Tele-PCIT for Healthy Relationships in Families At-Risk

NCT ID: NCT07225010

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-08-31

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.

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.

Conditions

Disruptive Behavior; Pediatrics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tele-PCIT

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

Group Type: EXPERIMENTAL

Telehealth Parent Child Interaction Therapy

Intervention Type: 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.

Waitlist Control

Delayed Start of Tele-PCIT

Group Type: OTHER

Telehealth Parent Child Interaction Therapy (Delayed Start)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Tele-PCIT; iPCIT; Tele-PCIT; iPCIT

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Duke Endowment

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Rosmary Ros-Demarize

Associate Professor-Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rosmary Ros-Demarize, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Rutledge Tower

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Rosmary Ros-Demarize, PhD

Role: primary

Other Identifiers

2167-SP

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00146035

Identifier Type: -

Identifier Source: org_study_id