Traumatic Brain Injury Positive Strategies

Brain Injuries, Traumatic Clinical Trial

— TIPS  

Official title:

Brain Injury Support and Strategies for Families Impacted by Childhood TBI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03867968
• Other study ID #: R44HD059255
• Secondary ID: 5R44HD059255-04
• Status: Completed
• Phase: N/A
• Start date: February 13, 2019
• Est. completion date: March 6, 2020

Study information

• Verified date: April 2020
• Source: University of Oregon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: March 6, 2020
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Wounds and Injuries

Intervention

Behavioral:
• TIPS Intervention
Web-based training for family member.
• Control
Traumatic Brain Injury website for family members.

Locations

Country	Name	City	State
United States	Center on Brain Injury Research and Training / University of Oregon	Eugene	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
University of Oregon	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline , at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
Primary	PedsQL Family Impact	Administered to measure change in impact of pediatric acute and chronic health conditions on parents and the family.	Baseline and for a 3 month follow up after completed intervention.
Primary	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.	Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.
Secondary	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.	Baseline
Secondary	PedsQL Cognitive Function	Measures cognitive functioning in patients with acute and chronic health conditions as well as healthy school and community populations.	Baseline
Secondary	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.	Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.