Clinical trial NCT02235467: Multisite Study: Parental Training Using Video Modelling to Develop Social Skills in Children With Autism
Official title: Multisite Study: Acquisition of Social Skills in Children With Autism Using Video Modeling in Parental Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Autism Spectrum Disorders
Keywords: autism
videomodeling
behavioral therapy
parental training
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Mackenzie Presbiterian University, São Paulo, Brazil
name: University of Sao Paulo
First posted: 2014-09-10
Enrollment: 67
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acquisition from baseline of new behaviors at 8 weeks
timeFrame: baseline assessment to 8 weeks of therapy
measure: Acquisition from baseline of new behaviors at 16 weeks
timeFrame: baseline assessment to 16 weeks
measure: Acquisition from baseline of new behaviors at 21 weeks
timeFrame: baseline to 21 weeks
Secondary outcomes:
measure: Change from baseline in Eye-tracking at 21 weeks
timeFrame: baseline assessment to 21 weeks
measure: Change from baseline in Vineland Scale at 21 weeks
timeFrame: baseline assessment to 21 weeks
measure: Change from baseline in SON-R 2½-7 at 21 weeks
timeFrame: baseline assessment to 21 weeks
measure: Change from baseline in Zaritt Burden Interview at 21 weeks
timeFrame: baseline assessment to 21 weeks
measure: Change from baseline in OERA at 21 weeks
timeFrame: baseline assessment to 21 weeks
Other outcomes:
measure: Change from baseline in KAP at 21 weeks
timeFrame: baseline assessment to 21 weeks
measure: Change from baseline in Hamilton scalels and at 21 weeks
timeFrame: baseline assessment to 21 weeks
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo Department of Psychiatry
Study officials:
affiliation: Federal University of São Paulo, São Paulo, Brazil
name: Sheila C Caetano, MD, PhD
role: STUDY_DIRECTOR
References: