Comparative Effectiveness of Family Problem-Solving Therapy (F-PST) for Adolescent TBI
1 other identifier
interventional
151
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2014
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedFirst Posted
Study publicly available on registry
February 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedJanuary 29, 2018
January 1, 2018
3 years
October 27, 2014
January 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Behavior Rating Inventory of Executive Function (BRIEF)
Baseline, post-intervention and 3 months post-intervention
Secondary Outcomes (6)
Center for Epidemiology Scale for Depression (CES-D)
Baseline, post-intervention and 3 months post-intervention
Health and Behavior Inventory (HBI)
Baseline, post-intervention and 3 months post-intervention
Ohio State University (OSU) Traumatic Brain Injury (TBI) Identification Method (OSU TBI-ID)
Baseline
Brief Symptom Inventory (BSI)
Baseline, post-intervention and 3 months post-intervention
Strengths and Difficulties Questionnaire (SDQ)
Baseline, post-intervention and 3 months post-intervention
- +1 more secondary outcomes
Study Arms (3)
Therapist Guided Face to Face FPST
EXPERIMENTALTherapist 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.
Therapist Guided Online FPST
EXPERIMENTALTherapist 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.
Self-Guided Online FPST
EXPERIMENTALSelf-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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Moderate to severe TBI
- Overnight hospital stay
- English-speaking
- Parent must be willing to provide informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital Medical Center, Cincinnatilead
- Case Western Reserve Universitycollaborator
- Children's Hospital Coloradocollaborator
- MetroHealth Medical Centercollaborator
- Nationwide Children's Hospitalcollaborator
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (5)
The Children's Hospital
Denver, Colorado, 80045, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
MetroHealth Medical Center
Cleveland, Ohio, 44106, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Related Publications (1)
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.
PMID: 31556652DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shari Wade, PhD
Children's Hospital Medical Center, Cincinnati
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2014
First Posted
February 23, 2015
Study Start
November 1, 2014
Primary Completion
November 1, 2017
Study Completion
November 1, 2017
Last Updated
January 29, 2018
Record last verified: 2018-01