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

2020 ◽  
Vol 8 (13) ◽  
pp. 1-162
Author(s):  
Hayley Alderson ◽  
Eileen Kaner ◽  
Rebecca Brown ◽  
Denise Howel ◽  
Elaine McColl ◽  
...  
Keyword(s):  
Mental Health ◽  
Substance Use ◽  
Randomised Controlled Trial ◽  
Social Behaviour ◽  
Controlled Trial ◽  
Motivational Enhancement Therapy ◽  
Motivational Enhancement ◽  
Network Therapy ◽  
Randomised Controlled ◽  
Children In Care

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.

scholarly journals Enhancing help-seeking behaviour among men who have sex with men at risk for sexually transmitted infections: the syn.bas.in randomised controlled trial

2020 ◽  
pp. sextrans-2020-054438 ◽  
Author(s):  
Roeland Christiaan Alfons Achterbergh ◽  
Martijn S van Rooijen ◽  
Wim van den Brink ◽  
Anders Boyd ◽  
Henry John Christiaan de Vries
Keyword(s):  
Mental Health ◽  
Substance Use ◽  
Randomised Controlled Trial ◽  
Help Seeking ◽  
Controlled Trial ◽  
Risk Behaviour ◽  
Control Group ◽  
Help Seeking Behaviour ◽  
Sex With Men ◽  
Randomised Controlled

ObjectivesMen who have sex with men (MSM) are at increased risk for STIs and mental disorders. Syndemic theory holds that psychosocial issues co-occur and interact, and thus increase sexual risk behaviour. Psychosocial issue identification, referral and management might reduce risk behaviour.MethodsIn the syndemic-based intervention study, an open-label randomised controlled trial, MSM were enrolled at the STI outpatient clinic of the Public Health Service of Amsterdam. We screened participants using validated questionnaires on the following problem domains: alcohol and substance use, sexual compulsivity, anxiety, depression, attention deficit hyperactivity disorder, alexithymia, intimate partner violence and childhood sexual abuse. Individuals were randomly assigned (1:1) to receive either tailored, face-to-face feedback and help-seeking advice on mental health screening, or no feedback and no help-seeking advice. Participants were followed trimonthly for a year. The primary outcomes were self-reported and confirmed help-seeking behaviour.ResultsWe included 155 MSM: 76 in the intervention group and 79 in the control group. At inclusion, 128 participants (83.1%) scored positive in at least one problem domain. We found no significant differences in self-reported or confirmed help-seeking behaviour between the intervention and the control group: 41% vs 29% (p=0.14) and 28% vs 22% (p=0.44), respectively. There were also no differences in STI incidence and condomless anal sex acts between the two groups.ConclusionScreening showed high prevalence of problems related to mental health and substance use, while tailored feedback, advice and referral did not significantly increase help-seeking behaviour. Other interventions are needed to tackle the high burden of mental disorders among MSM.Trial registration numberNCT02859935.

scholarly journals Effects of an automated digital brief prevention intervention targeting adolescents and young adults with risky alcohol and other substance use: study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e034894
Author(s):  
Pia Kvillemo ◽  
Anna K Strandberg ◽  
Johanna Gripenberg ◽  
Anne H Berman ◽  
Charlotte Skoglund ◽  
...  
Keyword(s):  
Mental Health ◽  
Substance Use ◽  
Young Adults ◽  
Randomised Controlled Trial ◽  
Alcohol Use ◽  
Controlled Trial ◽  
Peer Pressure ◽  
Adolescents And Young Adults ◽  
Randomised Controlled

IntroductionAdolescence and young adulthood is a period in life when individuals may be especially vulnerable to harmful substance use. Several critical developmental processes are occurring in the brain, and substance use poses both short-term and long-term risks with regard to mental health and social development. From a public health perspective, it is important to prevent or delay substance use to reduce individual risk and societal costs. Given the scarcity of effective interventions targeting substance use among adolescents and young adults, cost-effective and easily disseminated interventions are warranted. The current study will test the effectiveness of a fully automated digital brief intervention aimed at reducing alcohol and other substance use in adolescents and young adults aged 15 to 25 years.Methods and analysisA two-arm, double-blind, randomised controlled trial design is applied to assess the effectiveness of the intervention. Baseline assessment, as well as 3-month and 6-month follow-up, will be carried out. The aim is to include 800 participants with risky substance use based on the screening tool CRAFFT (Car,Relax, Alone, Forget, Friends, Trouble). Recruitment, informed consent, randomisation, intervention and follow-up will be implemented online. The primary outcome is reduction in alcohol use, measured by Alcohol Use Disorders Identification Test total score. Secondary outcomes concern binge drinking, frequency of alcohol consumption, amount of alcohol consumed a typical day when alcohol is consumed, average daily drinks per typical week, other substance use, mental health, sexual risk behaviours and perceived peer pressure. Moreover, the study involves analyses of potential moderators including perfectionism, openness to parents, help-seeking and background variables.Ethics and disseminationThe study was approved by the Swedish Ethical Review Authority (no. 2019–03249). The trial is expected to expand the knowledge on digital preventive interventions for substance using adolescents and young adults. Results will be disseminated in research journals, at conferences and via the media.Trial registration number24 September 2019, ISRCTN91048246; Pre-results.

scholarly journals Digital cognitive–behavioural therapy for insomnia compared with digital patient education about insomnia in individuals referred to secondary mental health services in Norway: protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050661
Author(s):  
Håvard Kallestad ◽  
Simen Saksvik ◽  
Øystein Vedaa ◽  
Knut Langsrud ◽  
Gunnar Morken ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Patient Education ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Group Differences ◽  
Post Intervention ◽  
Cognitive Behavioural ◽  
Randomised Controlled

IntroductionInsomnia is highly prevalent in outpatients receiving treatment for mental disorders. Cognitive–behavioural therapy for insomnia (CBT-I) is a recommended first-line intervention. However, access is limited and most patients with insomnia who are receiving mental healthcare services are treated using medication. This multicentre randomised controlled trial (RCT) examines additional benefits of a digital adaptation of CBT-I (dCBT-I), compared with an online control intervention of patient education about insomnia (PE), in individuals referred to secondary mental health clinics.Methods and analysisA parallel group, superiority RCT with a target sample of 800 participants recruited from treatment waiting lists at Norwegian psychiatric services. Individuals awaiting treatment will receive an invitation to the RCT, with potential participants undertaking online screening and consent procedures. Eligible outpatients will be randomised to dCBT-I or PE in a 1:1 ratio. Assessments will be performed at baseline, 9 weeks after completion of baseline assessments (post-intervention assessment), 33 weeks after baseline (6 months after the post-intervention assessment) and 61 weeks after baseline (12 months after the post-intervention assessment). The primary outcome is between-group difference in insomnia severity 9 weeks after baseline. Secondary outcomes include between-group differences in levels of psychopathology, and measures of health and functioning 9 weeks after baseline. Additionally, we will test between-group differences at 6-month and 12-month follow-up, and examine any negative effects of the intervention, any changes in mental health resource use, and/or in functioning and prescription of medications across the duration of the study. Other exploratory analyses are planned.Ethics and disseminationThe study protocol has been approved by the Regional Committee for Medical and Health Research Ethics in Norway (Ref: 125068). Findings from the RCT will be disseminated via peer-reviewed publications, conference presentations, and advocacy and stakeholder groups. Exploratory analyses, including potential mediators and moderators, will be reported separately from main outcomes.Trial registration numberClinicalTrials.gov Registry (NCT04621643); Pre-results.

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