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CompletedNCT02235467Updated Apr 2, 2015

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

A Phase 4 interventional study of ABA parent training in Autism Spectrum Disorders, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged 3 Years to 7 Years. Per ClinicalTrials.gov, last updated 2015-04-02.

Sponsored by Federal University of São Paulo · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
3 Years to 7 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Autism Spectrum Disorders

Keywords

  • autism
  • videomodeling
  • behavioral therapy
  • parental training
03

In context

Autistic Disorder

1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.

This study's enrollment of 67 is above the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
67 participants (actual)

Study arms

  • Active comparator
    ABA parent training

    Applied Behavior Analysis parent training using videomodeling in 21 sessions

    Behavioral: ABA parent training

  • No intervention
    ABA parent training control

Interventions

  • BehavioralABA parent training

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

    Also known as: Applied Behavior Analysis parent training using videomodeling

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline assessment to 8 weeks of therapy

  2. 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

    Time frame: baseline assessment to 16 weeks

  3. 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

    Time frame: baseline to 21 weeks

Secondary outcomes

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

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

    Time frame: baseline assessment to 21 weeks

  2. Change from baseline in Vineland Scale at 21 weeks

    Adaptative behavior using Vineland Scale

    Time frame: baseline assessment to 21 weeks

  3. 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

    Time frame: baseline assessment to 21 weeks

  4. 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

    Time frame: baseline assessment to 21 weeks

  5. 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.

    Time frame: baseline assessment to 21 weeks

Other outcomes

  1. Change from baseline in KAP at 21 weeks

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

    Time frame: baseline assessment to 21 weeks

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

    Improvement on the Hamilton Depression and Anxiety scales of the caregiver

    Time frame: baseline assessment to 21 weeks

07

Study locations

1 site
  • Federal University of São Paulo Department of Psychiatry
    São Paulo, 04038-030, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02235467
Lead sponsor
Federal University of São Paulo
Collaborators
Mackenzie Presbiterian University, São Paulo, Brazil, University of Sao Paulo
Responsible party
Jair Mari (MD, PhD, Federal University of São Paulo) — Principal investigator
First posted
Sep 10, 2014
Start date
Feb 2014
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Apr 2, 2015

Study contacts

Sheila C Caetano, MD, PhD
study director · Federal University of São Paulo, São Paulo, Brazil

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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