Clinical Trials Directory

Trials / Completed

CompletedNCT05056922

Telehealth Rapid Intervention for Externalizing Behaviors in ASD

THRIVE-ASD: Telehealth Rapid Intervention for Externalizing Behaviors in ASD

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
80 (actual)
Sponsor
Medical University of South Carolina · Academic / Other
Sex
All
Age
2 Years – 83 Months
Healthy volunteers
Accepted

Summary

The purpose of this research study is to evaluate a time-limited version of Parent Child Interaction Therapy (PCIT) delivered via telehealth for young children with autism spectrum disorder (ASD) and disruptive behavior problems. Families will be randomly assigned to receive 10 sessions of Tele-PCIT or Treatment as Usual. Families will complete a baseline assessment, a post-treatment assessment, and a 3-month follow-up.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTele-PCITFamilies randomized to Tele-PCIT will receive a time-limited version of PCIT via telehealth. The first 5 sessions focus on the child directed interaction (CDI) phase. The first session includes a teaching session where the parent will learn PRIDE/"Do" skills and "Don't" skills. The next 4 CDI sessions include coaching where the therapist coaches the parent on the these skills within the context of play. The first PDI session includes a teaching session where parents will be given instructions for providing commands and timeout procedures. During the 4 PDI coaching sessions, the therapist coaches the parent through timeout procedures. Handouts are emailed to families throughout therapy. The treatment period is 12 weeks to complete the 10 sessions to account for scheduling challenges. Families will be provided a Bluetooth headset for sessions. Families who do not have access to a computer, tablet, or smartphone with internet access will be provided with a tablet for therapy use.
BEHAVIORALTreatment as UsualFamilies randomized to Treatment-as-Usual (TAU) will receive brief feedback and psychoeducation during the baseline visit and will be provided with community resources and referrals as needed. The TAU procedures will reflect the level of care families receive after an ASD assessment or professional consultation in our own clinic. For addressing behavioral concerns specifically, families will be provided handouts on behavior management tips, given access to a webinar workshop reviewing basic behavioral parenting principles, and instructed to engage with available services. The Vanderbilt Treatment \& Research Institute for ASD (TRIAD) Center offers a webinar series for managing challenging behaviors that parents will be directed to along with the Autism Speaks Challenging Behavior Toolkit handouts. The TAU period will be 12 weeks in length to match time specifications for the active treatment condition.

Timeline

Start date
2022-02-11
Primary completion
2025-09-22
Completion
2025-09-22
First posted
2021-09-27
Last updated
2025-11-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05056922. Inclusion in this directory is not an endorsement.