CLINICAL TRIAL

Sensory Integration Therapy for Autistic Disorder

Recruiting · < 18 · All Sexes · Bronx, NY

This study is evaluating whether Sensory Integration Therapy may help improve symptoms of autism spectrum disorder.

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About the trial for Autistic Disorder

Eligible Conditions
Autism, Early Infantile · Autistic Disorder

Treatment Groups

This trial involves 2 different treatments. Sensory Integration Therapy 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Sensory Integration Therapy
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Applied Behavioral Analysis
BEHAVIORAL

Eligibility

This trial is for patients born any sex aged 18 and younger. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
) The person has a cognitive level that is 70 or above and is not able to communicate through words. show original
The person has difficulty understanding and responding to sensory information. show original
Guardians willing to attend 3 weekly sessions for the duration of the period and to refrain from initiation of any new behavioral, therapeutic or alternative treatments during the study period
The text is saying that the person has been diagnosed with ASD by a certified psychologist and that the diagnosis was based on the clinical impression, DSM-5 criteria, and cut off scores from the Autism Diagnostic Schedule -2 (ADOS) and the Autism Diagnostic Interview - Revised (ADI-R). show original
, children were enrolled at a mean age of 7.5 On average, the children enrolled were 7.5 years old when they were between 6.0 and 8.5 years old. show original
They have been stabilised on their dosage of medication and this will continue throughout the study. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Increase between week 0 and week 12 in functional adaptivity as assessed by AMPS, with follow up for stability of change at week 24
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Increase between week 0 and week 12 in functional adaptivity as assessed by AMPS, with follow up for stability of change at week 24.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Sensory Integration Therapy will improve 2 primary outcomes and 1 secondary outcome in patients with Autistic Disorder. Measurement will happen over the course of Reduction between week 0 and week 12 in repetitive behavior scale score as assessed by RBS-R, with follow up for stability of change at week 24.

Repetitive Behavior Scale-Revised (RBS-R)
REDUCTION BETWEEN WEEK 0 AND WEEK 12 IN REPETITIVE BEHAVIOR SCALE SCORE AS ASSESSED BY RBS-R, WITH FOLLOW UP FOR STABILITY OF CHANGE AT WEEK 24
The RRB is a 43-item parent rating scale that measures the presence and severity of 6 types of repetitive behaviors: rituals/sameness (12 items), self-injurious behavior (8 items), stereotypic behavior (9 items), compulsive behavior (6 items), and restricted interests (3 items). The RBS-R yields an overall Total Score and six Subscale Scores, and has demonstrated reliability, stability, and validity in large autism samples.
The Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT) Daily Living
INCREASE BETWEEN WEEK 0 AND WEEK 12 IN FUNCTIONAL ADAPTIVITY AS ASSESSED BY PEDI-CAT, WITH FOLLOW UP FOR STABILITY OF CHANGE AT WEEK 24
The PEDI-CAT provides a valid and reliable assessment of the child's ability to perform daily living skills. The psychometric properties including validity and reliability are well documented and the PEDI-CAT showed good discriminant validity between groups of children with and without disabilities in all domains. Score estimates were found to be stable over time with strong test-retest reliability
The Assessment of Motor and Process Skills (AMPS)
INCREASE BETWEEN WEEK 0 AND WEEK 12 IN FUNCTIONAL ADAPTIVITY AS ASSESSED BY AMPS, WITH FOLLOW UP FOR STABILITY OF CHANGE AT WEEK 24
An observation-based, standardized performance assessment of daily living skills . It has been standardized on more than 150,000 persons, ages 2-100 years of age, internationally and cross-culturally.

Who is running the study

Principal Investigator
S. M.
Prof. Sophie Molholm, Associate Professor
Albert Einstein College of Medicine

Patient Q & A Section

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

What causes autistic disorder?

There may be different aetiologies, and it is possible that some cases of autism are due to defects in the development of the brain during the embryonic stage.\n

Anonymous Patient Answer

Can autistic disorder be cured?

