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Multisite Study: Parental Training Using Video Modelling to Develop Social Skills in Children With Autism

31 mars 2015 uppdaterad av: Jair Mari, Federal University of São Paulo

Multisite Study: Acquisition of Social Skills in Children With Autism Using Video Modeling in Parental Training

This is a Brazilian multisite study to test the efficacy of an Applied Behavior Analysis (ABA) parent training using video modeling to teach parents of children with Autism techniques to apply to their children in order to improve eye contact and joint attention behaviors.

Our hypothesis is that children with Autism whose parents will be trained by videomodeling will have better eye contact and joint attention behaviors compared to children with Autism whose parents will not be trained.

Studieöversikt

Status

Avslutad

Intervention / Behandling

Detaljerad beskrivning

Applied Behavior Analysis (ABA) is an intervention with proven efficacy in treating impairments on social functioning and daily-life activities of individuals with Autism Spectrum Disorder (ASD). In Brazil we have a limited number of qualified professionals and an increasing demand of families non-served in the public health system.

Our main objective is to standardize and test the efficacy of a model for parent training using video modeling for teaching eye contact and joint attention behaviors in children with ASD. These two behaviors are essential to develop adequate social interaction, the core impaired domain in ASD. It is a multisite study to be carried out at the Universidade Federal de São Paulo, Universidade de São Paulo and Universidade Presbiteriana Mackenzie. The sample will be composed of 70 children divided in control and intervention groups that will be randomly chosen. The intervention should be carried out in 21 weeks.

Studietyp

Interventionell

Inskrivning (Faktisk)

67

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • São Paulo, Brasilien, 04038-030
        • Federal University of São Paulo Department of Psychiatry

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

3 år till 7 år (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Clinical Diagnosis of Autism Spectrum Disorders
  • Diagnosis of Autism Spectrum Disorders by means of ADI
  • IQ equal or lower than 70 by means of SON
  • Main caregiver's level of education > primary education

Exclusion Criteria:

  • IQ lower than 50 by means of SON
  • Child who is receiving ABA therapy at least 10 hours per week
  • Main caregiver diagnosed with Autism Spectrum Disorders

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: ABA parent training
Applied Behavior Analysis parent training using videomodeling in 21 sessions
A parent training based on Applied Behavior Analysis that is going to be delivered by video modeling in 21 weeks
Andra namn:
  • Applied Behavior Analysis parent training using videomodeling
Inget ingripande: ABA parent training control

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Acquisition from baseline of new behaviors at 8 weeks
Tidsram: baseline assessment to 8 weeks of therapy
acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member
baseline assessment to 8 weeks of therapy
Acquisition from baseline of new behaviors at 16 weeks
Tidsram: baseline assessment to 16 weeks
acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member
baseline assessment to 16 weeks
Acquisition from baseline of new behaviors at 21 weeks
Tidsram: baseline to 21 weeks
acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member
baseline to 21 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from baseline in Eye-tracking at 21 weeks
Tidsram: baseline assessment to 21 weeks
Latency, duration, and sequence of visual fixations measured with eye-tracking
baseline assessment to 21 weeks
Change from baseline in Vineland Scale at 21 weeks
Tidsram: baseline assessment to 21 weeks
Adaptative behavior using Vineland Scale
baseline assessment to 21 weeks
Change from baseline in SON-R 2½-7 at 21 weeks
Tidsram: baseline assessment to 21 weeks
Improve on SON-R 2½-7 that is an intelligence coefficient test developed for deaf people
baseline assessment to 21 weeks
Change from baseline in Zaritt Burden Interview at 21 weeks
Tidsram: baseline assessment to 21 weeks
The Zaritt Burden Interview measures the caregiver burden of taking care of the relative with psychiatric disorder
baseline assessment to 21 weeks
Change from baseline in OERA at 21 weeks
Tidsram: baseline assessment to 21 weeks
OERA (Observação Estruturada para Rastreamento de Autismo) is a taped structured observation to screen Autism that was developed by Brazilian researchers.
baseline assessment to 21 weeks

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from baseline in KAP at 21 weeks
Tidsram: baseline assessment to 21 weeks
Improvement on the knowledge, attitude and practice (KAP) questionnaire
baseline assessment to 21 weeks
Change from baseline in Hamilton scalels and at 21 weeks
Tidsram: baseline assessment to 21 weeks
Improvement on the Hamilton Depression and Anxiety scales of the caregiver
baseline assessment to 21 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Studierektor: Sheila C Caetano, MD, PhD, Federal University of São Paulo, São Paulo, Brazil

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 februari 2014

Primärt slutförande (Faktisk)

1 december 2014

Avslutad studie (Faktisk)

1 december 2014

Studieregistreringsdatum

Först inskickad

5 september 2014

Först inskickad som uppfyllde QC-kriterierna

5 september 2014

Första postat (Uppskatta)

10 september 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

2 april 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 mars 2015

Senast verifierad

1 mars 2015

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • U1111-1157-8984
  • 2012/51584-0 (Annat bidrag/finansieringsnummer: FAPESP)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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