Traumatic Brain Injury Positive Strategies

Study Overview
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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).

Official Title
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Brain Injury Support and Strategies for Families Impacted by Childhood TBI

Conditions
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Brain Injuries, Traumatic

Intervention / Treatment
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* Behavioral: TIPS Intervention
* Behavioral: Control


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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. |