NCT03020927

Brief Summary

The purpose of this study is to examine whether adding a parent education component to an existing intervention (Reciprocal Imitation Training) results in improved outcomes for children with Autism Spectrum Disorder. Reciprocal Imitation Training (RIT) is a behavioral intervention designed to improve spontaneous imitation skills in young children with Autism Spectrum Disorder (ASD). Previous research suggests that it can be effective when used by trained therapists, teachers, siblings, and parents of children with ASD. However, it is unclear to what extent training parents to use RIT strategies in the home environment may enhance outcomes, compared to having therapists implement RIT individually with the child. The study will compare two different versions of RIT for young children with ASD: (1) two 60-minute weekly sessions of therapist-implemented RIT and (2) one weekly 60-minute session of therapist-implemented RIT and one weekly 60-minute session of parent education about using RIT in the home environment. The investigators will examine child and family outcomes between these two intervention types. Outcomes examined will include: (1) spontaneous and prompted imitation skills in the child with ASD, (2) social communication skills in the child with ASD, (3) parent stress, and (4) parent and child behaviors during parent-child play interactions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

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

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

6.3 years

First QC Date

June 3, 2016

Last Update Submit

April 21, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Unstructured Imitation Assessment (UIA)

    The Unstructured Imitation Assessment (UIA) is a semi-structured, standardized test of imitation skills containing 10 object imitation and 10 gesture imitation tasks (Ingersoll \& Meyer, 2011).

    Change from baseline to 10 weeks (immediately post-intervention)

  • Percentage of parent acts imitated during Parent-Child Play Interaction

    Percentage of parent play acts and meaningful gestures imitated by the child during a 10-minute unstructured play interaction with parent

    Change from baseline to 10 weeks (immediately post-intervention)

Secondary Outcomes (4)

  • Parenting Stress Index, 4th Edition

    Change from baseline to 10 weeks (immediately post-intervention)

  • Motor Imitation Scales

    10 weeks (immediately post-intervention), 3 months post-treatment, 6 months post-treatment

  • Early Social Communication Scales

    10 weeks (immediately post-intervention), 3 months post-treatment, 6 months post-treatment

  • Proportion of time spent jointly engaged during Parent-Child Play Interaction

    Change from baseline to 10 weeks (immediately post-intervention)

Other Outcomes (1)

  • Modified Behavior Intervention Rating Scale

    10 weeks (immediately post-intervention)

Study Arms (2)

Therapist Delivered

ACTIVE COMPARATOR

Children in the therapist-delivered condition will receive two, 60-minute long sessions of Reciprocal Imitation Training each week for ten consecutive weeks. These sessions will be delivered by trained graduate, undergraduate, and post-graduate research staff. Parents will be permitted to observe sessions via live video, but will not be directly involved in intervention.

Behavioral: Reciprocal Imitation Training (Therapist-Delivered)

Parent + Therapist Delivered

EXPERIMENTAL

Children in the parent + therapist-delivered condition will receive one, 60-minute long session of Reciprocal Imitation Training each week for ten consecutive weeks. These sessions will be delivered by trained graduate, undergraduate, and post-graduate research staff. During the same period of time, parents/guardians of children will receive one, 60-minute long parent education session per week with graduate and post-graduate research staff, aimed at teaching parents to implement Reciprocal Imitation Training at home with the child.

Behavioral: Reciprocal Imitation Training (Therapist + Parent Delivered)

Interventions

Naturalistic Developmental Behavioral Intervention aimed at improving social imitation skills.

Also known as: RIT
Therapist Delivered

Naturalistic Developmental Behavioral Intervention aimed at improving social imitation skills, using a combination of therapist-delivered intervention and parent training to deliver intervention in the home setting.

Also known as: RIT
Parent + Therapist Delivered

Eligibility Criteria

Age24 Months - 60 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • have a community diagnosis of Autism Spectrum Disorder (as reported by parent)
  • meet cutoff for "Autism" or "Autism Spectrum" on the Autism Diagnostic Observation Schedule, 2nd Edition
  • be between 24 and 60 months of age at the time of study enrollment
  • demonstrate difficulties with imitation skills on the Motor Imitation Scales and/or the Unstructured Imitation Assessment during pre-treatment assessments

You may not qualify if:

  • Participants must not be the sibling of another study participant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychology and Psychiatry

Study Record Dates

First Submitted

June 3, 2016

First Posted

January 13, 2017

Study Start

April 1, 2016

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations