Reciprocal Imitation Training (Therapist + Parent Delivered) for Autism Spectrum Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Ohio State University, Columbus, OH
Autism Spectrum Disorder
Reciprocal Imitation Training (Therapist + Parent Delivered) - Behavioral
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a parent education component to an existing intervention may improve outcomes for children with autism spectrum disorder.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether Reciprocal Imitation Training (Therapist + Parent Delivered) will improve 2 primary outcomes, 4 secondary outcomes, and 1 other outcome in patients with Autism Spectrum Disorder. Measurement will happen over the course of Change from baseline to 10 weeks (immediately post-intervention).

10 weeks (immediately post-intervention)
Modified Behavior Intervention Rating Scale
Month 6
Early Social Communication Scales
Motor Imitation Scales
Week 10
Parenting Stress Index, 4th Edition
Percentage of parent acts imitated during Parent-Child Play Interaction
Proportion of time spent jointly engaged during Parent-Child Play Interaction
Unstructured Imitation Assessment (UIA)

Trial Safety

Trial Design

2 Treatment Groups

Therapist Delivered
1 of 2
Parent + Therapist Delivered
1 of 2
Active Control
Experimental Treatment

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Reciprocal Imitation Training (Therapist + Parent Delivered) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Parent + Therapist Delivered
Behavioral
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.
Therapist Delivered
Behavioral
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 10 weeks (immediately post-intervention), 3 months post-treatment, 6 months post-treatment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 10 weeks (immediately post-intervention), 3 months post-treatment, 6 months post-treatment for reporting.

Who is running the study

Principal Investigator
K. W.
Prof. Katherine Walton, Assistant Professor of Psychology and Psychiatry
Ohio State University

Closest Location

The Ohio State University - Columbus, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

What are common treatments for autism spectrum disorder?

"Attention-deficit hyperactivity disorder (ADHD) is a common comorbidity in ASD. In severe cases, behavioral interventions may lead to significant improvement in ASD, although ASD can be managed with medication alone and/or behavior therapy. At least one antipsychotic agent has been useful in treating ASD with varying degrees of success: aripiprazole and olanzapine. Despite the availability of treatment for ADHD, no convincing evidence supports the use of stimulants." - Anonymous Online Contributor

Unverified Answer

Can autism spectrum disorder be cured?

"We are now confident that ASD cannot be cured. However, our results from animal models point to the potential for early intervention to decrease the degree of pathology, and potentially the degree of symptoms, which will, at the least, give hope to a minority of patients that a cure has never been proven." - Anonymous Online Contributor

Unverified Answer

What causes autism spectrum disorder?

"The cause of ASD is still unknown. However, recent insights that suggest ASD is linked to genetics, and ASD is linked to a specific kind of mutation in a single gene, supports the plausibility of the genetic basis of ASD." - Anonymous Online Contributor

Unverified Answer

How many people get autism spectrum disorder a year in the United States?

"Inclusion of 1 million people with autism spectrum disorder in a sample of 5 million people with autism will generate a large enough sample to generate useful estimates of the prevalence of autism spectrum disorder in the United States. Recent findings suggests that more than 1 year of surveillance may be required before definitive estimates of prevalence can be obtained." - Anonymous Online Contributor

Unverified Answer

What is autism spectrum disorder?

"Autistic children and adults are typically highly intelligent, have low thresholds for inappropriate behaviors and show atypical sensory or motor functioning. Most individuals with ASD display clinically significant delays in gross intellectual development (mean >2 standard deviations below the mean) at some age and/or meet one or more diagnostic criteria for ASD. While not a symptom of ASD itself, difficulties in accurately perceiving visual and auditory stimuli due to abnormal sensory processing are commonly observed in children and adults with ASD. Given this pervasive sensory dysfunction, future studies should investigate the relationship between sensory processing profiles and symptom expression in ASDs (ASD diagnosis-associated traits of stereotypy, sensory hypersensitivity/hypo-responsivity and social impairment)." - Anonymous Online Contributor

Unverified Answer

What are the signs of autism spectrum disorder?

"Autism is a clinical diagnosis. It should be noted that there is considerable variation in the presentation of autism and autism spectrum disorders across and among individuals in the same family. Individuals in the same family may present in different ways. Specific signs of autism spectrum disorder may include the following.\n1. Specific language impairment\n2. Social impairment\n3. Nonverbal communication difficulties\n4. Sensory processing difficulties\n5. Motor communication delays\n6. Attention and school problems\n7. Sensory overload\n8. Severe learning disabilities\none. The DSM-5 criteria also support the inclusion of the following symptoms if they are not better explained by another condition or disorder.\n1." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for autism spectrum disorder?

"While there are few large multicenter clinical trials designed specifically for children with ASD, there are numerous clinical trials and a large body of clinical evidence supporting the usefulness of intervention. These indications, in addition to the theoretical rationale for the efficacy of intervention, could serve as criteria for defining a clinical trial population." - Anonymous Online Contributor

Unverified Answer

Is reciprocal imitation training (therapist + parent delivered) safe for people?

"Results from a recent clinical trial suggest that it is potentially safe to deliver the parent-guided MI training in both a therapist and parent-led context. It is also suggested that reciprocal imitation training may be an adjunct to the behavioural approach." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving reciprocal imitation training (therapist + parent delivered)?

"No studies have been published that are focused on this practice. However, it does meet at least one of the primary criteria for a clinical trial because it is based on sound scientific rationale. Additional research is needed to ensure that reciprocal imitation training is a valid, practical, and effective intervention to reduce autism symptoms (or that it does) in the context of a clinical trial." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of reciprocal imitation training (therapist + parent delivered)?

"Findings from a recent study highlight the common adverse effects of reciprocal imitation training and provide useful, practical methods to monitor and optimize treatment. The current results contribute to our understanding of the nature and scope of the common adverse effects." - Anonymous Online Contributor

Unverified Answer

What is reciprocal imitation training (therapist + parent delivered)?

"[Specifically looking at the development of reciprocal imitation training for autistic toddlers and their parents, this study shows that the quality and the quantity of the intervention (therapist + parent delivered) are associated with a significant improvement in autism symptomatology for toddlers with severe autism] (http://wwwnccp.falklandinstitute.org/publications/Reciprocal_Imitation_Training_for_Autistic_Toddlers_and_Their_Parents_at_Falkland_Institute_University_of_America_at_Barry_E_Schott_Institute_for_Ageri-Research_and_Health_Stud.)." - Anonymous Online Contributor

Unverified Answer

How does reciprocal imitation training (therapist + parent delivered) work?

"Compared with control groups, children of the therapist + parent-delivered condition showed larger improvement in both performance measures and parent ratings of motivation. This may represent a unique phenomenon that is mediated by increased parent engagement." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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