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

Primary Purpose

Tbi, Intracranial Edema, Brain Edema

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapist Guided Face to Face Family Problem Solving
Therapist Guided Online Family Problem Solving
Self-Guided Online Family Problem Solving
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tbi

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Children's Hospital
  • Cincinnati Children's Hospital Medical Center
  • Case Western Reserve University
  • MetroHealth Medical Center
  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Therapist Guided Face to Face FPST

Therapist Guided Online FPST

Self-Guided Online FPST

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Behavior Rating Inventory of Executive Function (BRIEF)

Secondary Outcome Measures

Center for Epidemiology Scale for Depression (CES-D)
Health and Behavior Inventory (HBI)
Ohio State University (OSU) Traumatic Brain Injury (TBI) Identification Method (OSU TBI-ID)
Brief Symptom Inventory (BSI)
Strengths and Difficulties Questionnaire (SDQ)
Pediatric Quality of Life Inventory (PedsQL)

Full Information

First Posted
October 27, 2014
Last Updated
January 25, 2018
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Case Western Reserve University, Children's Hospital Colorado, MetroHealth Medical Center, Nationwide Children's Hospital, Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02368366
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Case Western Reserve University, Children's Hospital Colorado, MetroHealth Medical Center, Nationwide Children's Hospital, Patient-Centered Outcomes Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapist Guided Face to Face FPST
Arm Type
Experimental
Arm Description
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.
Arm Title
Therapist Guided Online FPST
Arm Type
Experimental
Arm Description
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.
Arm Title
Self-Guided Online FPST
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Therapist Guided Face to Face Family Problem Solving
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Therapist Guided Online Family Problem Solving
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-Guided Online Family Problem Solving
Intervention Description
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.
Primary Outcome Measure Information:
Title
Behavior Rating Inventory of Executive Function (BRIEF)
Time Frame
Baseline, post-intervention and 3 months post-intervention
Secondary Outcome Measure Information:
Title
Center for Epidemiology Scale for Depression (CES-D)
Time Frame
Baseline, post-intervention and 3 months post-intervention
Title
Health and Behavior Inventory (HBI)
Time Frame
Baseline, post-intervention and 3 months post-intervention
Title
Ohio State University (OSU) Traumatic Brain Injury (TBI) Identification Method (OSU TBI-ID)
Time Frame
Baseline
Title
Brief Symptom Inventory (BSI)
Time Frame
Baseline, post-intervention and 3 months post-intervention
Title
Strengths and Difficulties Questionnaire (SDQ)
Time Frame
Baseline, post-intervention and 3 months post-intervention
Title
Pediatric Quality of Life Inventory (PedsQL)
Time Frame
Baseline, post-intervention and 3 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shari Wade, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31556652
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.
Results Reference
derived

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

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