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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02368366 on ClinicalTrials.gov