Behaviour change interventions to reduce risky substance use and improve mental health in children in care: the SOLID three-arm feasibility RCT

Background Looked-after children and care leavers (henceforth children in care) are young people placed under the care of local authorities, often because of a history of family abuse and/or neglect. These young people have significantly increased risk of substance use and mental health problems compared with peers. Aim The Supporting Looked After Children and Care Leavers In Decreasing Drugs, and alcohol (SOLID) trial aimed to investigate the feasibility of a definitive randomised controlled trial comparing two behaviour change interventions to reduce risky substance use (illicit drugs and alcohol) in and improve the mental health of children in care aged 12–20 years. Methods The study consisted of two phases: (1) a formative phase that adapted the motivational enhancement therapy and social behaviour and network therapy interventions for use with children in care and (2) a three-arm pilot randomised controlled trial (comparing motivational enhancement therapy, social behaviour and network therapy and usual care), and a linked process and economic (return on investment) evaluation. Trial feasibility was compared with prespecified STOP/GO criteria. Setting Six local authority areas in the north-east of England. Participants Children in care (aged 12–20 years) who screened positive for drug and/or alcohol use within the last 12 months were eligible for the trial. The formative and process evaluations included children in care, carers, social workers, and drug and alcohol workers. Outcome measures The primary outcomes were recruitment and retention rates at 12 months’ follow-up. Baseline and 12-month follow-up questionnaires measured self-reported drug and alcohol use, mental health and health-related quality of life. The process evaluation considered acceptability and engagement with the interventions and trial procedures. Results Formative findings (n = 65) highlighted the need for interventions to increase the emphasis on therapeutic relationships, use creative methods of engagement and support the identification of treatment goals wider than substance misuse. Within the randomised controlled trial, of 860 participants screened, 211 (24.5%) met the inclusion criteria. One hundred and twelve (53%) of the 211 eligible children were recruited and randomised. Just 15 of the 76 (20%) participants allocated to intervention attended any of the motivational enhancement therapy of social behaviour and network therapy sessions, and 60 (54%) participants completed the 12-month follow-up. The screening and recruitment of children in care required significantly more time and resource investment by researchers and children’s services than planned. The process evaluation (n = 116) demonstrated that, despite participants engaging in risky substance use, they did not often acknowledge this nor felt that they needed help. Children in care had complex, chaotic lives and children’s services departments were less research mature and extremely stretched; this, coupled with the multiple steps in the intervention pathway and study protocol, resulted in low adherence to the intervention and the trial. Conclusions The SOLID trial demonstrated successful engagement with children in care to adapt the motivational enhancement therapy and social behaviour and network therapy interventions. However, the pilot randomised controlled trial found that a definitive trial is not feasible. The current screen, refer and treat pathway for children in care did not work. There is an urgent need to radically rethink how we deliver therapeutic services for children in care. A pragmatic evaluation design, coupled with additional research resource for children’s services, is needed to evaluate these novel models of care at scale. Trial registration This study is registered as PROSPERO CRD42018098974 and Current Controlled Trials ISRCTN80786829. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 13. See the NIHR Journals Library website for further project information.

Youth social behaviour and network therapy (Y-SBNT): adaptation of a family and social network intervention for young people who misuse alcohol and drugs – a randomised controlled feasibility trial

BackgroundFamily interventions appear to be effective at treating young people’s substance misuse. However, implementation of family approaches in UK services is low. This study aimed to demonstrate the feasibility of recruiting young people to an intervention based on an adaptation of adult social behaviour and network therapy. It also sought to involve young people with experience of using substance misuse services in the research process.ObjectivesTo demonstrate the feasibility of recruiting young people to family and social network therapy and to explore ways in which young people with experience of using substance misuse services could be involved in a study of this nature.DesignA pragmatic, two-armed, randomised controlled open feasibility trial.SettingTwo UK-based treatment services for young people with substance use problems, with recruitment taking place from May to November 2014.ParticipantsYoung people aged 12–18 years, newly referred and accepted for structured interventions for drug and/or alcohol problems.InterventionsA remote, web-based computer randomisation system allocated young people to adapted youth social behaviour and network therapy (Y-SBNT) or treatment as usual (TAU). Y-SBNT participants were intended to receive up to six 50-minute sessions over a maximum of 12 weeks. TAU participants continued to receive usual care delivered by their service.Main outcome measuresFeasibility was measured by recruitment rates, retention in treatment and follow-up completion rates. The main clinical outcome was the proportion of days on which the main problem substance was used in the preceding 90-day period as captured by the Timeline Follow-Back interview at 3 and 12 months.ResultsIn total, 53 young people were randomised (Y-SBNT,n = 26; TAU,n = 27) against a target of 60 (88.3%). Forty-two young people attended at least one treatment session [Y-SBNT 22/26 (84.6%); TAU 20/27 (74.1%)]; follow-up rates were 77.4% at month 3 and 73.6% at month 12. Data for nine young people were missing at both months 3 and 12, so the main clinical outcome analysis was based on 24 young people (92.3%) in the Y-SBNT group and 20 young people (74.1%) in the TAU group. At month 12, the average proportion of days that the main problem substance was used in the preceding 90 days was higher in the Y-SBNT group than in the TAU group (0.54 vs. 0.41; adjusted mean difference 0.13, 95% confidence interval –0.12 to 0.39;p = 0.30). No adverse events were reported. Seventeen young people with experience of substance misuse services were actively involved throughout the study. They informed key elements of the intervention and research process, ensuring that the intervention was acceptable and relevant to our target groups; contributing to the design of key trial documents, ideas for a new model of public involvement and this report. Two parents were also involved.ConclusionsThe adapted intervention could be delivered in young people’s services, and qualitative interviews found that Y-SBNT was acceptable to young people, family members and staff. Engagement of family and network members proved difficult within the intervention and research aspects. The study proved the feasibility of this work in routine services but outcome measurement based on narrow substance use variables may be limited and may fail to capture other important changes in wider areas of functioning for young people. Validation of the EuroQol-5 Dimensions for young people aged 12–18 years should be considered and flexible models for involvement of young people in research are required to achieve inclusive representation throughout all aspects of the research process. Although recommendation of a full trial of the Y-SBNT intervention compared with TAU is not supported, this study can inform future intervention development and UK research within routine addiction services.Trial registrationCurrent Controlled Trials ISRCTN93446265.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 15. See the NIHR Journals Library website for further project information.