Comparative Effectiveness of Family Problem-Solving Therapy (F-PST) for Adolescent TBI
NCT02368366 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151
Last updated 2018-01-29
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.
Conditions
- Tbi
- Intracranial Edema
- Brain Edema
- Craniocerebral Trauma
- Head Injury
- Brain Hemorrhage, Traumatic
- Subdural Hematoma
- Brain Concussion
- Head Injuries, Closed
- Epidural Hematoma
- Cortical Contusion
- Wounds and Injuries
- Disorders of Environmental Origin
- Trauma, Nervous System
- Brain Injuries
Interventions
- 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.
- BEHAVIORAL
-
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.
- BEHAVIORAL
-
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.
Sponsors & Collaborators
-
Case Western Reserve University
collaborator OTHER -
Children's Hospital Colorado
collaborator OTHER -
MetroHealth Medical Center
collaborator OTHER -
Nationwide Children's Hospital
collaborator OTHER -
Patient-Centered Outcomes Research Institute
collaborator OTHER -
Children's Hospital Medical Center, Cincinnati
lead OTHER
Principal Investigators
-
Shari Wade, PhD · Children's Hospital Medical Center, Cincinnati
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 14 Years
- Max Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-11-30
- Primary Completion
- 2017-11-30
- Completion
- 2017-11-30
Countries
- United States
Study Locations
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