Clinical trial NCT03867968: Traumatic Brain Injury Positive Strategies
Official title: Brain Injury Support and Strategies for Families Impacted by Childhood TBI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries, Traumatic
Lead sponsor: University of Oregon
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-03-08
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: TIPS Change in Knowledge Survey
timeFrame: Baseline , at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
measure: PedsQL Family Impact
timeFrame: Baseline and for a 3 month follow up after completed intervention.
measure: Caregiver Self-Efficacy Scale
timeFrame: Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
Secondary outcomes:
measure: The Pediatric Quality of Life Inventory (PedsQL)
timeFrame: Baseline
measure: PedsQL Cognitive Function
timeFrame: Baseline
measure: Health Behavior Inventory (HBI)
timeFrame: Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Center on Brain Injury Research and Training / University of Oregon
state: Oregon
Study officials:
affiliation: University of Oregon
name: Ann Glang, PhD
role: PRINCIPAL_INVESTIGATOR
References: