Protocol for a randomized pilot study (FIRST STEPS): implementation of the Incredible Years-ASLD\xae program in Spanish children with autism and preterm children with communication and/or socialization difficulties

Fátima Valencia,María Elías,Marina Romero-González,Laia Villalta,Alexandra Garriz,Elena Urbiola,Almudena Ramírez,Inmaculada Navas

doi:10.1186/s13063-021-05229-1

Abstract

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.Trial registrationClinicalTrials.gov NCT04358484. Registered on 04 April 2020

Highlights

Autism spectrum disorder (ASD) is a neurodevelopmental disorder involving social communication disturbances and a restricted pattern of interests, present before age 3 [1].Preterm children are at particular risk of presenting a broad range of developmental difficulties, such as language delay, communication and social disturbances, and ASD [2,3,4]
In order to achieve these goals, we designed a controlled randomized pilot study that will be conducted within the Spanish Public Health System, where participating families will be randomly allocated to the intervention group or to the treatment as usual condition (TAU) on a 1:1 ratio
Eligibility criteria Different inclusion criteria were introduced for each site, given that the study was conducted in specialist ASD units in the Hospital Materno-Infantil in Málaga (HMIM) and Hospital General Universitario Gregorio Marañón in Madrid (HGUGM) sites, and in a specialized unit for preterm children at risk of developmental disorders in the Hospital Sant Joan de Déu in Barcelona (HSJD) site

Summary

Introduction

Autism spectrum disorder (ASD) is a neurodevelopmental disorder involving social communication disturbances and a restricted pattern of interests, present before age 3 [1]. Group interventions (the Incredible Years Autism Spectrum and Language Delays program: IY-ASLD®) Group interventions show promise as a valuable resource to help parents cope with children’s behavioral, social, and emotional difficulties This therapeutic approach has demonstrated effectiveness in terms of improving dysfunctional parenting styles, reducing children’s behavioral problems [18] and increasing parents’ ability to facilitate their children’s communication skills and vocabulary [19, 20]. In order to achieve these goals, we designed a controlled randomized pilot study that will be conducted within the Spanish Public Health System, where participating families will be randomly allocated to the intervention group (receiving the IY-ASLD® program) or to the treatment as usual condition (TAU) on a 1:1 ratio

Methods

Children in the care of their local authority

Findings

Discussion