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

Autism Spectrum Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02235467
• Other study ID #: U1111-1157-8984
• Secondary ID: 2012/51584-0
• Status: Completed
• Phase: Phase 4
• First received: September 5, 2014
• Last updated: March 31, 2015
• Start date: February 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 7 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorders
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

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

Locations

Country	Name	City	State
Brazil	Federal University of São Paulo Department of Psychiatry	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of São Paulo	Mackenzie Presbiterian University, São Paulo, Brazil, University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in KAP at 21 weeks	Improvement on the knowledge, attitude and practice (KAP) questionnaire	baseline assessment to 21 weeks	No
Other	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Change from baseline in Vineland Scale at 21 weeks	Adaptative behavior using Vineland Scale	baseline assessment to 21 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No