Autism Spectrum DisordersPhase 4NCT02235467
Multisite Study: Parental Training Using Video Modelling to Develop Social Skills in Children With Autism
A Phase 4 study testing ABA parent training in people with Autism Spectrum Disorders, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- ABA parent training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2014to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of São Paulo Department of Psychiatry
São Paulo, São Paulo, 04038-030
About this study
Official title: Multisite Study: Acquisition of Social Skills in Children With Autism Using Video Modeling in Parental Training
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.
Read the 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.
- Conditions
- Autism Spectrum Disorders
- Being tested
- ABA parent training
- Keywords
- autism, videomodeling, behavioral therapy, parental training
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABA parent trainingBehavioural
Also called Applied Behavior Analysis parent training using videomodeling
A parent training based on Applied Behavior Analysis that is going to be delivered by video modeling in 21 weeks
| Study group | Role | What they receive |
|---|---|---|
| ABA parent training | Active comparator | Applied Behavior Analysis parent training using videomodeling in 21 sessions Receives: Behavioral: ABA parent training |
| ABA parent training control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: baseline to 21 weeks
Secondary outcomes (5)
Change from baseline in Eye-tracking at 21 weeks
Latency, duration, and sequence of visual fixations measured with eye-tracking
Measured: baseline assessment to 21 weeks
Change from baseline in Vineland Scale at 21 weeks
Adaptative behavior using Vineland Scale
Measured: baseline assessment to 21 weeks
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
Measured: baseline assessment to 21 weeks
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
Measured: baseline assessment to 21 weeks
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.
Measured: baseline assessment to 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Mackenzie Presbiterian University, São Paulo, Brazil, University of Sao Paulo
- Responsible party
- Principal investigator, Jair Mari, Federal University of São Paulo
- Investigators
- Sheila C Caetano, MD, PhD, Study director, Federal University of São Paulo, São Paulo, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235467
- Sponsor's protocol ID
- U1111-1157-8984
- Other IDs
- 2012/51584-0
- Status last verified
- Mar 2015
- First submitted
- 5 Sep 2014
- Last updated
- 2 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36808953
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisite Study: Acquisition of Social Skills in Children With Autism Using Video Modeling in Parental Training
- ClinicalTrials.gov ID
- NCT02235467
- Acronym / sponsor ID
- U1111-1157-8984
- Conditions
- Autism Spectrum Disorders
- Keywords
- autism, videomodeling, behavioral therapy, parental training
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Mackenzie Presbiterian University, São Paulo, Brazil, University of Sao Paulo
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABA parent training | Active comparator | Behavioral: ABA parent trainingApplied Behavior Analysis parent training using videomodeling in 21 sessions |
| ABA parent training control | No intervention | – |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABA parent trainingAlso: Applied Behavior Analysis parent training using videomodelingA parent training based on Applied Behavior Analysis that is going to be delivered by video modeling in 21 weeks | Behavioural | ABA parent training |
Primary outcome
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
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
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
5 secondary outcomes
Change from baseline in Eye-tracking 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 SON-R 2½-7 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 OERA at 21 weeks
Time frame: baseline assessment to 21 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2015.
- Derived from this study: PubMed 36808953Correia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheila C Caetano, MD, PhD study director
Federal University of São Paulo, São Paulo, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ABA parent training in people with Autism Spectrum Disorders, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acquisition from baseline of new behaviors at 8 weeks (time frame: baseline assessment to 8 weeks of therapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02235467, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2015.