Traumatic Brain Injury Positive Strategies

NCT ID: NCT03867968

Last Updated: 2020-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-13

Study Completion Date

2020-03-06

Brief Summary

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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

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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).

Conditions

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Brain Injuries, Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

TIPS Intervention

Intervention Type BEHAVIORAL

Web-based training for family member.

Control

An existing website related to traumatic brain injury.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type BEHAVIORAL

Traumatic Brain Injury website for family members.

Interventions

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TIPS Intervention

Web-based training for family member.

Intervention Type BEHAVIORAL

Control

Traumatic Brain Injury website for family members.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Oregon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ann Glang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oregon

Locations

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Center on Brain Injury Research and Training / University of Oregon

Eugene, Oregon, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37142177 (View on PubMed)

Other Identifiers

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5R44HD059255-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R44HD059255

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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