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Traumatic Brain Injury Positive Strategies (TIPS)

Primary Purpose

Brain Injuries, Traumatic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TIPS Intervention
Control
Sponsored by
University of Oregon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain Injuries, Traumatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adult 18 years old or older
  • Have a child age 3-18 that was hospitalized overnight with a traumatic brain injury (TBI).
  • Involved in the care and support of the child with the TBI.
  • Live in the same household as child with a TBI.
  • The child with the TBI is able to follow simple instructions such as "please eat your toast."

Exclusion Criteria:

  • Does not speak and read English.
  • Does not have high speed Internet access.
  • Not US resident

Sites / Locations

  • Center on Brain Injury Research and Training / University of Oregon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TIPS Intervention

Control

Arm Description

The Traumatic Brain Injury Positive Strategies (TIPS) program, is a comprehensive educational and training resource to help families. The web-based product will include: (a) the Training Center, which will provide training in a range of evidence-based strategies within a problem-solving framework; and (b) the TBI Resource Center, an extensive library of educational materials, information, and resources about childhood TBI.

An existing website related to traumatic brain injury.

Outcomes

Primary Outcome Measures

TIPS Change in Knowledge Survey
Survey to assess change in knowledge of research-based cognitive, behavioral, and social support strategies and self-efficacy about using those strategies in home and community settings.
PedsQL Family Impact
Administered to measure change in impact of pediatric acute and chronic health conditions on parents and the family.
Caregiver Self-Efficacy Scale
25-question self-report measure, administered to measure the change in how comfortable caregivers feel about selected aspects of their parenting skills such as managing their child's behavior, being an advocate for their child, and dealing with school-related issues.

Secondary Outcome Measures

The Pediatric Quality of Life Inventory (PedsQL)
23 items measuring physical, emotional, social, and school function. Caregiver report forms have been developed for children 2-18 years. The PedsQL has been used in pediatric TBI as a quality of life outcome.
PedsQL Cognitive Function
Measures cognitive functioning in patients with acute and chronic health conditions as well as healthy school and community populations.
Health Behavior Inventory (HBI)
20 items measuring the change in frequency of common brain injury symptoms (somatic, cognitive, and emotional). It will also be used to examine the effectiveness of the interventions in promoting symptom reduction.

Full Information

First Posted
January 17, 2019
Last Updated
April 7, 2020
Sponsor
University of Oregon
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03867968
Brief Title
Traumatic Brain Injury Positive Strategies
Acronym
TIPS
Official Title
Brain Injury Support and Strategies for Families Impacted by Childhood TBI
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 13, 2019 (Actual)
Primary Completion Date
March 6, 2020 (Actual)
Study Completion Date
March 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oregon
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the effectiveness of The Traumatic Brain Injury Positive Strategies (TIPS) program, a comprehensive educational and training resource to help families improve their knowledge and skills in supporting a child with TBI experiencing cognitive, behavioral, and social challenges. The application provides training in evidence-based support strategies with the goal of improving outcomes for children with TBI and their families. Half the participants will receive access to the TIPS program, while the other half will receive access to a different TBI related website.
Detailed Description
Due to the chronic nature of cognitive and behavioral problems related to TBI, parents and other family caregivers need information, resources, and training in evidence-based strategies to manage the varied and changing concerns following their child's injury. Recent research provides evidence that theory-driven, self-directed online parent training is effective in improving both child and parent outcomes. The objective of this project is to produce the Traumatic Brain Injury Positive Strategies (TIPS) program, a comprehensive educational and training resource to help families improve their knowledge and skills to address cognitive, behavioral, and social challenges following pediatric TBI. The TIPS program will be grounded in the theory of planned behavior, which postulates that training in problem-solving leads to improved skills and increases in perceived behavioral control that mediate direct changes in parenting behaviors and indirect changes in child outcomes. The web-based product will include: (a) the Training Center, which will provide training in a range of evidence-based strategies within a problem-solving framework; and (b) the TBI Resource Center, an extensive library of educational materials, information, and resources about childhood TBI. Approximately 216 family members will participate in the evaluation phase of this study. Participants will be randomly assigned to one of two conditions: (a) treatment (TIPS program ) or (b) control (brain injury website).

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
TIPS Intervention
Arm Type
Experimental
Arm Description
The Traumatic Brain Injury Positive Strategies (TIPS) program, is a comprehensive educational and training resource to help families. The web-based product will include: (a) the Training Center, which will provide training in a range of evidence-based strategies within a problem-solving framework; and (b) the TBI Resource Center, an extensive library of educational materials, information, and resources about childhood TBI.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
An existing website related to traumatic brain injury.
Intervention Type
Behavioral
Intervention Name(s)
TIPS Intervention
Intervention Description
Web-based training for family member.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Traumatic Brain Injury website for family members.
Primary Outcome Measure Information:
Title
TIPS Change in Knowledge Survey
Description
Survey to assess change in knowledge of research-based cognitive, behavioral, and social support strategies and self-efficacy about using those strategies in home and community settings.
Time Frame
Baseline , at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
Title
PedsQL Family Impact
Description
Administered to measure change in impact of pediatric acute and chronic health conditions on parents and the family.
Time Frame
Baseline and for a 3 month follow up after completed intervention.
Title
Caregiver Self-Efficacy Scale
Description
25-question self-report measure, administered to measure the change in how comfortable caregivers feel about selected aspects of their parenting skills such as managing their child's behavior, being an advocate for their child, and dealing with school-related issues.
Time Frame
Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
Secondary Outcome Measure Information:
Title
The Pediatric Quality of Life Inventory (PedsQL)
Description
23 items measuring physical, emotional, social, and school function. Caregiver report forms have been developed for children 2-18 years. The PedsQL has been used in pediatric TBI as a quality of life outcome.
Time Frame
Baseline
Title
PedsQL Cognitive Function
Description
Measures cognitive functioning in patients with acute and chronic health conditions as well as healthy school and community populations.
Time Frame
Baseline
Title
Health Behavior Inventory (HBI)
Description
20 items measuring the change in frequency of common brain injury symptoms (somatic, cognitive, and emotional). It will also be used to examine the effectiveness of the interventions in promoting symptom reduction.
Time Frame
Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult 18 years old or older Have a child age 3-18 that was hospitalized overnight with a traumatic brain injury (TBI). Involved in the care and support of the child with the TBI. Live in the same household as child with a TBI. The child with the TBI is able to follow simple instructions such as "please eat your toast." Exclusion Criteria: Does not speak and read English. Does not have high speed Internet access. Not US resident
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Glang, PhD
Organizational Affiliation
University of Oregon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center on Brain Injury Research and Training / University of Oregon
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Traumatic Brain Injury Positive Strategies

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