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Tele-PCIT for Healthy Relationships in Families At-Risk

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07225010
Enrollment
50
Registered
2025-11-05
Start date
2026-02-12
Completion date
2028-08-01
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disruptive Behavior, Pediatrics

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.

Interventions

BEHAVIORALTelehealth 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.

BEHAVIORALTelehealth 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.

Sponsors

Medical University of South Carolina
Lead SponsorOTHER
The Duke Endowment
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Parenting PracticesAssessed at Baseline, 12-weeks post baseline, and at a 3-month follow-upMeasured 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.
Child BehaviorAssessed at Baseline, 12-weeks post baseline, and at a 3-month follow-upMeasured 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.
Trauma Related SymptomsAssessed at Baseline, 12-weeks post baseline, and at a 3-month follow-upMeasured 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRosmary Ros-Demarize, Ph.D.

Medical University of South Carolina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026