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Behavioral Intervention
Telehealth Parent Training for PRT for Autism
N/A
Recruiting
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants will include children ages 2:0 to 5:11 years
Be younger than 18 years old
Must not have
Child participating in >15 hours per week of 1:1 ABA treatment at home
Unstable medical condition such as severe seizures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12
Awards & highlights
Summary
This trial will examine if training parents in Pivotal Response Treatment (PRT) for autism via secure video conferencing is effective, if parents can learn to deliver PRT in the home setting, and if their children will show greater improvement in functional communication skills.
Who is the study for?
This trial is for children aged 2 to 5 with Autism Spectrum Disorder (ASD) and significant language delays. They must have been diagnosed or suspected of ASD, speak English as a primary language, and have stable treatments with no major changes expected during the study. Children who receive extensive ABA therapy, live close to Stanford University, or have severe behavioral issues are not eligible.Check my eligibility
What is being tested?
The trial tests if parents can learn Pivotal Response Treatment (PRT) through video calls to help their kids improve communication skills. It compares kids getting PRT via telehealth against those on a waitlist. The study involves weekly sessions over three months and measures how well parents apply PRT and any progress in the child's verbal abilities.See study design
What are the potential side effects?
Since this intervention involves educational training without medical procedures or drugs, there aren't typical side effects like you'd see with medication. However, participating families may experience increased stress due to time commitment or frustration if improvements are not immediately observed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is between 2 and 5 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My child is getting more than 15 hours a week of one-on-one ABA therapy at home.
Select...
I do not have severe seizures or other unstable medical conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Parent Fidelity of PRT Implementation from Baseline to Week 12
Secondary outcome measures
Change in Child Frequency of Functional Utterances from Baseline to Week 12
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PRT TelehealthExperimental Treatment1 Intervention
Participating parents will receive 12 weekly 60-minute parent training sessions via secure videoconference to learn Pivotal Response Treatment
Group II: WaitlistActive Control1 Intervention
Participants will continue stable community-based treatments
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pivotal Response Treatment
2016
N/A
~100
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,411 Previous Clinical Trials
17,462,899 Total Patients Enrolled
34 Trials studying Autism Spectrum Disorder
4,087 Patients Enrolled for Autism Spectrum Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with ASD or suspected to have it, confirmed by ADI-R.My child's first language is not English.You or a family member have a serious mental illness or an unstable medical condition.You have already tried a treatment that is considered to be effective for your condition.I am an English-speaking parent who can participate in all study procedures.I've been on a stable treatment plan for over 2 weeks with limited speech therapy.My child is getting more than 15 hours a week of one-on-one ABA therapy at home.I can speak clearly enough to be understood in a video.You have severe behavioral problems, such as hurting yourself or others, that could be dangerous during the study.I do not have severe seizures or other unstable medical conditions.My child is between 2 and 5 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Waitlist
- Group 2: PRT Telehealth
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.
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