Comparative Effectiveness of Family Problem-Solving Therapy (F-PST) for Adolescent TBI

Brain Injuries Clinical Trial

Official title:

Comparative Effectiveness of Family Problem-Solving Therapy (F-PST) for Adolescent TBI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02368366
• Other study ID #: CER-1306-02435
• Status: Completed
• Phase: N/A
• First received: October 27, 2014
• Last updated: January 25, 2018
• Start date: November 2014
• Est. completion date: November 2017

Study information

• Verified date: January 2018
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Traumatic brain injury (TBI) is the most common cause of acquired disability in youth and a source of significant morbidity and family burden. Novel behavior problems are among the most common and problematic consequences, yet many youth fail to receive needed psychological services due to lack of identification and access. Linking youth with TBI to effective treatments could improve functional outcomes, reduce family burden, and increase treatment satisfaction. The investigators overarching aim is to compare the effectiveness, feasibility, and acceptability of three formats of family problem solving therapy (F-PST) for improving functional outcomes of complicated mild to severe adolescent TBI: therapist-guided, face-to-face; therapist-guided online; and self-guided, online F-PST.

Description:

Background: Traumatic brain injury (TBI) is the most common cause of acquired disability in youth and a source of significant morbidity and family burden. Novel behavior problems are among the most common and problematic consequences, yet many youth fail to receive needed psychological services due to lack of identification and access. Linking youth with TBI to effective treatments could improve functional outcomes, reduce family burden, and increase treatment satisfaction.

Methods: The investigators overarching aim is to compare the effectiveness, feasibility, and acceptability of three formats of family problem solving therapy (F-PST) for improving functional outcomes of complicated mild to severe adolescent TBI: therapist-guided, face-to-face; therapist-guided online; and self-guided, online F-PST. The efficacy of face-to-face and online F-PST in reducing behavior problems following TBI has been established. However, their comparative acceptability and effectiveness are unknown and it is unclear if families could also benefit from online F-PST without therapist support. To identify which patients benefit most from each intervention, participants will be stratified by distance from the clinic with patients living more than 20 miles or 60 minutes from the clinic randomized to one of the two online arms and others equally randomized among three arms. Patient-reported outcomes pertaining to child, caregiver, and family functioning along with patient treatment preferences will be assessed: prior to treatment initiation, at treatment completion, and at a follow-up 3 months later. Stakeholder input (adolescents with TBI and their caregivers) will guide measurement selection and refinements to the treatment protocols. Each treatment modality consists of 10-14 sessions addressing TBI education, problem-solving, self-regulation, and family communication, but varies in the nature and extent of therapist involvement. Participants will include families of 120 adolescents age 14-18 recruited from four metropolitan TBI centers. Mixed models analyses will be used to examine group differences in improvements in child behavior/functioning, caregiver distress, and family burden. Moderators of comparative effectiveness including socioeconomic status, prior technology use, and patient preferences will be examined.

Anticipated Impact: Results will elucidate the relative effectiveness of face-to-face versus online and self-directed versus therapist-supported online modes of treatment including patient and family preferences. They will also provide information about how these programs can be delivered and disseminated through existing head injury follow-up clinics. These data could potentially be translated to other patient populations of youth with psychological symptoms arising from neurological conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 19 Years

Eligibility

Inclusion Criteria:

• Moderate to severe TBI

• Overnight hospital stay

• English-speaking

• Parent must be willing to provide informed consent

Exclusion Criteria:

• Child does not live with parents or guardian

• Child or parent has history of hospitalization for psychiatric problem

• Child suffered a non-blunt injury (e.g., projectile wound, stroke, drowning, or other form of asphyxiation)

• Diagnosed with moderate or severe mental retardation, autism, or a significant developmental disability

Related Conditions & MeSH terms

• Brain Concussion
• Brain Contusion
• Brain Edema
• Brain Hemorrhage, Traumatic
• Brain Injuries
• Contusions
• Cortical Contusion
• Craniocerebral Trauma
• Disorders of Environmental Origin
• Edema
• Epidural Hematoma
• Head Injuries, Closed
• Head Injury
• Hematoma
• Hemorrhage
• Intracranial Edema
• Intracranial Hemorrhages
• Subdural Hematoma
• Tbi
• Trauma, Nervous System
• Wounds and Injuries

Intervention

Behavioral:
• Therapist Guided Face to Face Family Problem Solving
Families assigned to this arm will meet with the therapist in person at the medical center TBI clinic. Sessions will last approximately 60 minutes and cover didactic content using printed handouts provided as part of a family workbook.
• Therapist Guided Online Family Problem Solving
Families assigned to this arm will receive a password enabling them to access the online intervention materials throughout the course of the intervention. Each session of online F-PST consists of a self-guided online portion providing didactic content regarding the desired skill (i.e., problem-solving), video clips showing individuals and families modeling the skill, and exercises and assignments giving the family an opportunity to practice the skill. During synchronous, videoconference sessions with the therapist, the family will review the online materials and practice the problem-solving process.
• Self-Guided Online Family Problem Solving
Families in the self-guided, online F-PST arm will receive a password enabling them to access the online intervention materials throughout the course of the intervention. They will receive access to the same web-modules as the therapist-guided group, but will review them on their own without therapist support. Participants in this group will be encouraged to complete web modules at the same schedule as participants in the other groups. If the family fails to log on or complete web modules, they will receive reminders via phone, text, or e-mail.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Case Western Reserve University	Cleveland	Ohio
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	The Children's Hospital	Denver	Colorado

Sponsors (6)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Case Western Reserve University, Children's Hospital Colorado, MetroHealth Medical Center, Nationwide Children's Hospital, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavior Rating Inventory of Executive Function (BRIEF)		Baseline, post-intervention and 3 months post-intervention
Secondary	Center for Epidemiology Scale for Depression (CES-D)		Baseline, post-intervention and 3 months post-intervention
Secondary	Health and Behavior Inventory (HBI)		Baseline, post-intervention and 3 months post-intervention
Secondary	Ohio State University (OSU) Traumatic Brain Injury (TBI) Identification Method (OSU TBI-ID)		Baseline
Secondary	Brief Symptom Inventory (BSI)		Baseline, post-intervention and 3 months post-intervention
Secondary	Strengths and Difficulties Questionnaire (SDQ)		Baseline, post-intervention and 3 months post-intervention
Secondary	Pediatric Quality of Life Inventory (PedsQL)		Baseline, post-intervention and 3 months post-intervention