RT Journal Article T1 Protocol for a randomized pilot study (FIRST STEPS): implementation of the Incredible Years-ASLD® program in Spanish children with autism and preterm children with communication and/or socialization difficulties A1 Valencia, Fátima A1 Urbiola, Elena A1 Romero-González, Marina A1 Navas, Inmaculada A1 Elías, María A1 Garriz, Alexandra A1 Ramírez, Almudena A1 Villalta, Laia K1 Parenting intervention K1 Pilot K1 ASD K1 Preterm children K1 Child development K1 Randomized controlled trial K1 Complex intervention K1 Responsabilidad parental K1 Pilotos K1 Trastorno del espectro del autismo K1 Nacimiento prematuro K1 Desarrollo infantil AB Having access to parenting interventions in the early years is key to improve the developmental outcomes of children with neurodevelopmental problems. The Incredible Years® (IY) Parent Program is a group intervention that has demonstrated efficacy in terms of reducing stress in parents, as well as improving behavioral, emotional, and social outcomes in children. The program has been recently adapted for families of children with autism or language delays (IY-ASLD®). This intervention has not yet been implemented in the Spanish Public Health System, where there is a scarcity of evidence-based interventions being offered to families with young children presenting neurodevelopmental problems. The main aims of this study are to determine the feasibility of implementing the IY-ASLD® program within Spanish Child Mental Health Services and to examine parents' acceptability and satisfaction with the intervention. As a secondary objective, we aim to evaluate its preliminary effectiveness in terms of reducing parental stress and behavioral difficulties in their children. The FIRST STEPS study is a multicenter, pilot randomized controlled trial comparing the IY-ASLD® program with a treatment-as-usual (TAU) condition. Approximately 70 families of children with autism spectrum disorder (ASD) and preterm children with communication and/or socialization difficulties (aged 2-5 years) will be recruited. Families will be assessed prior to randomization and after the intervention. Due to the COVID-19 pandemic, the intervention will consist of 22 weekly online sessions (approximately 6 months). The FIRST STEPS pilot trial will demonstrate the feasibility and acceptability of reliably implementing the IY-ASLD® program within the Spanish Public Health System. The results of this study could represent the first step to inform policymakers in Spain when designing evidence-based healthcare pathways for families of children presenting ASD symptoms or neurodevelopmental difficulties at early stages. PB BioMed Central YR 2021 FD 2021-04-20 LK http://hdl.handle.net/10668/4360 UL http://hdl.handle.net/10668/4360 LA en NO Valencia F, Urbiola E, Romero-González M, Navas I, Elías M, Garriz A, et al. Protocol for a randomized pilot study (FIRST STEPS): implementation of the Incredible Years-ASLD® program in Spanish children with autism and preterm children with communication and/or socialization difficulties. Trials. 2021 Apr 20;22(1):291 NO TRIAL REGISTRATION: ClinicalTrials.gov NCT04358484 . Registered on 04 April 2020. DS RISalud RD Apr 11, 2025