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

NCT06193382 | Not Yet Recruiting

• 1 other identifier: 20230405
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Traumatic Brain Injury; Disruptive Behavior

Outcome Measures

Primary Outcomes (13)

• Change in child behavior problem frequency and severity as measured by the Eyberg Child Behavior Inventory (ECBI) intensity scale

  The ECBI questionnaire will be used to evaluate the number of behavioral problems and the frequency of their occurrence before and after the intervention program. ECBI provides a list of 36 problem behaviors commonly reported by parents. The inventory assesses behavior on two dimensions: 1) the frequency of the behavior; 2) whether parents consider it a problem. The frequency ratings range from 1 (never) to 7 (always), and are summed up to arrive at an overall problem behavior Intensity Score, ranging from 36 to 252. Higher score means more behavioral problems.

  Baseline and week 5

• Change in caregiver-perceived child behavior problems as measured by the Eyberg Child Behavior Inventory (ECBI) problem scale

  The ECBI questionnaire will be used to evaluate the number of behavioral problems and the frequency of their occurrence before and after the intervention program. ECBI provides a list of 36 problem behaviors commonly reported by parents. The inventory assesses behavior on two dimensions: 1) the frequency of the behavior; 2) whether parents consider it a problem. The frequency ratings range from 1 (never) to 7 (always), and are summed up to arrive at an overall problem behavior Intensity Score, ranging from 36 to 252. Higher score means more behavioral problems.

  Baseline and week 5

• Change in parent stress as measured by the Parenting Stress Index Fourth Edition Short Form (PSI-SF) total score

  PSI-4-SF assesses the parents stress level. PSI-4-SF contains 36 items: 12 items for Parental Stress (PS), 12 items for Parent-Child Dysfunctional Interaction (P-CDI), and 12 items for Difficult Child (DC).The normal range for scores is within the 16th to 84th percentiles.Scores in the 85th to 89th percentile are considered high, and scores in the 90th percentile or higher are considered clinically significant.

  Baseline and week 5

• Change in parent stress as measured by the Parenting Stress Index Fourth Edition Short Form (PSI-SF) Parent Stress (PS) score

  PSI-4-SF assesses the parents stress level.PSI-4-SF contains 36 items: 12 items for Parental Stress (PS) , 12 items for Parent-Child Dysfunctional Interaction (P-CDI), and 12 items for Difficult Child (DC).The normal range for scores is within the 16th to 84th percentiles.Scores in the 85th to 89th percentile are considered high, and scores in the 90th percentile or higher are considered clinically significant.

  Baseline and week 5

• Change in parent-child dysfunctional interaction as measured by the Parenting Stress Index Fourth Edition Short Form (PSI-SF) Parent-Child Dysfunctional Interaction (P-CDI) score

  PSI-4-SF assesses the parents stress level.PSI-4-SF contains 36 items: 12 items for Parental Stress (PS) , 12 items for Parent-Child Dysfunctional Interaction (P-CDI), and 12 items for Difficult Child (DC).The normal range for scores is within the 16th to 84th percentiles.Scores in the 85th to 89th percentile are considered high, and scores in the 90th percentile or higher are considered clinically significant.

  Baseline and week 5

• Change in how the caregiver perceptions about how it is to care for the child as measured by the Parenting Stress Index Fourth Edition Short Form (PSI-SF) Difficult Child (DC) score

  PSI-4-SF assesses the parents stress level.PSI-4-SF contains 36 items: 12 items for Parental Stress (PS) , 12 items for Parent-Child dysfunctional Interaction (P-CDI), and 12 items for Difficult Child (DC).The normal range for scores is within the 16th to 84th percentiles.Scores in the 85th to 89th percentile are considered high,and scores in the 90th percentile or higher are considered clinically significant.

  Baseline and week 5

• Change in parenting skills as measured by the Dyadic Parent-Child Interaction Coding System-Fourth Edition (DPIC-IV)

  The Dyadic Parent-Child Interaction Coding System-4th Ed is a structured behavioral observation coding system assessing caregiver-child interactions. Observed parenting behaviors will be coded during a 5-min parent-child play session with a tablet with educational apps and combined into two categories of positive (praises, behavior descriptions, and reflections) and negative (questions, commands, and negative talk) verbalizations, reflecting behaviors caregivers are taught to use and avoid in PCIT. The higher the score the higher quality the parenting behavior.

  Baseline and week 5

• Treatment satisfaction as measured by the Therapist Attitude Inventory (TAI)

  TAI is a valid index of consumer satisfaction for participants in behavioral parent training (BPT). Items are rated on a scale from one (indicating treatment dissatisfaction or lack of improvement) to five (indicating satisfaction with treatment and improvement). Parents will complete this form after the last session of the BPT program. BPT consists of 11 items that are scored on a 5-point Likert scale. The total score range is 11-55; the higher the score, the greater the satisfaction

  Up to 5 weeks

• Number of modules completed by the caregiver

  Number of modules completed by the caregiver

  Up to 5 weeks

• Number of week homework was completed by the caregiver

  Number of week homework was completed by the caregiver

  Up to 5 weeks

• Acceptability of Intervention Measure (AIM)

  The Likert scale has 4 items. The scores will be summed to provide a total score. Scores range from completely disagree to completely agree.

  Up to 5 weeks

• Intervention Appropriateness Measure (IAM)

  The Likert scale has 4 items. The scores will be summed to provide a total score. Scores range from completely disagree to completely agree.

  Up to 5 weeks

• Feasibility of Intervention Measure (FIM)

  The Likert scale has 4 items. The scores will be summed to provide a total score. Scores range from completely disagree to completely agree.

  Up to 5 weeks

Secondary Outcomes (7)

• Change in family functioning as measure by the General Functioning (GF) Scale

  Baseline and week 5

• Change in child's functioning as measured by the Strengths and Difficulties Questionnaire (SDQ)

  Baseline and week 5

• Change in child's emotional symptoms as measured by the Strengths and Difficulties Questionnaire (SDQ) emotional symptoms scale

  Baseline and week 5

• Change in child's conduct problems as measured by the Strengths and Difficulties Questionnaire (SDQ) conduct problems scale

  Baseline and week 5

• Change in child's hyperactivity/inattention as measured by the Strengths and Difficulties Questionnaire (SDQ) hyperactivity/inattention scale

  Baseline and week 5

Study Arms (1)

PCIT Group

EXPERIMENTAL

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

Behavioral: PCIT

Interventions

PCIT 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.

Also known as: Step-Up PCIT, Pocket PCIT

PCIT Group

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Problem Behavior

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Behavioral Symptoms; Behavior; Child Behavior

Study Officials

• Dainelys Garcia, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Jason F Jent, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Jennifer Coto, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dainelys Garcia, PhD

CONTACT

3052430234; ngarcia09@med.miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Pediatrics

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)