Comparative Effectiveness of Family Problem-Solving Therapy (F-PST) for Adolescent TBI
Condition: 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
MeSH terms: Brain Injuries; Craniocerebral Trauma; Hematoma, Subdural; Brain Concussion; Brain Edema; Intracranial Hemorrhages; Trauma, Nervous System; Hematoma, Epidural, Cranial; Head Injuries, Closed; Brain Hemorrhage, Traumatic; Brain Contusion; Disorders of Environmental Origin; Hemorrhage; Edema; Hematoma; Hematoma, Epidural, Spinal; Wounds and Injuries; Contusions
Study type: Interventional

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.
    

Intervention name(s): Therapist Guided Face to Face Family Problem Solving; Therapist Guided Online Family Problem Solving; Self-Guided Online Family Problem Solving
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment