Health TrialsbyHealthPanel

Tele-PCIT for Healthy Relationships in Families At-Risk

ConditionsDisruptive BehaviorPediatrics
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-7
SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Tele-PCITExperimental treatment 1 intervention
Group B: Waitlist ControlOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Assessed at Baseline, 12-weeks post baseline, and at a 3-month follow-up
2

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.

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

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

The Duke Endowment

Collaborator

Source ClinicalTrials.gov
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