Your session is about to expire
← Back to Search
Behavioral Intervention
Peer Interventions for Autism (PIPA Trial)
N/A
Recruiting
Research Sponsored by University of Kansas
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 secondary at baseline, 5 weeks, 12 weeks, and 16 weeks
Awards & highlights
PIPA Trial Summary
This trial will evaluate interventions to improve communication in preschoolers with ASD who have limited or no spoken language. Kids with ASD can benefit from peer-mediated interventions, but 30% remain minimally-verbal. This study will test different approaches to help improve communication.
Who is the study for?
This trial is for preschoolers aged 3 to 6 with Autism Spectrum Disorder who have limited or no spoken language. They should be using or ready to use a speech-generating device and primarily speak English at home. Children must not have major medical conditions besides ASD, lack symbol discrimination skills, or have impairments that prevent play with peers.Check my eligibility
What is being tested?
The study tests peer-mediated interventions (PMIs) like Stay-Play-Talk in various forms to improve social communication in children with autism. It uses a SMART design where kids start with basic PMI and may advance based on their response, potentially adding devices for communication or more direct teaching strategies.See study design
What are the potential side effects?
Since the interventions are behavioral treatments involving peer interaction and communication devices rather than medications, traditional side effects are not expected. However, there might be variations in individual responses to the intervention's social and communicative demands.
PIPA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ secondary at baseline, 5 weeks, 12 weeks, and 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~secondary at baseline, 5 weeks, 12 weeks, and 16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in rate of peer-directed communication acts
Secondary outcome measures
Aberrant Behavior Checklist
Change in expressive language
Change in expressive language multi-words
+4 morePIPA Trial Design
6Treatment groups
Experimental Treatment
Active Control
Group I: Stay_Play_Talk Plus Followed by Stay_Play_Talk Plus (SPT Plus Responders)Experimental Treatment1 Intervention
After being randomly assigned to the SPT Plus condition, these participants responded and therefore remained in this condition
Group II: Stay_Play_Talk Plus Followed by Randomization to Stay_Play_Talk Plus (SPT Plus - SPT Plus)Experimental Treatment1 Intervention
After being randomly assigned to the SPT Plus condition, these participants did not respond and were randomized to Stay_Play_Talk Plus in the second stage.
Group III: Stay_Play_Talk Plus Followed by Randomization to Stay_Play_Talk Advanced (SPT Plus - SPT Advanced)Experimental Treatment2 Interventions
After being randomly assigned to the SPT Plus condition, these participants did not respond and were randomized to Stay_Play_Talk Advanced condition in the second stage which incorporates direct instruction.
Group IV: Stay_Play_Talk Basic Followed by Randomization to Stay_Play_Talk Plus (SPT Basic - SPT Plus)Experimental Treatment2 Interventions
After being randomly assigned to the SPT Basic condition, these participants did not respond and were randomized to Stay_Play_Talk Plus in the second stage.
Group V: Stay-Play_Talk Basic Followed by Stay_Play_Talk Basic - (SPT Basic Responders)Active Control1 Intervention
After being randomly assigned to the SPT Basic condition, these participants responded and therefore remained in this condition
Group VI: Stay_Play_Talk Basic Followed by Randomization to Stay_Play_Talk Basic (SPT Basic - SPT BASIC)Active Control1 Intervention
After being randomly assigned to the SPT Basic condition, these participants did not respond but were randomized to stay in this condition to examine longer duration in this treatment.
Find a Location
Who is running the clinical trial?
Emory UniversityOTHER
1,640 Previous Clinical Trials
2,560,525 Total Patients Enrolled
23 Trials studying Autism Spectrum Disorder
21,455 Patients Enrolled for Autism Spectrum Disorder
University of KansasLead Sponsor
147 Previous Clinical Trials
325,729 Total Patients Enrolled
6 Trials studying Autism Spectrum Disorder
1,140 Patients Enrolled for Autism Spectrum Disorder
University of North CarolinaOTHER
167 Previous Clinical Trials
1,449,495 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I primarily speak English at home.I have physical or sensory issues that stop me from playing with others.I have no visual or hearing problems affecting my ability to follow instructions.
Research Study Groups:
This trial has the following groups:- Group 1: Stay-Play_Talk Basic Followed by Stay_Play_Talk Basic - (SPT Basic Responders)
- Group 2: Stay_Play_Talk Basic Followed by Randomization to Stay_Play_Talk Plus (SPT Basic - SPT Plus)
- Group 3: Stay_Play_Talk Basic Followed by Randomization to Stay_Play_Talk Basic (SPT Basic - SPT BASIC)
- Group 4: Stay_Play_Talk Plus Followed by Randomization to Stay_Play_Talk Advanced (SPT Plus - SPT Advanced)
- Group 5: Stay_Play_Talk Plus Followed by Stay_Play_Talk Plus (SPT Plus Responders)
- Group 6: Stay_Play_Talk Plus Followed by Randomization to Stay_Play_Talk Plus (SPT Plus - SPT Plus)
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.
Is this experiment open to individuals of advanced age?
"This research study is searching for participants aged 3 to 6 years old."
Answered by AI
What is the current enrollment limit of participants in this medical study?
"Affirmative. Clinicaltrials.gov data implies that this investigation, which first appeared on February 13th 2023, is still recruiting participants. Potential volunteers must come from a single location and number 132 in total."
Answered by AI
Are there any currently available slots for participation in this experiment?
"Affirmative. According to records hosted on clinicaltrials.gov, this experiment is actively recruiting test subjects and has been since February 13th 2023. The most recent update was made March 22nd 2023 and 132 individuals across 1 site are needed for the trial."
Answered by AI
Who can participate in this trial?
"This trial seeks 132 autistic individuals aged between 3 and 6 years old, who fulfil the following criteria: a diagnosis of Autism Spectrum Disorder (ASD), limited or no speech capability defined by fewer than 20 functional words spontaneously used, likely to use or already using an augmentative communication device, access to peers without disabilities, and English as the primary language spoken at home."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger