Autism Spectrum DisorderNCT02360449
Social Motivation Intervention for Children With Autism Spectrum Disorder: Improving Peer Initiation
A study testing Social Initiation Motivation Intervention in people with Autism Spectrum Disorder, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether a social initiation motivation intervention (SIMI) focused on training children with ASD to initiate to peers during structured play activities will result in more frequent initiations to typically developing peers during free play. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Social Initiation Motivation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 5 Nov 2020
- Phase
- Interventional
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age 4.0 to 6.11 years;
- diagnosis of Autism Spectrum Disorder
- without intellectual disability
- stable community treatments four weeks before and throughout the trial.
Who cannot join
- diagnosed severe psychiatric or genetic disorder or medical problem;
- severe disruptive behavior that would interfere with peer interactions
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate whether a social initiation motivation intervention (SIMI) focused on training children with ASD to initiate to peers during structured play activities will result in more frequent initiations to typically developing peers during free play. The SIMI approach under investigation uses behavioral strategies based in Applied Behavior Analysis and Pivotal Response Treatment to motivate children with ASD to initiate to peers. Children with ASD will be randomly assigned to either the SIMI or a waiting list. Treatment will be provided for 8 weeks in the context of a weekly social skills group.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Social Initiation Motivation Intervention
- Keywords
- Pivotal Response Treatment, Applied Behavior Analysis, Peer Initiation, Social Skills Group
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Initiation Motivation InterventionBehavioural
Also called Pivotal Response Treatment
The SIMI approach under investigation uses behavioral strategies based in Applied Behavior Analysis and Pivotal Response Treatment to motivate children with ASD to initiate to peers. The adult arranges the play environment in order to promote cooperation and facilitates frequent prompting and reinforcement from peers, thereby enhancing the reward value of peer interactions.
| Study group | Role | What they receive |
|---|---|---|
| Wait List | No intervention | Not described |
| Social Initiation Motivation Intervention | Experimental | Not described Receives: Behavioral: Social Initiation Motivation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation Frequency (observational rating of the frequency of child initiations to peers measured from video recording during free play sessions)
The primary measure is an observational rating of the frequency of child initiations to peers measured from video recording during free play sessions at baseline and post-treatment.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startJan 2015
- Primary completion19 Jul 2017
- Study completion5 Nov 2020
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 DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grace Gengoux, Stanford University
- Investigators
- Grace Gengoux, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360449
- Sponsor's protocol ID
- 31420
- Status last verified
- Jan 2021
- First submitted
- 5 Feb 2015
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Gengoux GW, Schwartzman JM, Millan ME, Schuck RK, Ruiz AA, Weng Y, Long J, Hardan AY. Enhancing Social Initiations Using Naturalistic Behavioral Intervention: Outcomes from a Randomized Controlled Trial for Children with Autism. J Autism Dev Disord. 2021 Oct;51(10):3547-3563. doi: 10.1007/s10803-020-04787-8. Epub 2021 Jan 2.
PubMed 33387236
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Motivation Intervention for Children With Autism Spectrum Disorder: Improving Peer Initiation
- ClinicalTrials.gov ID
- NCT02360449
- Acronym / sponsor ID
- 31420
- Conditions
- Autism Spectrum Disorder
- Keywords
- Pivotal Response Treatment, Applied Behavior Analysis, Peer Initiation, Social Skills Group
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 19 Jul 2017 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 10 Feb 2015 (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.
The purpose of this study is to investigate whether a social initiation motivation intervention (SIMI) focused on training children with ASD to initiate to peers during structured play activities will result in more frequent initiations to typically developing peers during free play. The SIMI approach under investigation uses behavioral strategies based in Applied Behavior Analysis and Pivotal Response Treatment to motivate children with ASD to initiate to peers. Children with ASD will be randomly assigned to either the SIMI or a waiting list. Treatment will be provided for 8 weeks in the context of a weekly social skills group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait List | No intervention | – |
| Social Initiation Motivation Intervention | Experimental | Behavioral: Social Initiation Motivation Intervention |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- age 4.0 to 6.11 years;
- diagnosis of Autism Spectrum Disorder
- without intellectual disability
- stable community treatments four weeks before and throughout the trial.
Key exclusion criteria (2 listed)
- diagnosed severe psychiatric or genetic disorder or medical problem;
- severe disruptive behavior that would interfere with peer interactions
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 |
|---|---|---|
| Social Initiation Motivation InterventionAlso: Pivotal Response TreatmentThe SIMI approach under investigation uses behavioral strategies based in Applied Behavior Analysis and Pivotal Response Treatment to motivate children with ASD to initiate to peers. The adult arranges the play environment in order to promote cooperation and facilitates frequent prompting and reinforcement from peers, thereby enhancing the reward value of peer interactions. | Behavioural | Social Initiation Motivation Intervention |
Primary outcome
Initiation Frequency (observational rating of the frequency of child initiations to peers measured from video recording during free play sessions)
Time frame: 8 weeks
The primary measure is an observational rating of the frequency of child initiations to peers measured from video recording during free play sessions at baseline and post-treatment.
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 8 Jan 2021.
- Results publication: PubMed 33387236Gengoux GW, Schwartzman JM, Millan ME, Schuck RK, Ruiz AA, Weng Y, Long J, Hardan AY. Enhancing Social Initiations Using Naturalistic Behavioral Intervention: Outcomes from a Randomized Controlled Trial for Children with Autism. J Autism Dev Disord. 2021 Oct;51(10):3547-3563. doi: 10.1007/s10803-020-04787-8. Epub 2021 Jan 2.
- Published primary trial results (Stanford Medical Library link)Link provided by the sponsor.
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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.
Grace Gengoux, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Initiation Motivation Intervention in people with Autism Spectrum Disorder, run by Stanford University at 1 site in United States.
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 2 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 8 Jan 2021. 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 United States. 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.
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?
Initiation Frequency (observational rating of the frequency of child initiations to peers measured from video recording during free play sessions) (time frame: 8 weeks). 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 NCT02360449, 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 8 Jan 2021.