Tele-PCIT for Healthy Relationships in Families At-Risk

NCT07225010 | Recruiting

• 2 other identifiers: Pro001460352167-SP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Disruptive Behavior; Pediatrics

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Tele-PCIT

EXPERIMENTAL

Families in the Tele-PCIT condition will recieve a time limited (10 session) version of PCIT via telehealth.

Behavioral: Telehealth Parent Child Interaction Therapy

Waitlist Control

OTHER

Delayed Start of Tele-PCIT

Behavioral: Telehealth Parent Child Interaction Therapy (Delayed Start)

Interventions

Telehealth Parent Child Interaction Therapy BEHAVIORAL

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.

Also known as: Tele-PCIT, iPCIT

Tele-PCIT

Telehealth Parent Child Interaction Therapy (Delayed Start) BEHAVIORAL

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.

Also known as: Tele-PCIT, iPCIT

Waitlist Control

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• The Duke Endowment: collaborator
• Medical University of South Carolina: lead

Study Sites (1)

Rutledge Tower

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Problem Behavior

Interventions

RTI 121

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior

Study Officials

• Rosmary Ros-Demarize, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-Faculty

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 5, 2025
• Study Start: February 12, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)