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      Randomized controlled internal pilot trial of a diversion programme for adolescents in police custody who possess illicit substances

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          Abstract

          Background

          Adolescents involved in criminal proceedings are significantly more likely to re-offend than a similar population diverted away from criminal justice. Adolescents who use substances and offend are at higher risk of experiencing negative social, psychological and physical problems that often persist into adulthood. There is some evidence that brief interventions combined with appropriate psychoeducation may be effective in reducing adolescent substance use.

          Methods

          Prospective two-armed, individually randomized internal pilot randomized controlled trial (RCT) with follow-up at 6 months. Young people across three police forces—Kent, Cornwall and Sefton—arrested in possession of class B or C illicit substances were randomly allocated to receive the ReFrame intervention or business as usual. In total, 102 participants were eligible of whom 76 consented and 73 were followed up at 6 months. Outcomes addressed offending behaviour, frequency of substance use, wellbeing and mental health. The study was conducted between February and December 2022.

          Results

          All progression criteria were met, 80% of those eligible consented, 96% adhered to their allocated treatment and 88% were followed up at the primary endpoint.

          Conclusions

          The feasibility of conducting the pilot trial was a success and it will now proceed to a definitive RCT.

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          Most cited references39

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          The Strengths and Difficulties Questionnaire: A Research Note

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            Design and analysis of pilot studies: recommendations for good practice

            Pilot studies play an important role in health research, but they can be misused, mistreated and misrepresented. In this paper we focus on pilot studies that are used specifically to plan a randomized controlled trial (RCT). Citing examples from the literature, we provide a methodological framework in which to work, and discuss reasons why a pilot study might be undertaken. A well-conducted pilot study, giving a clear list of aims and objectives within a formal framework will encourage methodological rigour, ensure that the work is scientifically valid and publishable, and will lead to higher quality RCTs. It will also safeguard against pilot studies being conducted simply because of small numbers of available patients.
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              Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study

              Background External pilot or feasibility studies can be used to estimate key unknown parameters to inform the design of the definitive randomised controlled trial (RCT). However, there is little consensus on how large pilot studies need to be, and some suggest inflating estimates to adjust for the lack of precision when planning the definitive RCT. Methods We use a simulation approach to illustrate the sampling distribution of the standard deviation for continuous outcomes and the event rate for binary outcomes. We present the impact of increasing the pilot sample size on the precision and bias of these estimates, and predicted power under three realistic scenarios. We also illustrate the consequences of using a confidence interval argument to inflate estimates so the required power is achieved with a pre-specified level of confidence. We limit our attention to external pilot and feasibility studies prior to a two-parallel-balanced-group superiority RCT. Results For normally distributed outcomes, the relative gain in precision of the pooled standard deviation (SD p ) is less than 10% (for each five subjects added per group) once the total sample size is 70. For true proportions between 0.1 and 0.5, we find the gain in precision for each five subjects added to the pilot sample is less than 5% once the sample size is 60. Adjusting the required sample sizes for the imprecision in the pilot study estimates can result in excessively large definitive RCTs and also requires a pilot sample size of 60 to 90 for the true effect sizes considered here. Conclusions We recommend that an external pilot study has at least 70 measured subjects (35 per group) when estimating the SD p for a continuous outcome. If the event rate in an intervention group needs to be estimated by the pilot then a total of 60 to 100 subjects is required. Hence if the primary outcome is binary a total of at least 120 subjects (60 in each group) may be required in the pilot trial. It is very much more efficient to use a larger pilot study, than to guard against the lack of precision by using inflated estimates.
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                Author and article information

                Contributors
                Journal
                J Public Health (Oxf)
                J Public Health (Oxf)
                pubmed
                Journal of Public Health (Oxford, England)
                Oxford University Press
                1741-3842
                1741-3850
                June 2024
                10 February 2024
                10 February 2024
                : 46
                : 2
                : e269-e278
                Affiliations
                Centre for Health Service Studies, University of Kent , Canterbury CT2 7NZ, UK
                Centre for Health Service Studies, University of Kent , Canterbury CT2 7NZ, UK
                Centre for Health Service Studies, University of Kent , Canterbury CT2 7NZ, UK
                Department of Psychology, University of Kent , Canterbury CT2 7NZ, UK
                We Are With You , Faversham, Kent ME13 8JD, UK
                We Are With You , Wigan WN1 1HR, UK
                We Are With You , Wigan WN1 1HR, UK
                Author notes
                Address correspondence to Simon Coulton, E-mail: s.coulton@ 123456kent.ac.uk
                Author information
                https://orcid.org/0000-0002-7704-3274
                https://orcid.org/0000-0001-6437-0826
                Article
                fdae017
                10.1093/pubmed/fdae017
                11141605
                38343024
                6040cdc0-34ed-40b6-b3f6-ad5a22ebd31b
                © The Author(s) 2024. Published by Oxford University Press on behalf of Faculty of Public Health.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

                History
                : 6 July 2023
                : 29 November 2023
                : 17 January 2024
                Page count
                Pages: 10
                Funding
                Funded by: Youth Endowment Fund, DOI 10.13039/501100024398;
                Categories
                Editor's Choice
                Original Article
                AcademicSubjects/MED00860

                Public health
                adolescent,brief intervention,diversion,psychoeducation,substance use,youth justice
                Public health
                adolescent, brief intervention, diversion, psychoeducation, substance use, youth justice

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