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ArticleTrials2021

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.

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

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.3field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04358484 naunknown statusnot on this map

Protocol for a Randomized Pilot Study (FIRST STEPS): Implementation of the Incredible Years-ASLD® Program in Spanish Preschoolers With Autism and Premature Children With Communication or Socialization Difficulties

TypeinterventionalSponsorFundació Sant Joan de DéuRan2020 to 2021Enrolled72ConditionsAutism Spectrum Disorder, Language Delay, PrematurityArmsIncredible Years - ASD and Language Delay®
NCT06125093 nacompletednot on this mapstarted 2023, after this paper: background citation

Early Treatment for Children With Mental Health Problems and Genetic Abnormalities Through a Parenting Intervention (The GAP): A Pragmatic Randomized Controlled Trial

TypeinterventionalSponsorFundació Sant Joan de DéuRan2023 to 2024Enrolled53ConditionsGenetic Syndrome, Language Development, Autism or Autistic Traits, ParentingArmsIncredible Years Autism Spectrum and Language Delays Parent Program (IY-ASLD®)
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Fátima ValenciaDepartment of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Elena UrbiolaDepartment of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Marina Romero-GonzálezMaternity Hospital, Hospital Regional Universitario de Málaga, Málaga, Spain. marinarglez@gmail.com.ORCID http://orcid.org/0000-0003-4842-821X
Inmaculada NavasMaternity Hospital, Hospital Regional Universitario de Málaga, Málaga, Spain.
María ElíasDepartment of Psychiatry and Psychology, Hospital Sant Joan de Déu de Barcelona, L'Hospitalet de Llobregat, Spain.
Alexandra GarrizDepartment of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Almudena RamírezMaternity Hospital, Hospital Regional Universitario de Málaga, Málaga, Spain.
Laia VillaltaDepartment of Psychiatry and Psychology, Hospital Sant Joan de Déu de Barcelona, L'Hospitalet de Llobregat, Spain.
Hospital General Universitario Gregorio Marañón · ESHospital Regional Universitario de Málaga · ESHospital Sant Joan de Déu Barcelona · ES

Funding

CSRD VA 1
6 · The paper itself

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.

Indexed as

Autism Spectrum DisorderAutistic DisorderCommunicationSocializationChildChild, PreschoolHumansMulticenter Studies as TopicParentingParentsPilot ProjectsPremature BirthRandomized Controlled Trials as TopicSpainASDChild developmentComplex interventionParenting interventionPilotPreterm childrenrandomized controlled trial

Identifiers

PMID33879224
PMCPMC8056105
OpenAlexW3106675206

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.