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Social Skills Intervention for Autism
N/A
Recruiting
Led By Aarti Nair, PhD
Research Sponsored by Loma Linda University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
SSD participants must meet criteria for schizophrenia, schizophreniform, schizoaffective disorder, or unspecified schizophrenia spectrum and other psychotic disorder
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between baseline and final visit at week 16
Awards & highlights
Study Summary
This trial is examining how a social skills intervention may improve social cognition in adolescents with autism spectrum disorder or schizophrenia spectrum disorder by looking at changes in their brain function.
Who is the study for?
This trial is for adolescents aged 12-18 with Autism Spectrum Disorder (ASD) or Schizophrenia Spectrum Disorder (SSD), who have verbal and full-scale IQs over 70. They should not have significant medical conditions that affect brain imaging, no psychiatric history if they're typically developing controls, and must be able to safely undergo MRI scans.Check my eligibility
What is being tested?
The study tests the PEERS social skills intervention's effect on brain function in teens with ASD or SSD. It involves pre- and post-treatment MRI scans to observe neural changes after a 16-week program designed to enhance friendship quality and social skills.See study design
What are the potential side effects?
Since this trial focuses on behavioral intervention rather than medication, traditional side effects are not expected. However, participants may experience discomfort or anxiety during MRI scanning procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a type of schizophrenia or related disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change between baseline and final visit at week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between baseline and final visit at week 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The Awareness of Social Inference Test (TASIT)
The Social Attribution Task - Multiple Choice (SAT-MC, SAT-MC-II)
The computerized Penn Emotion Identification Task (PennCNB)
Secondary outcome measures
Functional MRI
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Patient armExperimental Treatment1 Intervention
Both ASD and SSD participants will undergo cognitive assessments and MRI imaging pre- and post- the 16-week PEERS social skills intervention.
Group II: Control armActive Control1 Intervention
Typically developing control participants will undergo cognitive assessments and MRI imaging 16 weeks apart with no intervention in between.
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Who is running the clinical trial?
Loma Linda UniversityLead Sponsor
306 Previous Clinical Trials
260,898 Total Patients Enrolled
5 Trials studying Autism Spectrum Disorder
252 Patients Enrolled for Autism Spectrum Disorder
Aarti Nair, PhDPrincipal InvestigatorLoma Linda University
1 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
100 Patients Enrolled for Autism Spectrum Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am an adolescent with ASD or SSD enrolled in the PEERS program.I am between 12 and 18 years old, and my condition is more common in males.I am a young person with psychosis receiving care at BMC.I have been diagnosed with a type of schizophrenia or related disorder.I don't have conditions like epilepsy that would affect brain scans.
Research Study Groups:
This trial has the following groups:- Group 1: Control arm
- Group 2: Patient arm
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 specific requirements for people who want to join this clinical trial?
"To be eligible for this research, participants must have a diagnosis of social communication and fall in the age range of 12 to 18. A total of 90 patients will be enrolled in the study."
Answered by AI
If an otherwise healthy person aged 49 or younger expresses interest in this research, would they be able to participate?
"This research is looking for participants who have not yet reached adulthood, specifically those between 12 and 18 years old."
Answered by AI
Are investigators still looking for volunteers for this clinical trial?
"Yes, this trial is still looking for participants and the most recent update on their status was on March 24th, 2022. The original posting date for the clinical trial was February 1st, 2022."
Answered by AI
What is the maximum number of individuals who can enroll in this clinical research?
"That is correct, the trial is still looking for participants. According to information on clinicaltrials.gov, the posting went up on February 1st of this year and was last updated March 24th. They are seeking a total of 90 individuals from a single location."
Answered by AI
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