CClinicalTrials.gg
CompletedNCT02360449Updated Jan 8, 2021

Social Motivation Intervention for Children With Autism Spectrum Disorder: Improving Peer Initiation

An interventional study of Social Initiation Motivation Intervention in Autism Spectrum Disorder, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 4 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-08.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
4 Years to 6 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Autism Spectrum Disorder

Keywords

  • Pivotal Response Treatment
  • Applied Behavior Analysis
  • Peer Initiation
  • Social Skills Group
03

In context

Autistic Disorder

1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.

This study's enrollment of 44 is close to the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. age 4.0 to 6.11 years;
  2. diagnosis of Autism Spectrum Disorder
  3. without intellectual disability
  4. stable community treatments four weeks before and throughout the trial.

Exclusion criteria

Exclusion criteria:

  1. diagnosed severe psychiatric or genetic disorder or medical problem;
  2. severe disruptive behavior that would interfere with peer interactions
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
44 participants (actual)

Study arms

  • No intervention
    Wait List
  • Experimental
    Social Initiation Motivation Intervention

    Behavioral: Social Initiation Motivation Intervention

Interventions

  • BehavioralSocial Initiation Motivation Intervention

    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.

    Also known as: Pivotal Response Treatment

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks

07

Study locations

1 site
  • Stanford University
    Stanford, California 94305, United States
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02360449
Lead sponsor
Stanford University
Responsible party
Grace Gengoux (Clinical Assistant Professor, Stanford University) — Principal investigator
First posted
Feb 10, 2015
Start date
Jan 2015
Primary completion
Jul 19, 2017
Completion
Nov 5, 2020
Last update
Jan 8, 2021

Study contacts

Grace Gengoux, PhD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion