Assessing the Efficacy of a Brief Universal Family Skills Programme on Violence and Substance-Use Indicators in Youth in Trentino and Parma, Italy: Study Protocol for a Multi-Centre, Non-Blinded, Cluster-Randomised Controlled Trial (cRCT) of Family UNited

Homes in which families are experiencing stressful and challenging circumstances can foster a social space that engenders violent behaviours in parents, inadequate childcare, and the exposure of children to criminal and antisocial behaviours at an early age in addition to many other negative social and health consequences throughout their development. Family Skills Training offers a combination of parenting knowledge, skill building, competency enhancement, and support to strengthen family protective factors, such as communication, trust, problem-solving skills, and conflict resolution. Through over a decade-long experience piloting evidence-based family skills packages globally, we developed a universal open-source family skills package, “Family UNited” (FU), designed for families with children aged 8 to 15 years living in low- and middle-income countries (LMIC). The current study aims to explore the efficacy, fidelity, and acceptability of FU in Trentino and Parma, Italy. We plan to conduct a multi-site, non-blinded, two-armed, cluster-randomised controlled trial to assess efficacy in 160 families: the intervention group receiving FU and the waitlist/control group only receiving FU after the completion of all data collection points. We will prospectively collect outcome data, assessing changes in parenting skills and family adjustment in caregivers, children’s behaviour, resilience capacities, and attitudes towards peer violence. To assess programme delivery, fidelity, feasibility, and acceptability we will include an embedded process evaluation. This study aims to evaluate the improvement in parenting skills, child well-being, and family mental health after participation in FU, compared to no intervention. Even though this trial is to be conducted in a high-income country, such results complement the existing piloting experience in LMIC. with impact-related measures encouraging the adoption of such approaches globally and beyond the EU borders.