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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how Parent-Child Interaction Therapy (PCIT) can assist children with behavioral issues following a traumatic brain injury (TBI). The focus is on children aged 2 to 7 with mild to moderate TBI. Participants will engage in a specialized PCIT approach over approximately 5 weeks. Families with young children who have experienced TBI and exhibit behavioral changes may find this trial suitable. As an unphased trial, it provides families the chance to contribute to the understanding and enhancement of therapies for young children with 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 prior data suggests that this therapy is safe for children with traumatic brain injury?

Research has shown that Parent-Child Interaction Therapy (PCIT) is generally safe for children and their families. Although specific safety data for children with traumatic brain injury (TBI) is limited, PCIT has been used and studied in various contexts and is well-tolerated. Many studies have found that PCIT can improve children's behavior, indicating it is a helpful and safe method. The studies reviewed reported no serious negative effects, making PCIT a promising option for families considering this therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for traumatic brain injury, which often focus on medication and physical rehabilitation, Parent-Child Interaction Therapy (PCIT) takes a unique approach by emphasizing behavioral and emotional connections. This therapy aims to improve the parent-child relationship, which can be crucial for emotional recovery and cognitive function. Researchers are excited about PCIT because it offers a more holistic way to support recovery, potentially leading to better long-term outcomes by addressing the emotional and psychological needs of both the child and the family.

What evidence suggests that Parent-Child Interaction Therapy is effective for children with traumatic brain injury?

Research has shown that Parent-Child Interaction Therapy (PCIT) can address child behavior problems, including those resulting from traumatic brain injury (TBI). In one study, 71% of families who completed the PCIT program reported improvements in their child's behavior. Another case study found that after 11 PCIT sessions, a child no longer exhibited signs of oppositional defiant disorder, a common behavior issue. PCIT is recognized as an effective treatment for various childhood behavior problems. Overall, studies suggest that PCIT can improve behavior in children with TBI. Participants in this trial will receive the PCIT intervention for up to 5 weeks. ^{2 3 6 7 8}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34015114/

Intensive Parent-Child Interaction Therapy for Children with ... Results: Ten of the 14 families who completed the baseline assessment (71%) completed the intervention and post and follow-up assessments. On ...

2. withpower.com withpower.com/trial/parent-child-interaction-therapy-for-traumatic-brain-injury-a4bab

Parent-Child Interaction Therapy for Traumatic Brain Injury The intervention led to high caregiver satisfaction and significant reductions in child behavior issues, with 71% of families completing the program and showing ...

3. researchgate.net researchgate.net/publication/303509548_Parent-Child_Interaction_Therapy_and_Moderate_Pediatric_Traumatic_Brain_Injury_A_Case_Study

(PDF) Parent–Child Interaction Therapy and Moderate ... Results: Following 11 sessions of PCIT over 7 months, Victoria no longer met diagnostic criteria for oppositional defiant disorder and showed ...

4. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2023.1167937/full

Scientific collaborations and research trends in Parent ... Many studies examining PCIT as a treatment for emotional and behavioral concerns have found promising results. For instance, PCIT has been found to be an ...

5. papelesdelpsicologo.es papelesdelpsicologo.es/English/2943.pdf

A SYSTEMATIC REVIEW OF THE EFFECTIVENESS AND ... The results of this review indicate that PCIT is a well-established treatment for five problems in childhood: behavioral problems, oppositional defiant disorder ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6001211/

Internet-based Interacting Together Everyday, Recovery ... A systematic review of parenting interventions for traumatic brain injury: Child and parent outcomes. J Head Trauma Rehabil 2013; 28(5): 349–360. [DOI] ...

7. journals.lww.com journals.lww.com/10.1097/HTR.0000000000000766

Parent Interventions Improve Behavior After Pediatric... Seven studies met inclusion criteria. All interventions reported improved child behavior after pediatric TBI; however, child and parent factors contributed to ...

8. pcori.org pcori.org/research-results/2013/comparing-online-and-person-family-therapy-teens-traumatic-brain-injury-and-their-parents

Comparing Online and In-Person Family Therapy for Teens ... In this study, the research team wanted to learn if online F-PST was similar to in-person F-PST in reducing the effects of TBI for teens and their parents.