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

Primary Purpose

Autism Spectrum Disorders

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

ABA parent training

About this trial

This is an interventional treatment trial for Autism Spectrum Disorders focused on measuring autism, videomodeling, behavioral therapy, parental training

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Federal University of São Paulo Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

ABA parent training

ABA parent training control

Arm Description

Applied Behavior Analysis parent training using videomodeling in 21 sessions

Outcomes

Primary Outcome Measures

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

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

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

Secondary Outcome Measures

Change from baseline in Eye-tracking at 21 weeks

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

Change from baseline in Vineland Scale at 21 weeks

Adaptative behavior using Vineland Scale

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

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

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.

Full Information

NCT ID

NCT02235467

First Posted

September 5, 2014

Last Updated

March 31, 2015

Sponsor

Federal University of São Paulo

Collaborators

Mackenzie Presbiterian University, São Paulo, Brazil, University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT02235467

Brief Title

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

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of São Paulo

Collaborators

Mackenzie Presbiterian University, São Paulo, Brazil, University of Sao Paulo

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorders

Keywords

autism, videomodeling, behavioral therapy, parental training

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ABA parent training

Arm Type

Active Comparator

Arm Description

Applied Behavior Analysis parent training using videomodeling in 21 sessions

Arm Title

ABA parent training control

Arm Type

No Intervention

Intervention Type

Behavioral

Intervention Name(s)

ABA parent training

Other Intervention Name(s)

Applied Behavior Analysis parent training using videomodeling

Intervention Description

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

Primary Outcome Measure Information:

Title

Acquisition from baseline of new behaviors at 8 weeks

Description

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

Title

Acquisition from baseline of new behaviors at 16 weeks

Description

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

Title

Acquisition from baseline of new behaviors at 21 weeks

Description

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 Outcome Measure Information:

Title

Change from baseline in Eye-tracking at 21 weeks

Description

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

Time Frame

baseline assessment to 21 weeks

Title

Change from baseline in Vineland Scale at 21 weeks

Description

Adaptative behavior using Vineland Scale

Time Frame

baseline assessment to 21 weeks

Title

Change from baseline in SON-R 2½-7 at 21 weeks

Description

Improve on SON-R 2½-7 that is an intelligence coefficient test developed for deaf people

Time Frame

baseline assessment to 21 weeks

Title

Change from baseline in Zaritt Burden Interview at 21 weeks

Description

The Zaritt Burden Interview measures the caregiver burden of taking care of the relative with psychiatric disorder

Time Frame

baseline assessment to 21 weeks

Title

Change from baseline in OERA at 21 weeks

Description

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 Pre-specified Outcome Measures:

Title

Change from baseline in KAP at 21 weeks

Description

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

Time Frame

baseline assessment to 21 weeks

Title

Change from baseline in Hamilton scalels and at 21 weeks

Description

Improvement on the Hamilton Depression and Anxiety scales of the caregiver

Time Frame

baseline assessment to 21 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sheila C Caetano, MD, PhD

Organizational Affiliation

Federal University of São Paulo, São Paulo, Brazil

Official's Role

Study Director

Facility Information:

Facility Name

Federal University of São Paulo Department of Psychiatry

City

São Paulo

ZIP/Postal Code

04038-030

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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