Brain Injuries Clinical Trial
Official title:
Comparative Effectiveness of Family Problem-Solving Therapy (F-PST) for Adolescent TBI
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.
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.
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