Brain Injury Support and Strategies for Families Impacted by Childhood TBI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Oregon
- Enrollment
- 132
- Locations
- 2
- Primary Endpoint
- PedsQL Family Impact
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
PedsQL Family Impact
Time Frame: Baseline and for a 3 month follow up after completed intervention.
Administered to measure change in impact of pediatric acute and chronic health conditions on parents and the family.
Caregiver Self-Efficacy Scale
Time Frame: Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
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.
TIPS Change in Knowledge Survey
Time Frame: Baseline , at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
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.
Secondary Outcomes
- PedsQL Cognitive Function(Baseline)
- Health Behavior Inventory (HBI)(Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.)
- The Pediatric Quality of Life Inventory (PedsQL)(Baseline)