Parent-Child Interaction Therapy for Traumatic Brain Injury

Overseen By Dainelys Garcia, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Major sensory impairments

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

20 Participants Needed

Trial Summary

What is the purpose of 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).

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Parent-Child Interaction Therapy (PCIT) for Traumatic Brain Injury?

Research shows that Parent-Child Interaction Therapy (PCIT) is effective in managing disruptive behavior problems and child physical maltreatment, and it has been applied to help manage behavior issues in children with traumatic brain injury (TBI). A case study and a feasibility study suggest that PCIT can be adapted for children with TBI to help manage their behavior. ^{1 2 3 4 5}

Is Parent-Child Interaction Therapy (PCIT) safe for humans?

Parent-Child Interaction Therapy (PCIT) has been used safely for managing behavior problems in children, including those with traumatic brain injuries and other conditions. While specific safety data for traumatic brain injury is limited, PCIT is generally considered safe for children and families. ^{1 2 3 4 6}

How does Parent-Child Interaction Therapy (PCIT) differ from other treatments for traumatic brain injury?

Parent-Child Interaction Therapy (PCIT) is unique because it focuses on improving the relationship between parents and children through live coaching, which helps manage behavioral issues after a traumatic brain injury. Unlike other treatments that might focus solely on the child, PCIT involves both the parent and child, making it a family-oriented approach. ^{1 2 3 5 7}

Research Team

Dainelys Garcia, PhD

Principal Investigator

University of Miami

Jason Jent, PhD

Principal Investigator

University of Miami

Jennifer Coto, PhD

Principal Investigator

University of Miami

Eligibility Criteria

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.

Inclusion Criteria

My primary caregiver can speak and read English or Spanish.

Child has a mild to moderate TBI

My child is between 2 and 7 years old.

Exclusion Criteria

I am a primary caregiver and have a major sensory impairment.

My child has a major sensory impairment like deafness or blindness.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Parent-Child Interaction Therapy (PCIT) intervention

5 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in child behavior and family functioning

4 weeks

Treatment Details

Interventions

• PCIT

Trial Overview 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.

Participant Groups

Group I: PCIT Group Experimental Treatment 1 Intervention

Participants in this group will receive the PCIT intervention for up to 5 weeks.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Findings from Research

Parent-child interaction therapy (PCIT) was successfully applied to an 11-year-old boy with externalizing behaviors following a severe traumatic brain injury, demonstrating its adaptability beyond the typical age range.

After 9 sessions of PCIT, the child showed a significant reduction in negative behaviors, and his mother experienced less distress, indicating the therapy's effectiveness in improving family dynamics post-injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent-child interaction therapy as a family-oriented approach to behavioral management following pediatric traumatic brain injury: a case report. Cohen, ML., Heaton, SC., Ginn, N., et al.[2012]

A time-limited and intensive format of Parent-Child Interaction Therapy (PCIT) was found feasible for 15 families with young children aged 2-5 years who had experienced a traumatic brain injury (TBI) and exhibited behavior problems.

The intervention led to high caregiver satisfaction and significant reductions in child behavior issues, with 71% of families completing the program and showing improvements at post-assessment and follow-up, suggesting it may effectively address challenges following early childhood TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive Parent-Child Interaction Therapy for Children with Traumatic Brain Injury: Feasibility Study. Garcia, D., Rodríguez, GM., Lorenzo, NE., et al.[2022]

Direct-to-consumer advertisements for Parent-Child Interaction Therapy (PCIT) can effectively influence Spanish-speaking parents' intentions to seek help, especially when the messenger is a therapist rather than a parent.

The study highlights the importance of tailored advertising strategies to improve access to mental health services for racial and ethnic minority families, as Spanish-speaking participants showed varying help-seeking intentions based on the messenger used in the advertisements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct-to-Consumer Marketing for Parent-Child Interaction Therapy: Impact of Language and Messenger. Barnett, ML., Bernal, NA., Luis Sanchez, BE.[2022]

Parent-Child Interaction Therapy (PCIT) is an effective intervention for childhood conduct problems, but its adoption by clinicians in routine care settings is still low despite its proven effectiveness.

This systematic review identified only three studies focused on training clinicians in PCIT, highlighting a need for more research on how to support clinicians in adopting and sustaining the use of PCIT after training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician adoption of Parent-Child Interaction Therapy: A systematic review of implementation interventions. Woodfield, MJ., Merry, S., Hetrick, SE.[2023]

Clinicians trained using the Cascading Model (CM) were more likely to complete their training and reported higher satisfaction and better learning experiences compared to those in other training models.

Supervisors in the Learning Collaborative (LC) condition reported greater knowledge and satisfaction, while Distance Education (DE) produced comparable results in terms of treatment implementation and clinician satisfaction, suggesting that different training methods can be effective in various contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Statewide Randomized Controlled Trial to Compare Three Models for Implementing Parent Child Interaction Therapy. Herschell, AD., Kolko, DJ., Scudder, AT., et al.[2023]

Parent-Child Interaction Therapy (PCIT) is viewed as an effective treatment for conduct problems in young children, but its implementation is limited in New Zealand and Australia due to barriers such as lack of access to necessary equipment and client attendance issues.

Clinicians generally feel less confident in the Parent-Directed Interaction phase, which includes time-out strategies, but concerns about time-out were not the main barrier to implementation; instead, adapting the protocol to include more emotion regulation content was common among those who tailor the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers to Clinician Implementation of Parent-Child Interaction Therapy (PCIT) in New Zealand and Australia: What Role for Time-Out? Woodfield, MJ., Cargo, T., Merry, SN., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Parent-child interaction therapy as a family-oriented approach to behavioral management following pediatric traumatic brain injury: a case report. [2012]

2. United States pubmed.ncbi.nlm.nih.gov

Intensive Parent-Child Interaction Therapy for Children with Traumatic Brain Injury: Feasibility Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Direct-to-Consumer Marketing for Parent-Child Interaction Therapy: Impact of Language and Messenger. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Parenting intervention for externalizing behavior problems in children born premature: an initial examination. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Clinician adoption of Parent-Child Interaction Therapy: A systematic review of implementation interventions. [2023]

6. England pubmed.ncbi.nlm.nih.gov

A Statewide Randomized Controlled Trial to Compare Three Models for Implementing Parent Child Interaction Therapy. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Barriers to Clinician Implementation of Parent-Child Interaction Therapy (PCIT) in New Zealand and Australia: What Role for Time-Out? [2021]