Clinical trial NCT06193382: Parent-Child Interaction Therapy (PCIT) for Children With Traumatic Brain Injury (TBI): A Stepped-Care Model
Official title: Parent-Child Interaction Therapy (PCIT) for Children With Traumatic Brain Injury (TBI): A Stepped-Care Model
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Disruptive Behavior
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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)

Primary outcomes:
measure: Change in child behavior problem frequency and severity as measured by the Eyberg Child Behavior Inventory (ECBI) intensity scale
timeFrame: Baseline and week 5
measure: Change in caregiver-perceived child behavior problems as measured by the Eyberg Child Behavior Inventory (ECBI) problem scale
timeFrame: Baseline and week 5
measure: Change in parent stress as measured by the Parenting Stress Index Fourth Edition Short Form (PSI-SF) total score
timeFrame: Baseline and week 5
measure: Change in parent stress as measured by the Parenting Stress Index Fourth Edition Short Form (PSI-SF) Parent Stress (PS) score
timeFrame: Baseline and week 5
measure: 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
timeFrame: Baseline and week 5
measure: 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
timeFrame: Baseline and week 5
measure: Change in parenting skills as measured by the Dyadic Parent-Child Interaction Coding System-Fourth Edition (DPIC-IV)
timeFrame: Baseline and week 5
measure: Treatment satisfaction as measured by the Therapist Attitude Inventory (TAI)
timeFrame: Up to 5 weeks
measure: Number of modules completed by the caregiver
timeFrame: Up to 5 weeks
measure: Number of week homework was completed by the caregiver
timeFrame: Up to 5 weeks
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Up to 5 weeks
measure: Intervention Appropriateness Measure (IAM)
timeFrame: Up to 5 weeks
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Up to 5 weeks
Secondary outcomes:
measure: Change in family functioning as measure by the General Functioning (GF) Scale
timeFrame: Baseline and week 5
measure: Change in child's functioning as measured by the Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Baseline and week 5
measure: Change in child's emotional symptoms as measured by the Strengths and Difficulties Questionnaire (SDQ) emotional symptoms scale
timeFrame: Baseline and week 5
measure: Change in child's conduct problems as measured by the Strengths and Difficulties Questionnaire (SDQ) conduct problems scale
timeFrame: Baseline and week 5
measure: Change in child's hyperactivity/inattention as measured by the Strengths and Difficulties Questionnaire (SDQ) hyperactivity/inattention scale
timeFrame: Baseline and week 5
measure: Change in child's peer relationship problems as measured by the Strengths and Difficulties Questionnaire (SDQ) peer relationship problems scale
timeFrame: Baseline and week 5
measure: Change in child's prosocial behaviors as measured by the Strengths and Difficulties Questionnaire (SDQ) prosocial behavior scale
timeFrame: Baseline and week 5
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Dainelys Garcia, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Jason F Jent, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Jennifer Coto, PhD
role: PRINCIPAL_INVESTIGATOR
References: