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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06193382
• Other study ID #: 20230405
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: May 30, 2025

Study information

• Verified date: April 2024
• Source: University of Miami
• Contact: Dainelys Garcia, PhD
• Phone: 3052430234
• Email: ngarcia09[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: May 30, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Disruptive Behavior
• Problem Behavior
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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 each week throughout the course of treatment.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of modules completed by the caregiver	Number of modules completed by the caregiver	Up to 5 weeks
Primary	Number of week homework was completed by the caregiver	Number of week homework was completed by the caregiver	Up to 5 weeks
Primary	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
Primary	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
Primary	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	Change in family functioning as measure by the General Functioning (GF) Scale	The general functioning scale is made up of 12 items with six items that reflect healthy family functioning and the other six items reflecting unhealthy functioning. Scoring is on a 4-point scale (from 1 for strongly agree to 4 for strongly disagree) with the scoring for the negatively worded items reversed.	Baseline and week 5
Secondary	Change in child's functioning as measured by the Strengths and Difficulties Questionnaire (SDQ)	SDQ is a brief emotional and behavioral screening questionnaire for children and young people. Scores range from minimal value (not true) to maximum value (certainly true).The scores will be summed to provide a total score.	Baseline and week 5
Secondary	Change in child's emotional symptoms as measured by the Strengths and Difficulties Questionnaire (SDQ) emotional symptoms scale	SDQ is a brief emotional and behavioral screening questionnaire for children and young people. Scores range from minimal value (not true) to maximum value (certainly true).The scores will be summed to provide a total score.	Baseline and week 5
Secondary	Change in child's conduct problems as measured by the Strengths and Difficulties Questionnaire (SDQ) conduct problems scale	SDQ is a brief emotional and behavioral screening questionnaire for children and young people. Scores range from minimal value (not true) to maximum value (certainly true).The scores will be summed to provide a total score.	Baseline and week 5
Secondary	Change in child's hyperactivity/inattention as measured by the Strengths and Difficulties Questionnaire (SDQ) hyperactivity/inattention scale	SDQ is a brief emotional and behavioral screening questionnaire for children and young people. Scores range from minimal value (not true) to maximum value (certainly true).The scores will be summed to provide a total score.	Baseline and week 5
Secondary	Change in child's peer relationship problems as measured by the Strengths and Difficulties Questionnaire (SDQ) peer relationship problems scale	SDQ is a brief emotional and behavioral screening questionnaire for children and young people. Scores range from minimal value (not true) to maximum value (certainly true).The scores will be summed to provide a total score.	Baseline and week 5
Secondary	Change in child's prosocial behaviors as measured by the Strengths and Difficulties Questionnaire (SDQ) prosocial behavior scale	SDQ is a brief emotional and behavioral screening questionnaire for children and young people. Scores range from minimal value (not true) to maximum value (certainly true).The scores will be summed to provide a total score.	Baseline and week 5