NCT02360449

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2017

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2020

Completed
Last Updated

January 8, 2021

Status Verified

January 1, 2021

Enrollment Period

2.5 years

First QC Date

February 5, 2015

Last Update Submit

January 6, 2021

Conditions

Autism Spectrum Disorder

Keywords

Pivotal Response TreatmentApplied Behavior AnalysisPeer InitiationSocial Skills Group

Outcome Measures

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.

    8 weeks

Study Arms (2)

Wait List

NO INTERVENTION

Social Initiation Motivation Intervention

EXPERIMENTAL
Behavioral: Social Initiation Motivation Intervention

Interventions

Social Initiation Motivation InterventionBEHAVIORAL

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
Social Initiation Motivation Intervention

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • diagnosed severe psychiatric or genetic disorder or medical problem;
  • severe disruptive behavior that would interfere with peer interactions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

  • 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.

    PMID: 33387236RESULT

Related Links

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Grace Gengoux, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

February 5, 2015

First Posted

February 10, 2015

Study Start

January 1, 2015

Primary Completion

July 19, 2017

Study Completion

November 5, 2020

Last Updated

January 8, 2021

Record last verified: 2021-01

Locations

US(1)