Alcohol MisuseYSBNTNCT02399865
Family and Social Intervention for Young People
A study testing Youth Social Behaviour and Network Therapy in people with Alcohol Misuse and Drug Misuse, run by University of Birmingham.
Trial summary
Research evidence shows that there is a high prevalence of substance use among young people in the UK. Early onset and high levels of use are associated with a range of negative outcomes, including increased risk of later problematic use and dependence. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Misuse, Drug Misuse
- What is being tested?
- Youth Social Behaviour and Network Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Young people with drug and/or alcohol problems newly referred and accepted for treatment by the two agencies during the period of recruitment. (ii) Willing to provide written informed consent. (iii) Able to provide written informed consent.
Who cannot join
- Concurrent severe mental illness that precludes them from active participation.
- Severe physical illness that precludes them from active participation. (iii) Unable or unwilling to give written informed consent.
About this study
Official title: A Randomised Controlled Trial of Family and Social Network Intervention for Young People Who Misuse Alcohol and Drugs: a Feasibility Study [Y-SBNT]
Research evidence shows that there is a high prevalence of substance use among young people in the UK. Early onset and high levels of use are associated with a range of negative outcomes, including increased risk of later problematic use and dependence. A growing body of research has identified family interventions to be effective in treating young people's substance use problems. However, despite this evidence, takeup of family based approaches, at least in the UK, has been low. A key factor appears to be the resource intensive nature of many family interventions, making them difficult to implement and deliver in many service settings, especially in the context of substantial cuts to drug and alcohol services for young people (1). Another potential barrier may be the cultural adaptation of approaches developed in the USA to a UK setting. There is growing awareness of the need to adapt evidence-based treatments to different cultural groups and settings in order to ensure successful implementation (2,3,4).
Following on from developmental and adaptation work, this study aims to demonstrate the feasibility of recruiting young people to specifically developed family and network based intervention. In addition the feasibility of training staff from existing young people addiction services to deliver this intervention will be explored and treatment retention will be assessed. Qualitative interviews will elicit the participants' views on the acceptability of the intervention and their experiences of both it and the study process.
Read the detailed description
Following the adaptation, we developed a manualised family-based intervention for young substance misusers up to the age of 18. This was an evidence-based approach, drawing on our previous research, a review of the literature and the views of young substance misusers with experience of treatment (Phase 1).
We aim to undertake a smallscale trial in two sites (Phase 2), to assess both the feasibility of the intervention and the scope for moving to a full trial of clinical and cost effectiveness. We also aim to evaluate the implementation of this new intervention using mixed methods research , monitoring randomisation procedures, treatment fidelity, staff time (and associated costs), engagement, retention and a range of outcome measures, reflecting the multiple vulnerabilities of this population. We will thereby address the brief's central aims of assessing the feasibility of a familybased intervention with this group and whether a trial could be successfully undertaken.
Phase 1: Intervention Development Using the original Intervention structure and content as a platform, the overall aim was to adapt this family and social intervention in collaboration with those who have experience of using services in order to ensure that it is acceptable to young people and their families, remains focused on the important aspects that promote and support behaviour change and yet is realistic and deliverable in a way that maximises treatment engagement, taking into account young people's views and preferences. The resulting intervention will therefore be one in which much of the original material is oriented to a youth population, whilst retaining the key principles of the original Social Behaviour and Network Therapy. At the time of completing this ethics application, two of the three key sources of information which informed this process were already carried out. First, a Systematic Review was conducted on the already existing evidencebase on the effectiveness and acceptability of family based interventions in treating young people's substance abuse. Second, Patient and Public Involvement (PPI) was carried out by actively engaging a sample of young people with a history of treatment for substance abuse in a number of consultation processes. Third, we are yet to explore the the point of view of those who will deliver the intervention by drawing on a group of therapists and service managers working in child and adolescent addiction services. This group will comment on each stage of the intervention and handbook design, being invited to 'walk through' the delivery of this new intervention.
Phase 2: Feasibility Randomised Controlled Trial (RCT) The purpose of this ethics application is to obtain ethical approval for this specific phase of our study. For phase 2 we propose a prospective pragmatic randomised controlled trial to assess the feasibility and impact of the adapted family and social network intervention for drug and alcohol misuse in young people. The proposed trial will use concealed randomisation, intention to treat analysis and characterisation of refusers and dropouts. It will be a pragmatic trial, delivered in two Young People services. It involves a parallel group design comparing two conditions: (i) Adapted youth social network intervention (YouthSBNT) and (ii) Treatment as usual.
For those that agree to participate, the researcher will:
- Obtain written consent from them to participate in the trial;
- Conduct a baseline assessment;
- Telephone the York Trials Unit Freephone randomisation service or use the online system to randomise the patient (hereafter referred to as the participant);
- Provide the participant with an appointment to see the therapist or clinician appropriate to their allocation.
