search
Back to results

Therapist and Parent Delivered Reciprocal Imitation Training for Young Children With Autism Spectrum Disorder (ParentRIT)

Primary Purpose

Autism Spectrum Disorder

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reciprocal Imitation Training (Therapist-Delivered)
Reciprocal Imitation Training (Therapist + Parent Delivered)
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

24 Months - 60 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Participants must not be the sibling of another study participant

Sites / Locations

  • The Ohio State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Therapist Delivered

Parent + Therapist Delivered

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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

Secondary Outcome Measures

Parenting Stress Index, 4th Edition
Motor Imitation Scales
Early Social Communication Scales
Proportion of time spent jointly engaged during Parent-Child Play Interaction
Proportion of time spent in joint engagement state (joint focus on same activity) during a 10-minute unstructured play interaction with parent

Full Information

First Posted
June 3, 2016
Last Updated
November 17, 2022
Sponsor
Ohio State University
search

1. Study Identification

Unique Protocol Identification Number
NCT03020927
Brief Title
Therapist and Parent Delivered Reciprocal Imitation Training for Young Children With Autism Spectrum Disorder
Acronym
ParentRIT
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Suspended
Why Stopped
Currently do not have resources/staff to enroll new participants.
Study Start Date
April 2016 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Therapist Delivered
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Parent + Therapist Delivered
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Reciprocal Imitation Training (Therapist-Delivered)
Other Intervention Name(s)
RIT
Intervention Description
Naturalistic Developmental Behavioral Intervention aimed at improving social imitation skills.
Intervention Type
Behavioral
Intervention Name(s)
Reciprocal Imitation Training (Therapist + Parent Delivered)
Other Intervention Name(s)
RIT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Unstructured Imitation Assessment (UIA)
Description
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).
Time Frame
Change from baseline to 10 weeks (immediately post-intervention)
Title
Percentage of parent acts imitated during Parent-Child Play Interaction
Description
Percentage of parent play acts and meaningful gestures imitated by the child during a 10-minute unstructured play interaction with parent
Time Frame
Change from baseline to 10 weeks (immediately post-intervention)
Secondary Outcome Measure Information:
Title
Parenting Stress Index, 4th Edition
Time Frame
Change from baseline to 10 weeks (immediately post-intervention)
Title
Motor Imitation Scales
Time Frame
10 weeks (immediately post-intervention), 3 months post-treatment, 6 months post-treatment
Title
Early Social Communication Scales
Time Frame
10 weeks (immediately post-intervention), 3 months post-treatment, 6 months post-treatment
Title
Proportion of time spent jointly engaged during Parent-Child Play Interaction
Description
Proportion of time spent in joint engagement state (joint focus on same activity) during a 10-minute unstructured play interaction with parent
Time Frame
Change from baseline to 10 weeks (immediately post-intervention)
Other Pre-specified Outcome Measures:
Title
Modified Behavior Intervention Rating Scale
Time Frame
10 weeks (immediately post-intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Participants must not be the sibling of another study participant
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Therapist and Parent Delivered Reciprocal Imitation Training for Young Children With Autism Spectrum Disorder

We'll reach out to this number within 24 hrs