Pragmatic pilot feasibility randomised controlled trial'.

Ethics approval

NRES Committee West Midlands - Coventry & Warwickshire, 24/02/2014, REC ref: 14/WM/0021

Study design

Pragmatic pilot feasibility randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Alcohol and drug addiction

Intervention

Each group will have 30 participants (N=30 allocated to Youth-Social Behaviour and Network Therapy and N=30 allocated to Treatment as Usual).

Young people randomised to SBNT will be offered 6, weekly, 50-minute SBNT sessions for a period of a maximum of 12 weeks. Treatment as usual in the clinical centres (Newcastle and Birmingham) which will provide the comparison to the trial intervention is broadly similar. The fundamental contrast between the two treatments under study is that the trial intervention will have a family and social network focus and the treatment as usual will be individually focused. Young people randomised to receive treatment as usual will receive a similar number of individual sessions i.e.6 over a period of 12 weeks. Participants will then be followed up 3 and 12 months after baseline assessment.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The primary outcome measure for the pilot trial will be based on the Timeline Follow-Back (TLFB) interview and will be the proportion of days on which the main problem substance was used in the preceding 90 day period covered by each assessment point. The main problem substance will be that for which the referral to the services was made and this will be corroborated at the research assessment interview prior to completion of the TLFB.

Secondary outcome measures

Family-based approaches have the potential to impact on other facets of young people's lives and may lead to changes in a number of secondary areas including, family, psychological and social outcome variables that will be measured with validated questionnaires that have been widely used in trials of young people: The following measures will be used.
1. Emotional well-being: The Strengths and Difficulties Questionnaire (SDQ) (Goodman, 1997) has five separate sub-scales for different aspects of problems or behaviours: emotional problems, conduct/behaviour problems, inattention/hyperactivity, relationships with peers, and pro-socialbehaviour. The first four scales can be added together to produce a score for total difficulties.
2. Social Network Support: Given the emphasis on family and peer support of the intervention, the Important People Drug and Alcohol interview (IPDA) will be used in order to understand the influence of social support on treatment for substance misuse.
3. Family Environment: The Family Environment Scale (Moos and Moos, 1986) is designed to measure the atmosphere in the family household and will be used where appropriate to the circumstances of the participant. It is a 27-item measure and yields scores for family cohesion, free expression of emotion in the family and absence of open conflict.
4. Working Alliance Inventory (Horvath & Greenberg, 1989) will be administered at 3-month follow-up to the young people and also to the therapists delivering the intervention and treatment as usual. The questionnaire measures the perceived strength of the working alliance between therapists and their clients during therapy sessions.
5. School attendance and engagement, self-reported crime and health care and social services contact will be measured based on questionnaires used by the applicants in previous alcohol trials (UKATT Research Team, 2005; Coulton, 2009).
6. EQ-5DY (version of the EQ-5D validated with youth populations.

Overall trial start date

01/02/2014

Overall trial end date

01/11/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Patients are eligible if they meet all of the following:
1. Young people aged 12-18, either sex
2. Young people with drug and/or alcohol problems accepted for treatment by the two agencies and willing and able to provide written informed consent.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

60

Participant exclusion criteria

Patients are ineligible if any (one or more) of the following apply:
1. With concurrent severe mental illness
2. Pending imprisonment. (i.e. will not be available for follow-up)
3. With severe physical illness
4. Unable or unwilling to give written informed consent

Recruitment start date

01/02/2014

Recruitment end date

01/11/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Psychology
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

Birmingham and Solihull Mental Health NHS Foundation Trust (UK)

Sponsor details

c/o Dr Paul McDonald
Research Manager
Research & Innovation
Radclyffe House
66-68 Hagley Road
Birmingham
B16 8PF
United Kingdom
+44 (0)121 301 4330
paul.mcdonald@bsmhft.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.bsmhft.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK) ref: 11/60/01

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

2015 protocol in: http://www.pilotfeasibilitystudies.com/content/1/1/8

Publication citations

Additional files

Editorial Notes