NCT02235467

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 2, 2015

Status Verified

March 1, 2015

Enrollment Period

10 months

First QC Date

September 5, 2014

Last Update Submit

March 31, 2015

Conditions

Autism Spectrum Disorders

Keywords

autismvideomodelingbehavioral therapyparental training

Outcome Measures

Primary Outcomes (3)

  • 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

    baseline assessment to 8 weeks of therapy

  • 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

    baseline assessment to 16 weeks

  • 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

    baseline to 21 weeks

Secondary Outcomes (5)

  • Change from baseline in Eye-tracking at 21 weeks

    baseline assessment to 21 weeks

  • Change from baseline in Vineland Scale at 21 weeks

    baseline assessment to 21 weeks

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

    baseline assessment to 21 weeks

  • Change from baseline in Zaritt Burden Interview at 21 weeks

    baseline assessment to 21 weeks

  • Change from baseline in OERA at 21 weeks

    baseline assessment to 21 weeks

Other Outcomes (2)

  • Change from baseline in KAP at 21 weeks

    baseline assessment to 21 weeks

  • Change from baseline in Hamilton scalels and at 21 weeks

    baseline assessment to 21 weeks

Study Arms (2)

ABA parent training

ACTIVE COMPARATOR

Applied Behavior Analysis parent training using videomodeling in 21 sessions

Behavioral: ABA parent training

ABA parent training control

NO INTERVENTION

Interventions

ABA parent trainingBEHAVIORAL

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
ABA parent training

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of São Paulo Department of Psychiatry

São Paulo, São Paulo, 04038-030, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 36808953DERIVED

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Sheila C Caetano, MD, PhD

    Federal University of São Paulo, São Paulo, Brazil

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 5, 2014

First Posted

September 10, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 2, 2015

Record last verified: 2015-03

Locations

BR(1)