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

ABSTRACT: 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.

SUBMITTER: Arnaud N

PROVIDER: S-EPMC6988370 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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

Arnaud Nicolas N Baldus Christiane C Laurenz Léa Josette LJ Bröning Sonja S Brandt Maja M Kunze Sabrina S Austermann Maria M Zimmermann Linda L Daubmann Anne A Thomasius Rainer R

Trials 20200128 1

<h4>Background</h4>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 ...[more]

PMID: 31992356

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Project description:BackgroundThe Strengthening Families Program (SFP) is an evidence-based parent training and youth life skills and drug prevention program traditionally delivered in group settings. Families attend parent and youth classes conducted by trained facilitators. Recently, a 2-disk home-use DVD series was created with the same SFP skills as the group classes for parents and the youth to watch together at home. Additional lesson material was added that included healthy brain development, school success, anger management, dangers of alcohol and drugs, and mindfulness. The SFP DVD reduces SFP delivery costs for agencies and logistic burdens to families. Creative applications of the DVD include holding SFP DVD family discussion groups of multiple families and using SFP DVD video clips as part of a shorter 10-week group class version for parents and the youth.ObjectiveThis study aimed to examine three different DVD implementation scenarios using a noninferiority trial, contrasting target outcomes with an age-matched sample culled from a national norm database of families who completed a standard SFP 14-week class.MethodsThe partial eta-square was used to compare effect sizes between the different delivery modalities for relevant programmatic outcomes. We adjusted the effect sizes by demographic measures to determine whether there were site-specific features influencing program outcomes.ResultsFor the unadjusted effect size comparisons, 13 of the 15 indicated that the home-use DVD outperformed group norms with an average 0.13 effect size estimate difference across the comparisons (28% improvement in the effect size for DVD condition). Comparisons of the home-use DVD condition with the mixed DVD use conditions showed no discernable pattern where one condition consistently outperformed another. Adjusted effect sizes still reinforced the superiority of the DVD conditions; however, there was some shrinkage in the effect sizes as expected with the inclusion of relevant covariates.ConclusionsThe home-use DVD shows that it is possible to effectively deliver an affordable family-based intervention using alternative technology outside of the traditional group-based class format. In almost all of the comparisons, the DVD conditions outperformed the group norms, underscoring that low-cost DVDs or viewing the videos on the Web may provide a useful surrogate for costly group-based formats. Future studies may want to improve on the quasi-experimental design by examining programmatic differences based on delivery format using a randomized controlled trial, thus strengthening the causal framework regarding program effects. In addition, the assessment protocol relied on retrospective reporting, which, although this can limit response shift bias, does not separate data collection in time as with a true pre- and posttest design.

Dataset Information

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

Publications

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

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