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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
- Source :
- Trials, Vol 22, Iss 1, Pp 1-10 (2021), Dipòsit Digital de la UB, Universidad de Barcelona, Trials
- Publication Year :
- 2021
- Publisher :
- Springer Nature, 2021.
-
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
- Subjects :
- 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
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Trials, Vol 22, Iss 1, Pp 1-10 (2021), Dipòsit Digital de la UB, Universidad de Barcelona, Trials
- Accession number :
- edsair.doi.dedup.....d4de24a4e64ba5e76aebcd24a0c23997