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Early Intervention Coaching for Infants at Risk of Autism (PETAL Trial)
N/A
Recruiting
Research Sponsored by University of California, Los Angeles
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 child's 6,9,12,15,18 and 24 months of age
Awards & highlights
PETAL Trial Summary
This trial will study when to intervene with special coaching for infants at risk for autism for best communication & language outcomes.
Who is the study for?
This trial is for infants aged 6-8 months who are at risk for autism because they have an older sibling with the condition. They must come from very low-income families in Los Angeles and not have seizures, physical disorders, other syndromes or diseases, sensory or motor impairments, genetic syndromes like Down Syndrome, or be born before 34 weeks of gestation.Check my eligibility
What is being tested?
The PETAL study tests when to start a parent-mediated coaching intervention (at 9, 12, or 15 months) to improve communication and language by age two in infants at risk for autism. It compares ongoing monitoring with adding interventions like JASPER and Babble Bootcamp based on assessments.See study design
What are the potential side effects?
Since this trial involves educational and developmental interventions rather than medical treatments, traditional side effects associated with medications are not expected.
PETAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ child's 6,9,12,15,18 and 24 months of age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~child's 6,9,12,15,18 and 24 months of age
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mullen Early Learning Scales (MSEL)
Secondary outcome measures
LENA
Parent-Child Interaction (PCX)
Resting electroencephalogram test (EEG)
Other outcome measures
Autism Diagnostic Observation Schedule-2 (ADOS-2)
PETAL Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: COACHExperimental Treatment2 Interventions
Participants will be provided with a blended intervention of two evidence tested intervention, JASPER and Babble Bootcamp along with continued monitoring.
Group II: MONITORActive Control1 Intervention
Participants in this arm will be provided with information to track the early development of their infants, along with specific developmentally targeted activities.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JASPER
2018
N/A
~20
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,532 Previous Clinical Trials
10,265,128 Total Patients Enrolled
University of Massachusetts, WorcesterOTHER
343 Previous Clinical Trials
986,470 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child does not have any sensory, motor impairments, or genetic syndromes.I am eligible for the study regardless of my gender.My infant is scheduled for surgery within the next year.My baby was born before 34 weeks of pregnancy.My infant has other health conditions or syndromes besides the main illness.My infant, aged 6-8 months, has an older sibling with ASD.My infant has seizures and isn't stable on medication.
Research Study Groups:
This trial has the following groups:- Group 1: MONITOR
- Group 2: COACH
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.
Does this investigation accept participants of forty or fewer years in age?
"According to the criteria for this medical experiment, infants between 6 and 8 Months old are eligible."
Answered by AI
Who has the opportunity to participate in this research endeavor?
"To be considered, potential participants must have consistent monitoring and be between 6-8 months old. This clinical trial is looking to enrol a total of 140 individuals."
Answered by AI
Are there any open slots available for participants to join this trial?
"As indicated by the clinicaltrials.gov portal, this research project is not currently recruiting participants. It was first published on July 1st 2023 and last amended on May 8th 2023. Although no longer seeking volunteers, there are alternative medical studies actively enrolling patients at present."
Answered by AI
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