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Recruiting NCT07225010

Tele-PCIT for Healthy Relationships in Families At-Risk

No phase Interventional Disruptive Behavior Pediatrics

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Telehealth Parent Child Interaction Therapy, Telehealth Parent Child Interaction Therapy (Delayed Start).
Who it may be relevant to
Registry conditions: Disruptive Behavior, Pediatrics. Basic parameters: 2 years — 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.
  • 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.

Primary outcome measures

  • Parenting Practices [Time frame: Assessed at Baseline, 12-weeks post baseline, and at a 3-month follow-up]
  • Child Behavior [Time frame: Assessed at Baseline, 12-weeks post baseline, and at a 3-month follow-up]
  • Trauma Related Symptoms [Time frame: Assessed at Baseline, 12-weeks post baseline, and at a 3-month follow-up]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Rutledge Tower — Charleston

Identifiers

NCT: NCT07225010 · Pro00146035 · 2167-SP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