Parent-Child Interaction Therapy (PCIT) for Children With Traumatic Brain Injury (TBI)
This study is looking at how a special type of therapy called Parent-Child Interaction Therapy (PCIT) can help children aged 2 to 7 who have had a traumatic brain injury (TBI) and are experiencing behavior problems. The study will test an online version of PCIT called "Pocket PCIT Online." Caregivers will learn positive parenting techniques over about 5 weeks, with one hour of online engagement per week. Researchers want to see if this therapy can reduce how often and how severe a child's behavior problems are, and also decrease stress for the caregiver. The study aims to enroll 20 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific therapy. It plans to enroll 20 participants.
- What's involved
- Participants will engage with the adapted Pocket PCIT Online via a web-based platform weekly for about 1 hour per week, for up to 5 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Child behavior problems and parent stress will be measured at the beginning of the study and again at week 5.
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Parent-Child Interaction Therapy (PCIT) for Children With Traumatic Brain Injury (TBI): A Stepped-Care Model
At a glance
Conditions
NCT06193382
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Miami
Miami, Floridastudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Dainelys Garcia, PhD · PRINCIPAL_INVESTIGATOR · University of Miami
- Jason F Jent, PhD · PRINCIPAL_INVESTIGATOR · University of Miami
- Jennifer Coto, PhD · PRINCIPAL_INVESTIGATOR · University of Miami
Who to contact
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Inclusion
What this trial measures
- Change in child behavior problem frequency and severity as measured by the Eyberg Child Behavior Inventory (ECBI) intensity scaleBaseline 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.
- Change in caregiver-perceived child behavior problems as measured by the Eyberg Child Behavior Inventory (ECBI) problem scaleBaseline 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.
- Change in parent stress as measured by the Parenting Stress Index Fourth Edition Short Form (PSI-SF) total scoreBaseline 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.
- Change in parent stress as measured by the Parenting Stress Index Fourth Edition Short Form (PSI-SF) Parent Stress (PS) scoreBaseline 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.
- 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) scoreBaseline 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.
- 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) scoreBaseline 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.
- Change in parenting skills as measured by the Dyadic Parent-Child Interaction Coding System-Fourth Edition (DPIC-IV)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.
- Treatment satisfaction as measured by the Therapist Attitude Inventory (TAI)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
- Number of modules completed by the caregiverUp to 5 weeks
Number of modules completed by the caregiver
- Number of week homework was completed by the caregiverUp to 5 weeks
Number of week homework was completed by the caregiver
- Acceptability of Intervention Measure (AIM)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.
- Intervention Appropriateness Measure (IAM)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.
- Feasibility of Intervention Measure (FIM)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.