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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pretest (immediately prior to) and posttest (immediately following) the 8-week active social intervention phase for children in both conditions, and three months later (follow-up) for those randomized to the social intervention.
Awards & highlights
Study Summary
This trial is testing the feasibility and initial efficacy of an after-school social intervention delivered by paraprofessionals in school settings for children with high-functioning autism spectrum disorder.
Who is the study for?
This trial is for higher-functioning children with autism spectrum disorder (hfASD) who have no intellectual disability. They must have a prior clinical diagnosis of ASD, confirmed by specific assessments and an IQ score over 70. Children with evidence of psychosis are not eligible.Check my eligibility
What is being tested?
The study tests an after-school social intervention delivered by paraprofessionals to improve social skills in children with hfASD. It involves group sessions and games four days a week for eight weeks, comparing the effects against a waitlist control group.See study design
What are the potential side effects?
Since this is a non-medical intervention focusing on social skills development, traditional side effects associated with medications are not expected. However, individual experiences may vary based on personal comfort and adaptability to the program.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pretest (immediately prior to) and posttest (immediately following) the 8-week active social intervention phase for children in both conditions, and three months later (follow-up) for those randomized to the social intervention.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pretest (immediately prior to) and posttest (immediately following) the 8-week active social intervention phase for children in both conditions, and three months later (follow-up) for those randomized to the social intervention.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Social Knowledge Assessment (SKA)
Secondary outcome measures
Adapted Skillstreaming Checklist (ASC)
Social Competence Observation Scale (SCOS)
Social Responsiveness Scale, 2nd Edition, School Age Form (SRS-2)
Other outcome measures
Attendance Rate
Attrition Rate
Child Satisfaction Survey
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Social interventionExperimental Treatment1 Intervention
The social intervention consists of four 90-minute sessions per week delivered over eight weeks by paraprofessional staff to children with hfASD as part of their existing after-school program.
Group II: No-treatment controlActive Control1 Intervention
Children in the no-treatment control condition will receive no after-school social programming during the active social intervention study phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Social intervention
2015
N/A
~210
Find a Location
Who is running the clinical trial?
Canisius CollegeLead Sponsor
1 Previous Clinical Trials
103 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Autism Spectrum Disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Social intervention
- Group 2: No-treatment control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies for participants in this study?
"Based on the information published online, this clinical trial is not currently recruiting. It was posted initially in October 2022 and last edited at the start of September that same year. Although no more patients are required for this particular study, there are 190 other trials looking for volunteers as we speak."
Answered by AI
Is the age range for this trial inclusive of individuals over 45 years old?
"This medical experiment is accepting participants aged between 7 and 12 years old."
Answered by AI
For whom is this research initiative suitable?
"This trial seeks 48 individuals with a prior diagnosis of autistic disorder between the age range of 7 to 12. To qualify, patients must meet these prerequisites: An Autism Diagnostic Interview-Revised confirmed ASD diagnosis, and an intelligence quotient score above 70 on the Wechsler Abbreviated Scale of Intelligence-2nd Edition."
Answered by AI
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