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Completed

NCT Number: NCT03867968

Traumatic Brain Injury Positive Strategies

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center on Brain Injury Research and Training / University of Oregon

Eugene, Oregon, 97403, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TIPS Intervention

Behavioral

Web-based training for family member.

Control

Behavioral

Traumatic Brain Injury website for family members.

Primary outcomes

  1. TIPS Change in Knowledge Survey

    Time frame: Baseline , at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.

    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.

  2. PedsQL Family Impact

    Time frame: Baseline and for a 3 month follow up after completed intervention.

    Administered to measure change in impact of pediatric acute and chronic health conditions on parents and the family.

  3. Caregiver Self-Efficacy Scale

    Time frame: Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.

    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.

Secondary outcomes

  1. The Pediatric Quality of Life Inventory (PedsQL)

    Time frame: Baseline

    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.

  2. PedsQL Cognitive Function

    Time frame: Baseline

    Measures cognitive functioning in patients with acute and chronic health conditions as well as healthy school and community populations.

  3. Health Behavior Inventory (HBI)

    Time frame: Baseline, at intervention completion an average of 4 weeks, and for a 3 month follow up after completed intervention.

    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.

Sponsors and collaborators

Lead sponsor

University of Oregon

Other

Collaborators

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

Registry information

Official study title

Brain Injury Support and Strategies for Families Impacted by Childhood TBI

Acronym: TIPS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 8, 2019
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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