NCT02399865

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

1.3 years

First QC Date

March 23, 2015

Last Update Submit

March 26, 2015

Conditions

Outcome Measures

Primary Outcomes (3)

  • Recruitment Rate

    Quantitative assessment of the acceptability of the research will be assessed by numbers referred, number eligible and those agreeing to participate.

    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.

    3 months (12 weeks)

  • Follow up completion rates

    Quantitative assessment of the number of follow-up interviews completed.

    12 months

Secondary Outcomes (6)

  • Qualitative Interviews

    3 to 12 months

  • Emotional Well-being as measured by Social Difficulties Questionnaire (SDQ)

    12 months

  • Social Network Support as measured by Important People Drug and Alcohol interview (IPDA)

    12 months

  • Family Environment as measured by Family Environment Scale (FES)

    12 months

  • Working Alliance Inventory

    3 months

  • +1 more secondary outcomes

Other Outcomes (3)

  • Activities and Engagement

    12 months

  • Intervention effectiveness as measured by Timeline Follow-Back (TLFB)

    90 days

  • Young peoples' involvement

    24 months

Study Arms (2)

YSBNT Group

EXPERIMENTAL

Six 50 minute YSBNT sessions (delivered by a trained YSBNT practitioner) for over a maximum period of 12 weeks

Other: Youth Social Behaviour and Network Therapy

Treatment as Usual Group

NO INTERVENTION

Usual care delivered by treatment-as-usual practitioners

Interventions

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.

Also known as: YSBNT
YSBNT Group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • (i) 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.

You may not qualify if:

  • (i) Concurrent severe mental illness that precludes them from active participation.
  • (ii) Severe physical illness that precludes them from active participation. (iii) Unable or unwilling to give written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Drug Misuse

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Alex G Copello, PhD

    University of Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 26, 2015

Study Start

May 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

March 31, 2015

Record last verified: 2015-03