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



Status:Completed
Conditions:Cardiology, Hospital, Neurology, Neurology, Neurology, Neurology, Orthopedic
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology, Orthopedics / Podiatry, Other
Healthy:No
Age Range:14 - 19
Updated:1/31/2018
Start Date:November 2014
End Date:November 2017

Use our guide to learn which trials are right for you!

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.

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
We found this trial at
5
sites
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Shari L Wade, PhD
Phone: 513-636-9631
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Kelly McNally, PhD
Phone: 614-355-3471
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
?
mi
from
Columbus, OH
Click here to add this to my saved trials
10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Principal Investigator: H. Gerry Taylor, PhD
Phone: 216-368-5767
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
Phone: 216-778-4917
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Denver, Colorado 80218
Principal Investigator: Michael Kirkwood, PhD
Phone: 720-777-5896
?
mi
from
Denver, CO
Click here to add this to my saved trials