At baseline, information will be collected from the patient regarding their drug and alcohol use, emotional wellbeing, social network, family environment, quality of life, school attendance, selfreported crime, health care use, social services contact, and demographics. The same set of information will be collected at 3 months and 12 months follow up postrandomisation assessments. Interviews will be undertaken by the research fellows, covering the main and secondary outcome measures mentioned earlier. In addition, qualitative interviews will be used to explore the acceptability and wider context of the impact of the intervention to the young people and their family members/social network. Economic evaluation will also be conducted to inform larger definitive trial.
- Conditions
- Alcohol Misuse, Drug Misuse
- Being tested
- Youth Social Behaviour and Network Therapy
- Medical subject headings
- Drug Misuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Youth Social Behaviour and Network TherapyOther
Also called YSBNT
The Y-SBNT will be delivered according to the developed purpose-designed therapy manual. Participants randomised to Y-SBNT will be offered six, 50 minute SBNT sessions for over a maximum period of 12 weeks. Where consent is obtained, sessions will audio-recorded and reviewed by the research team to ensure fidelity with the YSBNT manual and principles of practice.
Using the identification of the social network of the young person conducted in the first session as a platform, subsequent core strategies of the adapted YSBNT approach include motivational techniques, improving communication and coping mechanisms, and crucially given the nature of substance misuse, developing a network-based relapse management plan. Participants will be given the opportunity to invite members of their network to the treatment sessions. The therapeutic approach also has scope to address client-focussed elective areas, for example, educational requirements.
| Study group | Role | What they receive |
|---|---|---|
| YSBNT Group | Experimental | Six 50 minute YSBNT sessions (delivered by a trained YSBNT practitioner) for over a maximum period of 12 weeks Receives: Other: Youth Social Behaviour and Network Therapy |
| Treatment as Usual Group | No intervention | Usual care delivered by treatment-as-usual practitioners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Quantitative assessment of the acceptability of the research will be assessed by numbers referred, number eligible and those agreeing to participate.
Measured: 3 months
Retention in Treatment
Retention in treatment will be evaluated by number of sessions attended as a measure of acceptability of the interventions to participants.
Measured: 3 months (12 weeks)
Follow up completion rates
Quantitative assessment of the number of follow-up interviews completed.
Measured: 12 months
Secondary outcomes (6)
Qualitative Interviews
The acceptability of the Y-SBNT intervention to the young people and the wider context of the impact of the intervention will be explored by undertaking semi-structured qualitative interviews conducted at three and 12 months post-randomisation. In addition, the acceptability of the intervention to those attending as network members will be explored through similarly semi-structured interviews at three months post-randomisation.
Measured: 3 to 12 months
Emotional Well-being as measured by Social Difficulties Questionnaire (SDQ)
Emotional well-being will be measured at baseline, three and 12 months post-randomisation using the Strengths and Difficulties Questionnaire (SDQ) has five separate sub-scales for different aspects of problems or behaviours: emotional problems, conduct/behaviour problems, inattention/hyperactivity, relationships with peers, and pro-social behaviour. The first four scales can be added together to produce a score for total difficulties. The SDQ has been used extensively and has demonstrated high levels of reliability and validity
Measured: 12 months
Social Network Support as measured by Important People Drug and Alcohol interview (IPDA)
Given the emphasis on family and peer support of the intervention, social network support will be measured at baseline, three and 12 months post-randomisation using the IPDA in order to understand the influence of social support on treatment for substance misuse. Researchers have described 4 sub-types of support: General structural support refers to embeddedness in a social network. e.g. number of close friends; Abstinence-specific structural support is the prevalence of nondrug or alcohol users relative to drug or alcohol users in the social network; General functional support refers to assistance from others that does not specifically address drug or alcohol use (e.g. giving advice); Abstinence-specific functional support consists of behaviours that focus on abstinence or substance use more directly, such as encouraging someone to remain in treatment or (as a negative example) offering alcohol or drugs. These four areas will be covered using the IPDA.
Measured: 12 months
Family Environment as measured by Family Environment Scale (FES)
Family environment will be measured at baseline, three and 12 months post-randomisation using the 27-item Relationship dimension of the FES consisting of Cohesion, Expressiveness, and Conflict subscales (9 items each). It is designed to measure the atmosphere in the family household and will be used where appropriate to the circumstances of the participant. These subscales measure support, expression of opinions, and angry conflict within a family. This 27-item measure has been used by some of the applicants in previous studies and yields scores for family cohesion, free expression of emotion in the family and absence of open conflict.
Measured: 12 months
Working Alliance Inventory
Working Alliance Inventory will be administered at end of treatment sessions one and three 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. The young people will be provided with envelopes to seal their completed WAI in.
