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Traumatic Brain Injury Positive Strategies

Brain Injury Support and Strategies for Families Impacted by Childhood TBI

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03867968
Acronym
TIPS
Enrollment
132
Registered
2019-03-08
Start date
2019-02-13
Completion date
2020-03-06
Last updated
2020-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries, Traumatic

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.

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).

Interventions

Web-based training for family member.

BEHAVIORALControl

Traumatic Brain Injury website for family members.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Caregiver Self-Efficacy ScaleBaseline, 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.
TIPS Change in Knowledge SurveyBaseline , 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.
PedsQL Family ImpactBaseline 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.

Secondary

MeasureTime frameDescription
The Pediatric Quality of Life Inventory (PedsQL)Baseline23 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.
PedsQL Cognitive FunctionBaselineMeasures cognitive functioning in patients with acute and chronic health conditions as well as healthy school and community populations.
Health Behavior Inventory (HBI)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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026