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

31. mars 2015 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

67

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

3 år til 7 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: ABA parent training
Applied Behavior Analysis parent training using videomodeling in 21 sessions
Atferdsmessig: ABA parent training
A parent training based on Applied Behavior Analysis that is going to be delivered by video modeling in 21 weeks
Andre navn:
  • Applied Behavior Analysis parent training using videomodeling
Ingen inngripen: ABA parent training control

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Acquisition from baseline of new behaviors at 8 weeks
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline in Eye-tracking at 21 weeks
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline in KAP at 21 weeks
Tidsramme: 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
Tidsramme: baseline assessment to 21 weeks
Improvement on the Hamilton Depression and Anxiety scales of the caregiver
baseline assessment to 21 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Federal University of São Paulo

Samarbeidspartnere

University of Sao Paulo
Mackenzie Presbiterian University, São Paulo, Brazil

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2014

Primær fullføring (Faktiske)

1. desember 2014

Studiet fullført (Faktiske)

1. desember 2014

Datoer for studieregistrering

Først innsendt

5. september 2014

Først innsendt som oppfylte QC-kriteriene

5. september 2014

Først lagt ut (Anslag)

10. september 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

2. april 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. mars 2015

Sist bekreftet

1. mars 2015

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • U1111-1157-8984
  • 2012/51584-0 (Annet stipend/finansieringsnummer: FAPESP)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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