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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 April 2015
• Main ID: NCT02235467
• Date of registration: 05/09/2014
• Prospective Registration: No
• Primary sponsor: Federal University of São Paulo
• Public title: Multisite Study: Parental Training Using Video Modelling to Develop Social Skills in Children With Autism
• Scientific title: Multisite Study: Acquisition of Social Skills in Children With Autism Using Video Modeling in Parental Training
• Date of first enrolment: February 2014
• Target sample size: 67
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02235467
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Brazil

Contacts

• Name: Sheila C Caetano, MD, PhD
• Affiliation: Federal University of São Paulo, São Paulo, Brazil

Key inclusion & exclusion 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



Age minimum: 3 Years
Age maximum: 7 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Autism Spectrum Disorders

Intervention(s)

Behavioral: ABA parent training

Primary Outcome(s)

Acquisition from baseline of new behaviors at 16 weeks [Time Frame: baseline assessment to 16 weeks]

Acquisition from baseline of new behaviors at 21 weeks [Time Frame: baseline to 21 weeks]

Acquisition from baseline of new behaviors at 8 weeks [Time Frame: baseline assessment to 8 weeks of therapy]

Secondary Outcome(s)

Change from baseline in SON-R 2½-7 at 21 weeks [Time Frame: baseline assessment to 21 weeks]

Change from baseline in OERA at 21 weeks [Time Frame: baseline assessment to 21 weeks]

Change from baseline in Vineland Scale at 21 weeks [Time Frame: baseline assessment to 21 weeks]

Change from baseline in Zaritt Burden Interview at 21 weeks [Time Frame: baseline assessment to 21 weeks]

Change from baseline in Eye-tracking at 21 weeks [Time Frame: baseline assessment to 21 weeks]

Secondary ID(s)

2012/51584-0

U1111-1157-8984

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Sao Paulo

Mackenzie Presbiterian University, São Paulo, Brazil