Tele-PCIT for Healthy Relationships in Families At-Risk

Fostering Healthy Relationships Through Tele-PCIT for Families of South Carolina

The study will examine Parent Child Interaction Therapy (PCIT) delivered via telehealth (Tele-PCIT) for young children at risk for adverse childhood experiences and/or trauma exposure.

Study Overview

• Status: Recruiting
• Conditions: Pediatrics; Disruptive Behavior
• Intervention / Treatment: Behavioral: Telehealth Parent Child Interaction Therapy; Behavioral: Telehealth Parent Child Interaction Therapy (Delayed Start)

Detailed Description

This randomized controlled trial evaluates the feasibility, acceptability, engagement, and initial efficacy of time-limited Parent Child Interaction Therapy (PCIT) delivered via telehealth (Tele-PCIT) across 40 young children at risk for adverse childhood experiences and/or trauma exposure. The study compares outcomes between families receiving Tele-PCIT (n = 20) and those assigned to a waitlist control (n = 20). All families will complete baseline, post, and follow-up evaluations to assess child behavioral outcomes, parenting outcomes, and trauma symptoms. In order to be eligible children are between 2 and 7 years of age presenting with behavioral concerns and scoring at-risk on childhood averse events measures.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Rutledge Tower
      • Contact: Rosmary Ros-Demarize, PhD; Phone Number: 843-714-1352; Email: pcitfamilias@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Child participants must:

  • Be between 2:0-6:11 years old
  • Have elevated levels of disruptive behavior problems as defined by the Eyberg Child Behavior Inventory (ECBI)
  • Have receptive language appropriate for PCIT (approximately 2-years old)
  • Medicaid eligible, or be uninsured
  • Score of 1 or greater on an ACEs (adverse childhood experiences) measure (PEARLS)

• Parent participants must:

  • Be the child's legal guardian
  • Be able to provide consent for themselves (i.e., have decision making capacity and do not need a legally authorized representative themselves).
  • Must be living with the child

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Waitlist Control; Delayed Start of Tele-PCIT	Behavioral: Telehealth Parent Child Interaction Therapy (Delayed Start); Delayed start of 12-weeks for delivery of Tele-PCIT. During tele-PCIT, therapists coach parents on parenting strategies while they play with their child during one hour weekly sessions. The first phase of therapy focuses on increasing positive behaviors and the second phase focuses on decreasing negative behaviors with discipline strategies. The therapist and the family will be connected through a video feed on either a phone, tablet, or computer and a Bluetooth headset.; Other Names: Tele-PCIT; iPCIT
Experimental: Tele-PCIT; Families in the Tele-PCIT condition will recieve a time limited (10 session) version of PCIT via telehealth.	Behavioral: Telehealth Parent Child Interaction Therapy; During tele-PCIT, therapists coach parents on parenting strategies while they play with their child during one hour weekly sessions. The first phase of therapy focuses on increasing positive behaviors and the second phase focuses on decreasing negative behaviors with discipline strategies. The therapist and the family will be connected through a video feed on either a phone, tablet, or computer and a Bluetooth headset.; Other Names: Tele-PCIT; iPCIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parenting Practices	Measured by the Parenting Scale. The parenting scale is comprised of 30 items rated 1-7 with specific items being averaged to create composites for Laxness, Verbosity, and Overreactivity. Higher scores on each scale indicate higher levels of each parenting behavior.	Assessed at Baseline, 12-weeks post baseline, and at a 3-month follow-up
Child Behavior	Measured by Eyberg Child Behavior Inventory. The ECBI is comprised of 36 items ranging from 1 to 7 and the overall score has a a minimum of 36 and maximum of 252 with higher scores indicating higher behavioral challenges.	Assessed at Baseline, 12-weeks post baseline, and at a 3-month follow-up
Trauma Related Symptoms	Measured by the Child and Adolescent Trauma Screen. The CATS contains 15 items measuring traumatic events, 20 items measuring DSM-5 PTSD symptoms, and 5 items measuring psychosocial functioning, with a range of 0-48 and higher scores indicating greater symptoms.	Assessed at Baseline, 12-weeks post baseline, and at a 3-month follow-up

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: The Duke Endowment
• Investigators: Principal Investigator: Rosmary Ros-Demarize, Ph.D., Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: November 3, 2025
• First Submitted That Met QC Criteria: November 3, 2025
• First Posted (Actual): November 5, 2025

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Child Behavior; Problem Behavior; RTI 121
• Other Study ID Numbers: Pro00146035; 2167-SP (Other Grant/Funding Number: Duke Endowment)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No