Evaluation of the mindfulness-augmented "Trampoline" programme - a German prevention programme for children from substance-involved families tested in a cluster-randomised trial.

Background: Children of substance-abusing parents are at a substantial risk of developing substance-use and other mental disorders. Children involved in substance abuse - not diagnosed with substance-use problems but integrated in psychiatric treatment or youth welfare services - constitute a particular high-risk group that is in need of substance use prevention. Emerging evidence indicates that self-regulatory determinants of substance use and other mental disorders, particularly stress reactivity, are modifiable by mindfulness-based interventions, such as mindfulness-based stress reduction.

Methods: In this ongoing cluster randomised-controlled trial, a mindfulness-augmented version of the modularised evidence-based "Trampoline" programme for children affected by parental substance use problems is evaluated in a sample of 420 children who are from substance-involved families, aged from 8 to 12 and receiving non-substance-specific care in psychiatric or youth welfare services. Larger effects on adaptive stress-coping strategies (primary outcome), internalising and externalising problem behaviours and distress due to parental substance use are expected compared to the standard "Trampoline"-programme version. Mindfulness components will be added and regularly practiced for 30 min in each validated "Trampoline" module. Moreover, the feasibility of mindfulness-based interventions in psychiatric care and youth welfare services for children suffering from emotional and behavioural problems will be investigated in this study.

Discussion: Despite recruitment challenges, this study provides a unique opportunity to develop and test a promising addiction-specific, mindfulness-based intervention for a target group at risk, i.e. children from substance-involved families.

Trial Registration: The trial was registered in the German Clinical Trials Register on July 16th 2018 (trial registration number (TRN): DRKS00013533 ). Any important protocol modifications are to be reported immediately. Protocol version v.2.1, 15th April 2019.