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NCT Number: NCT06193382

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

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).

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Key information

Conditions

Traumatic Brain Injury Behavior Behavioral Symptoms Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Child Behavior Craniocerebral Trauma Disruptive Behavior Nervous System Diseases Problem Behavior Trauma, Nervous System Wounds and Injuries

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location contact

Dainelys Garcia, PhD

CONTACT

[email protected]

305-243-0234

Dainelys Garcia, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Step-Up PCIT, Pocket PCIT

Primary outcomes

  1. 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

    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.

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

    Time frame: Baseline and week 5

    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.

  3. 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

    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.

  4. 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

    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.

  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

    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.

  6. 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

    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.

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

    Time frame: Baseline and week 5

    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.

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

    Time frame: Up to 5 weeks

    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

  9. Number of modules completed by the caregiver

    Time frame: Up to 5 weeks

    Number of modules completed by the caregiver

  10. Number of week homework was completed by the caregiver

    Time frame: Up to 5 weeks

    Number of week homework was completed by the caregiver

  11. Acceptability of Intervention Measure (AIM)

    Time frame: Up to 5 weeks

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

  12. Intervention Appropriateness Measure (IAM)

    Time frame: Up to 5 weeks

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

  13. Feasibility of Intervention Measure (FIM)

    Time frame: Up to 5 weeks

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

Secondary outcomes

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

    Time frame: Baseline and week 5

    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.

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

    Time frame: Baseline and week 5

    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.

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

    Time frame: Baseline and week 5

    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.

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

    Time frame: Baseline and week 5

    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.

  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

    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.

  6. 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

    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.

  7. Change in child's prosocial behaviors as measured by the Strengths and Difficulties Questionnaire (SDQ) prosocial behavior scale

    Time frame: Baseline and week 5

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dainelys Garcia, PhD

CONTACT

[email protected]

3052430234

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 5, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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