Measured: 3 months
Health Related Quality of Life (HRQoL)
HRQoL will be assessed at baseline, three and 12 months post-randomisation using the European Quality of Life - 5 Dimensions-5 levels (EQ-5D-5L). EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal, where health is characterised on five dimensions (mobility, self-care, ability to undertake usual activities, pain, anxiety / depression).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startMay 2014
- Primary completionSep 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol MisuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of York, Birmingham and Solihull Mental Health NHS Foundation Trust, National Institute for Health Research, United Kingdom, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle University
- Responsible party
- Sponsor
- Investigators
- Alex G Copello, PhD, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399865
- Sponsor's protocol ID
- NIHR 11/60/01
- Acronym
- YSBNT
- Status last verified
- Mar 2015
- First submitted
- 23 Mar 2015
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
1.Drugscope. Charities warn of 'devastating impact' of cuts to young people's drug and alcohol services. 2011; 20 July. 2.Bernal G, JimenezChafey M, Domenech Rodriquez MM. Cultural adaptation of treatments: a resource for considering culture in evidencebased practice. Professional Psychology; Research and Practice. 2009: 40 (4); 361368. 3.Cortese CA (1999). Drug services and cultural adaptation. Drugs: education, prevention and policy. 1999: 6 (3); 361366 4.Lau, A.S. Making the case for selective and directed cultural adaptations of evidence-based treatments: examples from parent training. Clin Psychol Sci Prac. 2006: 13; 295310.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Family and Social Network Intervention for Young People Who Misuse Alcohol and Drugs: a Feasibility Study [Y-SBNT]
- ClinicalTrials.gov ID
- NCT02399865
- Acronym / sponsor ID
- YSBNT / NIHR 11/60/01
- Conditions
- Alcohol Misuse, Drug Misuse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- University of York, Birmingham and Solihull Mental Health NHS Foundation Trust, National Institute for Health Research, United Kingdom, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle University
- Study start
- May 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research evidence shows that there is a high prevalence of substance use among young people in the UK. Early onset and high levels of use are associated with a range of negative outcomes, including increased risk of later problematic use and dependence. A growing body of research has identified family interventions to be effective in treating young people's substance use problems. However, despite this evidence, takeup of family based approaches, at least in the UK, has been low. A key factor appears to be the resource intensive nature of many family interventions, making them difficult to implement and deliver in many service settings, especially in the context of substantial cuts to drug and alcohol services for young people (1). Another potential barrier may be the cultural adaptation of approaches developed in the USA to a UK setting. There is growing awareness of the need to adapt evidence-based treatments to different cultural groups and settings in order to ensure successful implementation (2,3,4).
Following on from developmental and adaptation work, this study aims to demonstrate the feasibility of recruiting young people to specifically developed family and network based intervention. In addition the feasibility of training staff from existing young people addiction services to deliver this intervention will be explored and treatment retention will be assessed. Qualitative interviews will elicit the participants' views on the acceptability of the intervention and their experiences of both it and the study process.
Detailed description
Following the adaptation, we developed a manualised family-based intervention for young substance misusers up to the age of 18. This was an evidence-based approach, drawing on our previous research, a review of the literature and the views of young substance misusers with experience of treatment (Phase 1).
We aim to undertake a smallscale trial in two sites (Phase 2), to assess both the feasibility of the intervention and the scope for moving to a full trial of clinical and cost effectiveness. We also aim to evaluate the implementation of this new intervention using mixed methods research , monitoring randomisation procedures, treatment fidelity, staff time (and associated costs), engagement, retention and a range of outcome measures, reflecting the multiple vulnerabilities of this population. We will thereby address the brief's central aims of assessing the feasibility of a familybased intervention with this group and whether a trial could be successfully undertaken.
Phase 1: Intervention Development Using the original Intervention structure and content as a platform, the overall aim was to adapt this family and social intervention in collaboration with those who have experience of using services in order to ensure that it is acceptable to young people and their families, remains focused on the important aspects that promote and support behaviour change and yet is realistic and deliverable in a way that maximises treatment engagement, taking into account young people's views and preferences. The resulting intervention will therefore be one in which much of the original material is oriented to a youth population, whilst retaining the key principles of the original Social Behaviour and Network Therapy. At the time of completing this ethics application, two of the three key sources of information which informed this process were already carried out. First, a Systematic Review was conducted on the already existing evidencebase on the effectiveness and acceptability of family based interventions in treating young people's substance abuse. Second, Patient and Public Involvement (PPI) was carried out by actively engaging a sample of young people with a history of treatment for substance abuse in a number of consultation processes. Third, we are yet to explore the the point of view of those who will deliver the intervention by drawing on a group of therapists and service managers working in child and adolescent addiction services. This group will comment on each stage of the intervention and handbook design, being invited to 'walk through' the delivery of this new intervention.
