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

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ClinicalTrials.gov Identifier: NCT02368366
Recruitment Status : Completed
First Posted : February 23, 2015
Last Update Posted : January 29, 2018
Sponsor:
Collaborators:
Case Western Reserve University
Children's Hospital Colorado
MetroHealth Medical Center
Nationwide Children's Hospital
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.

Condition or disease Intervention/treatment Phase
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 Behavioral: Therapist Guided Face to Face Family Problem Solving Behavioral: Therapist Guided Online Family Problem Solving Behavioral: Self-Guided Online Family Problem Solving Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Effectiveness of Family Problem-Solving Therapy (F-PST) for Adolescent TBI
Study Start Date : November 2014
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Arm Intervention/treatment
Experimental: Therapist Guided Face to Face FPST
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
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.

Experimental: Therapist Guided Online FPST
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
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.

Experimental: Self-Guided Online FPST
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 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 Measures :
  1. Behavior Rating Inventory of Executive Function (BRIEF) [ Time Frame: Baseline, post-intervention and 3 months post-intervention ]

Secondary Outcome Measures :
  1. Center for Epidemiology Scale for Depression (CES-D) [ Time Frame: Baseline, post-intervention and 3 months post-intervention ]
  2. Health and Behavior Inventory (HBI) [ Time Frame: Baseline, post-intervention and 3 months post-intervention ]
  3. Ohio State University (OSU) Traumatic Brain Injury (TBI) Identification Method (OSU TBI-ID) [ Time Frame: Baseline ]
  4. Brief Symptom Inventory (BSI) [ Time Frame: Baseline, post-intervention and 3 months post-intervention ]
  5. Strengths and Difficulties Questionnaire (SDQ) [ Time Frame: Baseline, post-intervention and 3 months post-intervention ]
  6. Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: Baseline, post-intervention and 3 months post-intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02368366


Locations
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United States, Colorado
The Children's Hospital
Denver, Colorado, United States, 80045
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Case Western Reserve University
Cleveland, Ohio, United States, 44106
MetroHealth Medical Center
Cleveland, Ohio, United States, 44106
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Case Western Reserve University
Children's Hospital Colorado
MetroHealth Medical Center
Nationwide Children's Hospital
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Shari Wade, PhD Children's Hospital Medical Center, Cincinnati

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02368366    
Other Study ID Numbers: CER-1306-02435
First Posted: February 23, 2015    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Brain Injuries
Craniocerebral Trauma
Hematoma, Subdural
Brain Concussion
Brain Edema
Intracranial Hemorrhages
Trauma, Nervous System
Head Injuries, Closed
Brain Hemorrhage, Traumatic
Brain Contusion
Hemorrhage
Edema
Hematoma
Contusions
Wounds and Injuries
Disorders of Environmental Origin
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Intracranial Hemorrhage, Traumatic
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Brain Injuries, Traumatic
Wounds, Nonpenetrating