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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2+
SponsorUniversity of Miami

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: PCIT GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and week 5
2

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.

Time frame
Baseline and week 5
3

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.

Time frame
Baseline and week 5
4

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.

Time frame
Baseline and week 5

Secondary outcomes

1

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.

Time frame
Baseline and week 5
2

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.

Time frame
Baseline and week 5
3

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.

Time frame
Baseline and week 5
4

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.

Time frame
Baseline and week 5

Other outcomes

Sponsors and contacts

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