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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
No Placebo-Only Group

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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~child's 6,9,12,15,18 and 24 months of age
This trial's timeline: 3 weeks for screening, Varies for treatment, and child's 6,9,12,15,18 and 24 months of age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mullen Early Learning Scales (MSEL)
Secondary study objectives
LENA
Parent-Child Interaction (PCX)
Resting electroencephalogram test (EEG)
Other study objectives
Autism Diagnostic Observation Schedule-2 (ADOS-2)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~80

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,562 Previous Clinical Trials
10,262,221 Total Patients Enrolled
University of Massachusetts, WorcesterOTHER
362 Previous Clinical Trials
992,910 Total Patients Enrolled

Media Library

COACH Clinical Trial Eligibility Overview. Trial Name: NCT05853861 — N/A
Monitoring Research Study Groups: MONITOR, COACH
Monitoring Clinical Trial 2023: COACH Highlights & Side Effects. Trial Name: NCT05853861 — N/A
COACH 2023 Treatment Timeline for Medical Study. Trial Name: NCT05853861 — N/A
~93 spots leftby Dec 2027
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