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

NCT ID: NCT02235467

Last Updated: 2015-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Autism Spectrum Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ABA parent training

Applied Behavior Analysis parent training using videomodeling in 21 sessions

Group Type ACTIVE_COMPARATOR

ABA parent training

Intervention Type BEHAVIORAL

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

ABA parent training control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ABA parent training

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Applied Behavior Analysis parent training using videomodeling

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mackenzie Presbiterian University, São Paulo, Brazil

OTHER

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Jair Mari

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sheila C Caetano, MD, PhD

Role: STUDY_DIRECTOR

Federal University of São Paulo, São Paulo, Brazil

Locations

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Federal University of São Paulo Department of Psychiatry

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Correia BSB, de Moraes Pontes JG, Nani JVS, Villalta F, Mor NC, Bordini D, Brunoni D, Brentani H, Mari JJ, Hayashi MAF, Tasic L. 1H NMR Metabolomics and Lipidomics To Monitor Positive Responses in Children with Autism Spectrum Disorder Following a Guided Parental Intervention: A Pilot Study. ACS Chem Neurosci. 2023 Mar 15;14(6):1137-1145. doi: 10.1021/acschemneuro.2c00735. Epub 2023 Feb 21.

Reference Type DERIVED
PMID: 36808953 (View on PubMed)

Other Identifiers

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2012/51584-0

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

U1111-1157-8984

Identifier Type: -

Identifier Source: org_study_id

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