Traumatic Brain Injury Positive Strategies

NCT03867968 | Completed

• 2 other identifiers: R44HD0592555R44HD059255-04
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries, Traumatic

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• The Pediatric Quality of Life Inventory (PedsQL)

  Baseline

• 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.

Study Arms (2)

TIPS Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

An existing website related to traumatic brain injury.

Behavioral: Control

Interventions

TIPS Intervention BEHAVIORAL

Web-based training for family member.

TIPS Intervention

Control BEHAVIORAL

Traumatic Brain Injury website for family members.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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."

You may not qualify if:

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

Sponsors & Collaborators

• University of Oregon: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Center on Brain Injury Research and Training / University of Oregon

Eugene, Oregon, 97403, United States

Location

Related Publications (1)

• Karns CM, Wade SL, Slocumb J, Keating T, Gau JM, Slomine BS, Suskauer SJ, Glang A. Traumatic Brain Injury Positive Strategies for Families: A Pilot Randomized Controlled Trial of an Online Parent-Training Program. Arch Phys Med Rehabil. 2023 Jul;104(7):1026-1034. doi: 10.1016/j.apmr.2023.03.013. Epub 2023 May 2.

  PMID: 37142177 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Ann Glang, PhD

  University of Oregon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: March 8, 2019
• Study Start: February 13, 2019
• Primary Completion: March 6, 2020
• Study Completion: March 6, 2020
• Last Updated: April 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)