Parent-Child Interaction Therapy (PCIT) for Children With Traumatic Brain Injury (TBI): A Stepped-Care Model

NCT ID: NCT06193382

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2026-12-30

Brief Summary

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The purpose of this study is to understand how a stepped-care model of Parent-Child Interaction Therapy (Step-Up PCIT) addresses child behavioral problems among children between the ages of 2 and 7 with a traumatic brain injury (TBI).

Detailed Description

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Conditions

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Traumatic Brain Injury Disruptive Behavior

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PCIT Group

Participants in this group will receive the PCIT intervention for up to 5 weeks.

Group Type EXPERIMENTAL

PCIT

Intervention Type BEHAVIORAL

Participants will receive the adapted Pocket PCIT Online via a web-based learning platform for up to 5 weeks. Participants will engage in this intervention weekly for about 1 hour per week. During engaging with the adapted Pocket PCIT Online version of PCIT, caregivers will learn positive parenting skills to increase the warmth of the parent-child relationship as well as strategies to effectively set limits. Participants will also participate in 15-minute check-in phone calls with a therapist each week throughout the course of treatment.

Interventions

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PCIT

Participants will receive the adapted Pocket PCIT Online via a web-based learning platform for up to 5 weeks. Participants will engage in this intervention weekly for about 1 hour per week. During engaging with the adapted Pocket PCIT Online version of PCIT, caregivers will learn positive parenting skills to increase the warmth of the parent-child relationship as well as strategies to effectively set limits. Participants will also participate in 15-minute check-in phone calls with a therapist each week throughout the course of treatment.

Intervention Type BEHAVIORAL

Other Intervention Names

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Step-Up PCIT Pocket PCIT

Eligibility Criteria

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Inclusion Criteria

* Child is between the ages of 2 and 7
* Child has a mild to moderate TBI


* Primary caregiver is 18 years or older
* Primary caregiver speaks and reads in either English or Spanish

Exclusion Criteria

\- Children with major sensory impairments (e.g., deafness, blindness)


\- Primary caregiver with major sensory impairments (e.g., deafness, blindness)
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Dainelys Garcia

Associate Professor of Clinical Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dainelys Garcia, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Jason F Jent, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Jennifer Coto, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Central Contacts

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Dainelys Garcia, PhD

Role: CONTACT

3052430234

Facility Contacts

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Dainelys Garcia, PhD

Role: primary

305-243-0234

Other Identifiers

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20230405

Identifier Type: -

Identifier Source: org_study_id

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