There is no evidence to suggest that there is a cure for autism. The only treatments which have been proven more effective in reducing symptoms of autism are early intervention, occupational therapy, and speech therapy. Evidence is limited and often conflicting. There are no medications whose effectiveness is wellestablished for autism.

Anonymous Patient Answer

What are common treatments for autistic disorder?

In contrast to autism, a significant number of subjects in this autism population have a history of ADHD, often being on stimulant medication, and a significantly higher percentage had comorbid oppositional defiant disorder when compared to age-mates without ADHD (p < 0.001). We found no indications of a higher rate of comorbid psychiatric conditions in the autism group. These studies indicate that the treatments for ADHD in autism are not necessarily the same as, or the same as those given to persons without ADHD.

Anonymous Patient Answer

What is autistic disorder?

About 4% of the autistic spectrum is of mild to moderate severity. Most autistic spectrum individuals meet the criteria for ADHD, which is an overlap syndrome. Autistic spectrum individuals, particularly Asperger syndrome and high functioning autism, may also meet the criteria for obsessive compulsive disorder and major depressive disorder. We therefore propose the term 'autistic spectrum overlap' (ASO) to cover what is currently termed 'Asperger syndrome' and 'autism.

Anonymous Patient Answer

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

Most recently, an estimated 1 out of every 100 children at some point in time may have the autism spectrum disorder. This makes autism spectrum disorder the most common life-threatening, disabling and costly condition seen in American children. The condition accounts for approximately $1 billion in direct and indirect medical costs per year.

Anonymous Patient Answer

What are the signs of autistic disorder?

The primary behavioral signs of autistic disorder are a lack of social skills or interest in other people and an lack of sensory skills such as joint sensations and body movements. There are also secondary signs that depend more directly on the type and severity of the primary signs. The type of symptoms a person exhibits is not always the same across all types of autism.

Anonymous Patient Answer

What is the average age someone gets autistic disorder?

If autism was considered a chronic condition with onset late in childhood or young adult years, approximately 38% of people with autism spectrum disorder would have had their onset in the third [or fourth] year of life. The [mean age of diagnosis of autism] is 7.5 years. If autism was assumed to be a chronic condition with a slowly deteriorating course, perhaps as a function of the degree of [autism expression] and age of onset, then the mean date of diagnosis would be much later, at 11 years of age. If onset of autism spectrum disorder does appear in the late teens to thirties, then the mean age of onset might be at the other end of the spectrum.

Anonymous Patient Answer

Who should consider clinical trials for autistic disorder?

For individuals with ASD, clinical trial participation is a significant consideration. Individuals who are interested in clinical trial participation can take a holistic approach to treatment by participating in a clinical trial with a therapist and by attending a special education education class. Although clinical trials may not be the first option, it is an option.

Anonymous Patient Answer

Have there been any new discoveries for treating autistic disorder?

No new discoveries for treating autism were reported. New research should explore the potential of novel treatments such as gene therapy, neuroprotective agents, and antioxidants.

Anonymous Patient Answer

Does autistic disorder run in families?

Considered in the context of previous studies, this study suggests that AD is not a monogenic disorder for which familial transmission is a prerequisite; however, it is possible that one or two alleles are associated with the clinical subtype AD1.

Anonymous Patient Answer

How serious can autistic disorder be?

Recent findings illustrates that ASD is more severe when compared to neurotypical individuals with more disability-inducing behavior, self-injury, and psychiatric symptoms. Therefore, autistic disorder cannot be characterized as a mild-moderate form of a disorder. ASD should ideally be regarded as a life-threatening disorder; thus, specific diagnostic criteria and guidelines to manage ASD for patients in a medical emergency setting are needed.

Anonymous Patient Answer

What is sensory integration therapy?

SI therapy can reduce avoidance of sensory input, improve sensory processing and decrease aversive/phobia-like, sensory sensations. It can help autistic patients overcome their sensory avoidance behaviors. SI therapy was useful in reducing phobias. In addition to sensory processing, SI therapy can improve communication and social interaction skills.

Anonymous Patient Answer
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