Comparative Effectiveness of Family Problem-Solving Therapy (F-PST) for Adolescent TBI
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tbi
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Enrollment
- 151
- Locations
- 5
- Primary Endpoint
- Behavior Rating Inventory of Executive Function (BRIEF)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Behavior Rating Inventory of Executive Function (BRIEF)
Time Frame: Baseline, post-intervention and 3 months post-intervention
Secondary Outcomes
- Health and Behavior Inventory (HBI)(Baseline, post-intervention and 3 months post-intervention)
- Brief Symptom Inventory (BSI)(Baseline, post-intervention and 3 months post-intervention)
- Center for Epidemiology Scale for Depression (CES-D)(Baseline, post-intervention and 3 months post-intervention)
- Ohio State University (OSU) Traumatic Brain Injury (TBI) Identification Method (OSU TBI-ID)(Baseline)
- Strengths and Difficulties Questionnaire (SDQ)(Baseline, post-intervention and 3 months post-intervention)
- Pediatric Quality of Life Inventory (PedsQL)(Baseline, post-intervention and 3 months post-intervention)