An interventional study of Therapist Guided Face to Face Family Problem Solving and Therapist Guided Online Family Problem Solving in Tbi, Intracranial Edema and Brain Edema, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 5 sites in United States. Open to participants aged 14 Years to 19 Years. Per ClinicalTrials.gov, last updated 2018-01-29.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Therapist Guided Face to Face Family Problem Solving 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.
Behavioral: Therapist Guided Face to Face Family Problem Solving
Therapist Guided Online Family Problem Solving 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.
Behavioral: Therapist Guided Online Family Problem Solving
Self-Guided Online Family Problem Solving 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.
Behavioral: Self-Guided Online Family Problem Solving
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.
Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: Baseline, post-intervention and 3 months post-intervention
Center for Epidemiology Scale for Depression (CES-D)
Time frame: Baseline, post-intervention and 3 months post-intervention
Health and Behavior Inventory (HBI)
Time frame: Baseline, post-intervention and 3 months post-intervention
Ohio State University (OSU) Traumatic Brain Injury (TBI) Identification Method (OSU TBI-ID)
Time frame: Baseline
Brief Symptom Inventory (BSI)
Time frame: Baseline, post-intervention and 3 months post-intervention
Strengths and Difficulties Questionnaire (SDQ)
Time frame: Baseline, post-intervention and 3 months post-intervention
Pediatric Quality of Life Inventory (PedsQL)
Time frame: Baseline, post-intervention and 3 months post-intervention
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Children's Hospital Medical Center, Cincinnati