Effectiveness of a mindfulness-oriented substance use prevention program for boys with mild to borderline intellectual d
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STUDY PROTOCOL
Open Access
Effectiveness of a mindfulness-oriented substance use prevention program for boys with mild to borderline intellectual disabilities: study protocol for a randomised controlled trial Lucie Waedel1, Anne Daubmann2, Antonia Zapf2 and Olaf Reis1*
Abstract Background: Boys with mild to borderline intellectual disabilities (MBID) are at particular risk to drink in harmful ways once they start to consume alcohol. Interventions based on mindfulness have been proven to be effective in preventing substance use, but mostly for adults with MBID. A mindfulness oriented intervention targeting 11–17 years old boys will be tested in a randomised controlled trial. Study aim is to investigate the benefits of this new intervention compared to an active control condition within a 12 months follow-up. Methods: In this randomised controlled proof of concept study, 82 boys with MBID who consumed any alcohol during the last year will be randomised either to the 6 week mindfulness oriented intervention or the control group receiving a control intervention equal in dose and length. The intervention group undergoes mindfulness training combined with interactive drug education, while the control group completes a health training combined with the same education. In the intention-to-treat analysis the primary outcome is the self-reported delay of first post-intervention drunkeness within a 12 months follow-up time span, measured weekly with a short app-based questionnaire. Secondary outcome is the use of alcohol, tobacco and other drugs within 30 days post-intervention. Changes in neurobiological behavioural parameters, such as impulse control, reward anticipation, and decision making, are also investigated. Other secondary outcomes regard trait mindfulness, emotion regulation, psychopathological symptoms, peer networks, perceived stress, and quality of life. In addition, a prospective registry will be established to record specific data on the population of 11–17 year old boys with MBID without any alcohol experience. Discussion: This study offers the opportunity to gain first evidence of the effectiveness of a mindfulness-oriented program for the prevention of substance use for boys with MBID. Trial registration: German Clinical Trials Register, DRKS00014042. Registered on March 19th 2018. Keywords: Mild to borderline intellectual disability, Alcohol, Prevention, Adolescents, Mindfulness, Substance use
* Correspondence: [email protected]; [email protected] 1 Department of Child and Adolescent Psychiatry and Neurology, University Medical Centre Rostock, Gehlsheimer Str. 20, 18147 Rostock, Germany Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative
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