1. 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
- Author
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Fátima Valencia, Inmaculada Navas, Maria Elias, Laia Villalta, Marina Romero-González, Almudena Ramírez, Alexandra Garriz, Elena Urbiola, [Valencia,F, Urbiola,E, Garriz,A] Department of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, Madrid, Spain. [Romero-González,M, Navas,I, Ramírez,A] Maternity Hospital, Hospital Regional Universitario de Málaga, Málaga, Spain. [Romero-González,M, Ramírez,A] Department of Brain Health, CIMES, Faculty of Medicine-IBIMA, UMA, Málaga, Spain. [Elías,M, Villalta,L] Department of Psychiatry and Psychology, Hospital Sant Joan de Déu de Barcelona, L’Hospitalet de Llobregat, Spain. [Villalta,L] Children and Adolescent Mental Health Research Group, Research Institute Sant Joan de Déu, Esplugues de Llobregat, Spain., and This paper reports on independent research financially supported by the Alicia Koplowitz Foundation.
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Parents ,Medicine (General) ,Information Science::Information Science::Communication [Medical Subject Headings] ,Autism Spectrum Disorder ,Psychiatry and Psychology::Behavior and Behavior Mechanisms::Psychology, Social::Family::Family Relations::Parenting [Medical Subject Headings] ,Psychological intervention ,Medicine (miscellaneous) ,Pilot Projects ,law.invention ,Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings] ,Study Protocol ,0302 clinical medicine ,Randomized controlled trial ,Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Clinical Trials as Topic::Multicenter Studies as Topic [Medical Subject Headings] ,law ,Autistic children ,Medicine ,Multicenter Studies as Topic ,Pharmacology (medical) ,Child ,Child development ,Randomized Controlled Trials as Topic ,Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Clinical Trials as Topic::Controlled Clinical Trials as Topic::Randomized Controlled Trials as Topic [Medical Subject Headings] ,Parenting ,Communication ,05 social sciences ,Pilot ,Autism spectrum disorder ,Child, Preschool ,Premature Birth ,050104 developmental & child psychology ,Clinical psychology ,medicine.medical_specialty ,Parenting intervention ,Pilotos ,Psychiatry and Psychology::Mental Disorders::Mental Disorders Diagnosed in Childhood::Child Development Disorders, Pervasive::Autistic Disorder [Medical Subject Headings] ,ASD ,Desarrollo infantil ,03 medical and health sciences ,R5-920 ,Complex intervention ,Intervention (counseling) ,Humans ,0501 psychology and cognitive sciences ,Persons::Persons::Age Groups::Child [Medical Subject Headings] ,Autistic Disorder ,Geographical Locations::Geographic Locations::Europe::Spain [Medical Subject Headings] ,Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Pilot Projects [Medical Subject Headings] ,Infants autistes ,business.industry ,Public health ,Trastorno del espectro del autismo ,Socialization ,medicine.disease ,Mental health ,Responsabilidad parental ,Desenvolupament infantil ,Preterm children ,Spain ,randomized controlled trial ,Autism ,Anthropology, Education, Sociology and Social Phenomena::Social Sciences::Sociology::Socialization [Medical Subject Headings] ,Diseases::Female Urogenital Diseases and Pregnancy Complications::Pregnancy Complications::Obstetric Labor Complications::Obstetric Labor, Premature::Premature Birth [Medical Subject Headings] ,business ,Persons::Persons::Parents [Medical Subject Headings] ,Persons::Persons::Age Groups::Child::Child, Preschool [Medical Subject Headings] ,030217 neurology & neurosurgery ,Nacimiento prematuro - Abstract
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 registration ClinicalTrials.gov NCT04358484. Registered on 04 April 2020
- Published
- 2021