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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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
Sponsor: Children's Hospital Medical Center, Cincinnati

Current Primary Outcome: Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: Baseline, post-intervention and 3 months post-intervention ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Center for Epidemiology Scale for Depression (CES-D) [ Time Frame: Baseline, post-intervention and 3 months post-intervention ]
  • Health and Behavior Inventory (HBI) [ Time Frame: Baseline, post-intervention and 3 months post-intervention ]
  • Ohio State University (OSU) Traumatic Brain Injury (TBI) Identification Method (OSU TBI-ID) [ Time Frame: Baseline ]
  • Brief Symptom Inventory (BSI) [ Time Frame: Baseline, post-intervention and 3 months post-intervention ]
  • Strengths and Difficulties Questionnaire (SDQ) [ Time Frame: Baseline, post-intervention and 3 months post-intervention ]
  • Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: Baseline, post-intervention and 3 months post-intervention ]


Original Secondary Outcome: Same as current

Information By: Children's Hospital Medical Center, Cincinnati

Dates:
Date Received: October 27, 2014
Date Started: November 2014
Date Completion: September 2017
Last Updated: July 25, 2016
Last Verified: July 2016