Menu
Not yet recruiting NCT06193382

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

No phase Interventional Traumatic Brain Injury Disruptive Behavior

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: PCIT.
Who it may be relevant to
Registry conditions: Traumatic Brain Injury, Disruptive Behavior. Basic parameters: from 2 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 →

Overview

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).

Interventions

  • Behavioral 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 ea

Primary outcome measures

  • Change in child behavior problem frequency and severity as measured by the Eyberg Child Behavior Inventory (ECBI) intensity scale [Time frame: Baseline and week 5]
  • Change in caregiver-perceived child behavior problems as measured by the Eyberg Child Behavior Inventory (ECBI) problem scale [Time frame: Baseline and week 5]
  • Change in parent stress as measured by the Parenting Stress Index Fourth Edition Short Form (PSI-SF) total score [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Baseline and week 5]
  • Change in parenting skills as measured by the Dyadic Parent-Child Interaction Coding System-Fourth Edition (DPIC-IV) [Time frame: Baseline and week 5]
  • Treatment satisfaction as measured by the Therapist Attitude Inventory (TAI) [Time frame: Up to 5 weeks]
  • Number of modules completed by the caregiver [Time frame: Up to 5 weeks]
  • Number of week homework was completed by the caregiver [Time frame: Up to 5 weeks]
Secondary outcome measures (7)
  • Change in family functioning as measure by the General Functioning (GF) Scale [Time frame: Baseline and week 5]
  • Change in child's functioning as measured by the Strengths and Difficulties Questionnaire (SDQ) [Time frame: Baseline and week 5]
  • Change in child's emotional symptoms as measured by the Strengths and Difficulties Questionnaire (SDQ) emotional symptoms scale [Time frame: Baseline and week 5]
  • Change in child's conduct problems as measured by the Strengths and Difficulties Questionnaire (SDQ) conduct problems scale [Time frame: Baseline and week 5]
  • Change in child's hyperactivity/inattention as measured by the Strengths and Difficulties Questionnaire (SDQ) hyperactivity/inattention scale [Time frame: Baseline and week 5]
  • Change in child's peer relationship problems as measured by the Strengths and Difficulties Questionnaire (SDQ) peer relationship problems scale [Time frame: Baseline and week 5]
  • Change in child's prosocial behaviors as measured by the Strengths and Difficulties Questionnaire (SDQ) prosocial behavior scale [Time frame: Baseline and week 5]

Eligibility criteria

Child Inclusion Criteria:

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

Primary Caregiver Inclusion Criteria:

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

Child Exclusion Criteria:

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

Primary Caregiver Exclusion Criteria:

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

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

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT06193382 · 20230405

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