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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
Must not have
Presence of severe self-injurious behavior
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-treatment to follow-up (~24 weeks)
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I engage in severe self-harm.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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)

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: 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
968 Previous Clinical Trials
7,399,178 Total Patients Enrolled
4 Trials studying Autism Spectrum Disorder
52 Patients Enrolled for Autism Spectrum Disorder
Health Resources and Services Administration (HRSA)FED
85 Previous Clinical Trials
151,587 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
~9 spots leftby Apr 2025
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