Does a mindfulness-augmented version of the German Strengthening Families Program reduce substance use in adolescents? Study protocol for a randomized controlled trial

BACKGROUND: Mindfulness training (MT) for parents of adolescents has been shown to improve mental health and stress-related outcomes in individuals and their families. Studies of MT among young people are mainly delivered in educational or clinical settings, and there is a need for controlled studies on both parent-directed and adolescent-directed approaches. It is unclear whether MT has preventive effects for substance use outcomes. The primary objective of this trial is to evaluate the effectiveness of family-based MT targeting both adolescents and their parents to prevent adolescent substance use and enhance neurobehavioral self-regulation skills that play a major role in addiction development and mental health. METHODS/DESIGN: The trial design is a superiority, two-arm, randomized controlled trial in which families will participate either in the full curriculum of the evidence-based Strengthening Families Program 10–14 (SFP 10–14, German adaptation) or in a mindfulness-enhanced version of this program (SFP-Mind). Both seven-session interventions are highly structured and will each be delivered over a period of approximately 7 weeks. The experimental intervention SFP-Mind is a modified version of the SFP 10–14 in which some elements were eliminated or changed to enable the inclusion of additional parent-directed and adolescent-directed mindfulness components. The primary outcome is adolescent self-reported alcohol use based on an alcohol initiation index at 18-month follow-up. Dispositional mindfulness, impulsivity, and emotion regulation will be included as secondary outcomes and potential mechanisms of action. The study will recruit and randomize 216 adolescents, aged 10–14 years, and their parents who will be followed up for 18 months. DISCUSSION: This trial aims to evaluate the effectiveness of SFP-Mind for family-based prevention of substance use and promoting mental health in adolescence. TRIAL REGISTRATION: German Register of Clinical Studies, DRKS00015678. Registered on 25 February 2019.