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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02235467
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : April 2, 2015
Sponsor:
Collaborators:
Mackenzie Presbiterian University, São Paulo, Brazil
University of Sao Paulo
Information provided by (Responsible Party):
Jair Mari, Federal University of São Paulo

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.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Behavioral: ABA parent training Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multisite Study: Acquisition of Social Skills in Children With Autism Using Video Modeling in Parental Training
Study Start Date : February 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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 Name: Applied Behavior Analysis parent training using videomodeling

No Intervention: ABA parent training control



Primary Outcome Measures :
  1. Acquisition from baseline of new behaviors at 8 weeks [ Time Frame: baseline assessment to 8 weeks of therapy ]
    acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member

  2. Acquisition from baseline of new behaviors at 16 weeks [ Time Frame: baseline assessment to 16 weeks ]
    acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member

  3. Acquisition from baseline of new behaviors at 21 weeks [ Time Frame: baseline to 21 weeks ]
    acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member


Secondary Outcome Measures :
  1. Change from baseline in Eye-tracking at 21 weeks [ Time Frame: baseline assessment to 21 weeks ]
    Latency, duration, and sequence of visual fixations measured with eye-tracking

  2. Change from baseline in Vineland Scale at 21 weeks [ Time Frame: baseline assessment to 21 weeks ]
    Adaptative behavior using Vineland Scale

  3. Change from baseline in SON-R 2½-7 at 21 weeks [ Time Frame: baseline assessment to 21 weeks ]
    Improve on SON-R 2½-7 that is an intelligence coefficient test developed for deaf people

  4. Change from baseline in Zaritt Burden Interview at 21 weeks [ Time Frame: baseline assessment to 21 weeks ]
    The Zaritt Burden Interview measures the caregiver burden of taking care of the relative with psychiatric disorder

  5. Change from baseline in OERA at 21 weeks [ Time Frame: baseline assessment to 21 weeks ]
    OERA (Observação Estruturada para Rastreamento de Autismo) is a taped structured observation to screen Autism that was developed by Brazilian researchers.


Other Outcome Measures:
  1. Change from baseline in KAP at 21 weeks [ Time Frame: baseline assessment to 21 weeks ]
    Improvement on the knowledge, attitude and practice (KAP) questionnaire

  2. Change from baseline in Hamilton scalels and at 21 weeks [ Time Frame: baseline assessment to 21 weeks ]
    Improvement on the Hamilton Depression and Anxiety scales of the caregiver



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235467


Locations
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Brazil
Federal University of São Paulo Department of Psychiatry
São Paulo, Brazil, 04038-030
Sponsors and Collaborators
Federal University of São Paulo
Mackenzie Presbiterian University, São Paulo, Brazil
University of Sao Paulo
Investigators
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Study Director: Sheila C Caetano, MD, PhD Federal University of São Paulo, São Paulo, Brazil
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Responsible Party: Jair Mari, MD, PhD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02235467    
Other Study ID Numbers: U1111-1157-8984
2012/51584-0 ( Other Grant/Funding Number: FAPESP )
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: April 2, 2015
Last Verified: March 2015
Keywords provided by Jair Mari, Federal University of São Paulo:
autism
videomodeling
behavioral therapy
parental training
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders