Clinical trial NCT02368366: Comparative Effectiveness of Family Problem-Solving Therapy (F-PST) for Adolescent TBI
Official title: Comparative Effectiveness of Family Problem-Solving Therapy (F-PST) for Adolescent TBI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
name: Children's Hospital Colorado
name: MetroHealth Medical Center
name: Nationwide Children's Hospital
name: Patient-Centered Outcomes Research Institute
First posted: 2015-02-23
Enrollment: 151
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Behavior Rating Inventory of Executive Function (BRIEF)
timeFrame: Baseline, post-intervention and 3 months post-intervention
Secondary outcomes:
measure: Center for Epidemiology Scale for Depression (CES-D)
timeFrame: Baseline, post-intervention and 3 months post-intervention
measure: Health and Behavior Inventory (HBI)
timeFrame: Baseline, post-intervention and 3 months post-intervention
measure: Ohio State University (OSU) Traumatic Brain Injury (TBI) Identification Method (OSU TBI-ID)
timeFrame: Baseline
measure: Brief Symptom Inventory (BSI)
timeFrame: Baseline, post-intervention and 3 months post-intervention
measure: Strengths and Difficulties Questionnaire (SDQ)
timeFrame: Baseline, post-intervention and 3 months post-intervention
measure: Pediatric Quality of Life Inventory (PedsQL)
timeFrame: Baseline, post-intervention and 3 months post-intervention
Other outcomes:
Locations:
city: Denver
country: United States
facility: The Children's Hospital
state: Colorado
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Shari Wade, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wade SL, Cassedy AE, Taylor HG, McNally KA, Kirkwood MW, Stancin T, Horn PS, Kurowski BG. Adolescent quality of life following family problem-solving treatment for brain injury. J Consult Clin Psychol. 2019 Nov;87(11):1043-1055. doi: 10.1037/ccp0000440. Epub 2019 Sep 26.