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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorders
• Intervention / Treatment: Behavioral: ABA parent training

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ABA parent training; Applied Behavior Analysis parent training using videomodeling in 21 sessions	Behavioral: ABA parent training; 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
No Intervention: ABA parent training control

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in KAP at 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	Improvement on the Hamilton Depression and Anxiety scales of the caregiver	baseline assessment to 21 weeks

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: University of Sao Paulo; Mackenzie Presbiterian University, São Paulo, Brazil
• Investigators: Study Director: Sheila C Caetano, MD, PhD, Federal University of São Paulo, São Paulo, Brazil

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: September 5, 2014
• First Submitted That Met QC Criteria: September 5, 2014
• First Posted (Estimate): September 10, 2014

Study Record Updates

• Last Update Posted (Estimate): April 2, 2015
• Last Update Submitted That Met QC Criteria: March 31, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: autism; behavioral therapy; parental training; videomodeling
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: U1111-1157-8984; 2012/51584-0 (Other Grant/Funding Number: FAPESP)