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NCT Number: NCT07225010

Tele-PCIT for Healthy Relationships in Families At-Risk

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.

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Key information

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutledge Tower

Charleston, South Carolina, 29425, United States

Location status: Recruiting

Location contact

Rosmary Ros-Demarize, PhD

CONTACT

[email protected]

843-714-1352

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Tele-PCIT, iPCIT

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.

Other names: Tele-PCIT, iPCIT

Primary outcomes

  1. Parenting Practices

    Time frame: Assessed at Baseline, 12-weeks post baseline, and at a 3-month follow-up

    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.

  2. Child Behavior

    Time frame: Assessed at Baseline, 12-weeks post baseline, and at a 3-month follow-up

    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.

  3. Trauma Related Symptoms

    Time frame: Assessed at Baseline, 12-weeks post baseline, and at a 3-month follow-up

    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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • The Duke Endowment

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 5, 2025
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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