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Completed

NCT Number: NCT02235467

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

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.

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Key information

Conditions

Autism Spectrum Disorders Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Federal University of São Paulo Department of Psychiatry

São Paulo, 04038-030, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABA parent training

Behavioral

A parent training based on Applied Behavior Analysis that is going to be delivered by video modeling in 21 weeks

Other names: Applied Behavior Analysis parent training using videomodeling

Primary outcomes

  1. Acquisition from baseline of new behaviors at 8 weeks

    Time frame: 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

  2. Acquisition from baseline of new behaviors at 16 weeks

    Time frame: baseline assessment to 16 weeks

    acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member

  3. Acquisition from baseline of new behaviors at 21 weeks

    Time frame: baseline to 21 weeks

    acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member

Secondary outcomes

  1. Change from baseline in Eye-tracking at 21 weeks

    Time frame: baseline assessment to 21 weeks

    Latency, duration, and sequence of visual fixations measured with eye-tracking

  2. Change from baseline in Vineland Scale at 21 weeks

    Time frame: baseline assessment to 21 weeks

    Adaptative behavior using Vineland Scale

  3. Change from baseline in SON-R 2½-7 at 21 weeks

    Time frame: baseline assessment to 21 weeks

    Improve on SON-R 2½-7 that is an intelligence coefficient test developed for deaf people

  4. Change from baseline in Zaritt Burden Interview at 21 weeks

    Time frame: baseline assessment to 21 weeks

    The Zaritt Burden Interview measures the caregiver burden of taking care of the relative with psychiatric disorder

  5. Change from baseline in OERA at 21 weeks

    Time frame: 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.

Other outcomes

  1. Change from baseline in KAP at 21 weeks

    Time frame: baseline assessment to 21 weeks

    Improvement on the knowledge, attitude and practice (KAP) questionnaire

  2. Change from baseline in Hamilton scalels and at 21 weeks

    Time frame: baseline assessment to 21 weeks

    Improvement on the Hamilton Depression and Anxiety scales of the caregiver

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 10, 2014
Registry last updated
Apr 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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