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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Autism Spectrum Disorders

Intervention / Treatment
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* Behavioral: ABA parent training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ABA parent training<br>Applied Behavior Analysis parent training using videomodeling in 21 sessions | Behavioral: ABA parent training<br>* A parent training based on Applied Behavior Analysis that is going to be delivered by video modeling in 21 weeks<br>* Other names: Applied Behavior Analysis parent training using videomodeling;|
| No Intervention: ABA parent training control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acquisition from baseline of new behaviors at 8 weeks | 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 | 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 | acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member | baseline to 21 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Eye-tracking at 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 | Adaptative behavior using Vineland Scale | baseline assessment to 21 weeks | 
| Change from baseline in SON-R 2½-7 at 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autism, videomodeling, behavioral therapy, parental training