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Behavioral Intervention

Telehealth Intervention for Disruptive Behavior in Autism (THRIVE-ASD Trial)

N/A
Waitlist Available
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 2:0 - 6:11 years old
Have a diagnosis of ASD based on a positive Autism Diagnostic Observation Schedule (ADOS-2), a semi-structured parent interview, record review, and an ASD DSM-5 criteria checklist
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-treatment to follow-up (~24 weeks)
Awards & highlights

THRIVE-ASD Trial Summary

This trial is testing a shorter, telehealth version of Parent Child Interaction Therapy for young children with ASD and disruptive behavior problems. Families will be randomly assigned to receive 10 sessions of Tele-PCIT or Treatment as Usual, and will be assessed at baseline, post-treatment, and 3 months after.

Who is the study for?
This trial is for young children aged 2 to almost 7 with Autism Spectrum Disorder (ASD) who show disruptive behaviors. They must have a confirmed ASD diagnosis, understand language at a two-year-old level, come from low-income families on Medicaid, and not be on unstable psychotropic medications or exhibit severe self-injury.Check my eligibility
What is being tested?
The study tests a short version of Parent Child Interaction Therapy (PCIT) done through telehealth against the usual treatment methods for managing disruptive behaviors in kids with ASD. Participants will be randomly placed into one of these two groups and assessed before, after treatment, and three months later.See study design
What are the potential side effects?
Since this trial involves behavioral therapy delivered via telehealth rather than medication, there are no direct medical side effects. However, participants may experience stress or frustration associated with new therapy routines.

THRIVE-ASD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child is between 2 and 6 years old.
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I have been diagnosed with ASD through various assessments including ADOS-2.
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My understanding of language is at least as good as a typical 2-year-old's.

THRIVE-ASD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-treatment to follow-up (~24 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-treatment to follow-up (~24 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Child Behavior Problems as assessed by Behavior Assessment System for Children-3rd Edition (BASC-3)
Change in Child Behavior Problems as assessed by Disruptive Behavior Disorders Rating Scale (DBD)
Change in Child Behavior Problems as assessed by Eyberg Child Behavior Inventory (ECBI)
+4 more
Secondary outcome measures
Impact of Barriers on Treatment Engagement as assessed by Barriers to Treatment Participation Scale (BTPS)
Parent Satisfaction with Tele-PCIT as assessed by Therapy Attitude Inventory (TAI)

THRIVE-ASD Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tele-PCIT (Parent-Child Interaction Therapy)Experimental Treatment1 Intervention
Group II: Treatment as UsualActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,180 Total Patients Enrolled
4 Trials studying Autism Spectrum Disorder
52 Patients Enrolled for Autism Spectrum Disorder
Health Resources and Services Administration (HRSA)FED
84 Previous Clinical Trials
151,407 Total Patients Enrolled
11 Trials studying Autism Spectrum Disorder
2,168 Patients Enrolled for Autism Spectrum Disorder

Media Library

Tele-PCIT (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05056922 — N/A
Autism Spectrum Disorder Research Study Groups: Tele-PCIT (Parent-Child Interaction Therapy), Treatment as Usual
Autism Spectrum Disorder Clinical Trial 2023: Tele-PCIT Highlights & Side Effects. Trial Name: NCT05056922 — N/A
Tele-PCIT (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05056922 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently openings for participants in this research study?

"According to the data housed on clinicaltrials.gov, this trial is not taking new patients as recruitment concluded after its initial posting on February 11th 2022 and no subsequent updates were made thereafter. However, there are currently 361 other trials that could be of interest for potential participants."

Answered by AI

How can I register to participate in this research project?

"This clinical trial is seeking 80 participants with autism spectrum disorder that are between two and 83 months old."

Answered by AI

Does the study welcome individuals aged fifty and above as participants?

"According to the requirements outlined in this medical study, participants must range between 2 and 83 months old."

Answered by AI
~11 spots leftby Aug 2024