Traumatic Brain Injury Positive Strategies (TIPS)

Brain Injury Support and Strategies for Families Impacted by Childhood TBI

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.

Study Overview

• Status: Completed
• Conditions: Brain Injuries, Traumatic
• Intervention / Treatment: Behavioral: TIPS Intervention; Behavioral: Control

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 Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97403
      • Center on Brain Injury Research and Training / University of Oregon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TIPS Intervention; 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.	Behavioral: TIPS Intervention; Web-based training for family member.
Active Comparator: Control; An existing website related to traumatic brain injury.	Behavioral: Control; Traumatic Brain Injury website for family members.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
PedsQL Cognitive Function	Measures cognitive functioning in patients with acute and chronic health conditions as well as healthy school and community populations.	Baseline
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.

Collaborators and Investigators

• Sponsor: University of Oregon
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Ann Glang, PhD, University of Oregon

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2019
• Primary Completion (Actual): March 6, 2020
• Study Completion (Actual): March 6, 2020

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: March 7, 2019
• First Posted (Actual): March 8, 2019

Study Record Updates

• Last Update Posted (Actual): April 8, 2020
• Last Update Submitted That Met QC Criteria: April 7, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: R44HD059255 (U.S. NIH Grant/Contract); 5R44HD059255-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No