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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT03020927
Other study ID # 2015B0475
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date December 2023

Study information

Verified date November 2022
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Suspended
Enrollment 30
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 24 Months to 60 Months
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Reciprocal Imitation Training (Therapist-Delivered)
Naturalistic Developmental Behavioral Intervention aimed at improving social imitation skills.
Reciprocal Imitation Training (Therapist + Parent 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.

Locations

Country Name City State
United States The Ohio State University Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Modified Behavior Intervention Rating Scale 10 weeks (immediately post-intervention)
Primary 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)
Primary 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 Parenting Stress Index, 4th Edition Change from baseline to 10 weeks (immediately post-intervention)
Secondary Motor Imitation Scales 10 weeks (immediately post-intervention), 3 months post-treatment, 6 months post-treatment
Secondary Early Social Communication Scales 10 weeks (immediately post-intervention), 3 months post-treatment, 6 months post-treatment
Secondary 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 Change from baseline to 10 weeks (immediately post-intervention)
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