Autism Spectrum Disorder Clinical Trial
— ParentRITNCT 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 |
Verified date | November 2022 |
Source | Ohio State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | The Ohio State University | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Ohio State University |
United States,
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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