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Behavioral Intervention
Parent-Child Interaction Therapy for Traumatic Brain Injury
N/A
Waitlist Available
Led By Jennifer Coto, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Child is between the ages of 2 and 7
Must not have
Primary caregiver with major sensory impairments (e.g., deafness, blindness)
Children with major sensory impairments (e.g., deafness, blindness)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to investigate how a specific therapy called Step-Up PCIT can help children between the ages of 2 and 7 who have experienced a traumatic brain injury. The goal is to understand how
Who is the study for?
This trial is for children aged 2-7 who have experienced a traumatic brain injury (TBI) and are showing disruptive behaviors. Specific eligibility criteria were not provided, so additional details such as health status or previous treatments may apply.
What is being tested?
The study is testing Step-Up PCIT, a therapy focused on improving parent-child interactions to help manage behavioral issues in young children with TBI. The 'stepped-care' approach likely means the treatment intensity increases based on need.
What are the potential side effects?
Since PCIT is a form of behavioral therapy involving coaching parents in managing their child's behavior, it does not involve medication; therefore, traditional side effects are not expected. However, stress or emotional discomfort could occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is between 2 and 7 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am a primary caregiver and have a major sensory impairment.
Select...
My child has a major sensory impairment like deafness or blindness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability of Intervention Measure (AIM)
Change in caregiver-perceived child behavior problems as measured by the Eyberg Child Behavior Inventory (ECBI) problem scale
Change in child behavior problem frequency and severity as measured by the Eyberg Child Behavior Inventory (ECBI) intensity scale
+10 moreSecondary study objectives
Change in child's conduct problems as measured by the Strengths and Difficulties Questionnaire (SDQ) conduct problems scale
Change in child's emotional symptoms as measured by the Strengths and Difficulties Questionnaire (SDQ) emotional symptoms scale
Change in child's functioning as measured by the Strengths and Difficulties Questionnaire (SDQ)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: PCIT GroupExperimental Treatment1 Intervention
Participants in this group will receive the PCIT intervention for up to 5 weeks.
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
950 Previous Clinical Trials
428,335 Total Patients Enrolled
Jennifer Coto, PhDPrincipal InvestigatorUniversity of Miami
Jason F Jent, PhDPrincipal InvestigatorUniversity of Miami
Dainelys Garcia, PhDPrincipal InvestigatorUniversity of Miami