Phase 2: Feasibility Randomised Controlled Trial (RCT) The purpose of this ethics application is to obtain ethical approval for this specific phase of our study. For phase 2 we propose a prospective pragmatic randomised controlled trial to assess the feasibility and impact of the adapted family and social network intervention for drug and alcohol misuse in young people. The proposed trial will use concealed randomisation, intention to treat analysis and characterisation of refusers and dropouts. It will be a pragmatic trial, delivered in two Young People services. It involves a parallel group design comparing two conditions: (i) Adapted youth social network intervention (YouthSBNT) and (ii) Treatment as usual.
For those that agree to participate, the researcher will:
- Obtain written consent from them to participate in the trial;
- Conduct a baseline assessment;
- Telephone the York Trials Unit Freephone randomisation service or use the online system to randomise the patient (hereafter referred to as the participant);
- Provide the participant with an appointment to see the therapist or clinician appropriate to their allocation.
At baseline, information will be collected from the patient regarding their drug and alcohol use, emotional wellbeing, social network, family environment, quality of life, school attendance, selfreported crime, health care use, social services contact, and demographics. The same set of information will be collected at 3 months and 12 months follow up postrandomisation assessments. Interviews will be undertaken by the research fellows, covering the main and secondary outcome measures mentioned earlier. In addition, qualitative interviews will be used to explore the acceptability and wider context of the impact of the intervention to the young people and their family members/social network. Economic evaluation will also be conducted to inform larger definitive trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YSBNT Group | Experimental | Other: Youth Social Behaviour and Network TherapySix 50 minute YSBNT sessions (delivered by a trained YSBNT practitioner) for over a maximum period of 12 weeks |
| Treatment as Usual Group | No intervention | –Usual care delivered by treatment-as-usual practitioners |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Young people with drug and/or alcohol problems newly referred and accepted for treatment by the two agencies during the period of recruitment. (ii) Willing to provide written informed consent. (iii) Able to provide written informed consent.
Key exclusion criteria (2 listed)
- Concurrent severe mental illness that precludes them from active participation.
- Severe physical illness that precludes them from active participation. (iii) Unable or unwilling to give written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Youth Social Behaviour and Network TherapyAlso: YSBNTThe Y-SBNT will be delivered according to the developed purpose-designed therapy manual. Participants randomised to Y-SBNT will be offered six, 50 minute SBNT sessions for over a maximum period of 12 weeks. Where consent is obtained, sessions will audio-recorded and reviewed by the research team to ensure fidelity with the YSBNT manual and principles of practice. Using the identification of the social network of the young person conducted in the first session as a platform, subsequent core strategies of the adapted YSBNT approach include motivational techniques, improving communication and coping mechanisms, and crucially given the nature of substance misuse, developing a network-based relapse management plan. Participants will be given the opportunity to invite members of their network to the treatment sessions. The therapeutic approach also has scope to address client-focussed elective areas, for example, educational requirements. | Other | YSBNT Group |
Primary outcome
Recruitment Rate
Time frame: 3 months
Quantitative assessment of the acceptability of the research will be assessed by numbers referred, number eligible and those agreeing to participate.
Retention in Treatment
Time frame: 3 months (12 weeks)
Retention in treatment will be evaluated by number of sessions attended as a measure of acceptability of the interventions to participants.
Follow up completion rates
Time frame: 12 months
Quantitative assessment of the number of follow-up interviews completed.
6 secondary outcomes
Qualitative Interviews
Time frame: 3 to 12 months
Emotional Well-being as measured by Social Difficulties Questionnaire (SDQ)
Time frame: 12 months
Social Network Support as measured by Important People Drug and Alcohol interview (IPDA)
Time frame: 12 months
Family Environment as measured by Family Environment Scale (FES)
Time frame: 12 months
Working Alliance Inventory
Time frame: 3 months
Health Related Quality of Life (HRQoL)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
- Background1.Drugscope. Charities warn of 'devastating impact' of cuts to young people's drug and alcohol services. 2011; 20 July. 2.Bernal G, JimenezChafey M, Domenech Rodriquez MM. Cultural adaptation of treatments: a resource for considering culture in evidencebased practice. Professional Psychology; Research and Practice. 2009: 40 (4); 361368. 3.Cortese CA (1999). Drug services and cultural adaptation. Drugs: education, prevention and policy. 1999: 6 (3); 361366 4.Lau, A.S. Making the case for selective and directed cultural adaptations of evidence-based treatments: examples from parent training. Clin Psychol Sci Prac. 2006: 13; 295310.
- Protocol paper published in Pilot and Feasibility StudiesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex G Copello, PhD principal investigator
University of Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing Youth Social Behaviour and Network Therapy in people with Alcohol Misuse and Drug Misuse, run by University of Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02399865, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.