Teen Online Problem Solving (TOPS) - An Online Intervention Following TBI

Study Overview
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Brief Summary
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The purpose of this study is to learn if using the World Wide Web to train teens and their families in problem-solving, communication skills, and stress management strategies can help them to cope better following traumatic brain injury (TBI). To answer this question, we will look at changes from before the intervention to after the intervention on questionnaire measures of problem-solving skills, communication, social competence, adjustment, and family stress and burden. We hypothesize that families receiving the TOPS intervention will have better parent-child communication and problem-solving skills at follow-up than those receiving the IRC intervention. Additionally, families receiving the TOPS intervention will have lower levels of parental distress, fewer child behavior problems and better child functioning than those receiving the IRC intervention. Lastly, treatment effects will be moderated by SES and life stresses, such that families with greater social disadvantage will benefit more from the TOPS intervention.

Detailed Description
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Traumatic Brain Injury (TBI) creates significant stress for families resulting in increased burden, anxiety and depression among family members. Both pre- and post-injury family functioning have been linked to child outcomes, suggesting that improvements in family adaptation may result in fewer social and behavioral sequelae in the injured child. Despite this evidence, the development and evaluation of family interventions following TBI are extremely rare. Children with TBI are often treated at urban trauma centers then discharged to distant home communities where psychosocial follow-up is limited and/or difficult to access. Increasingly, the World Wide Web is being used to meet the mental and other health needs of individuals who have difficulty accessing care through traditional routes. Given the lack of specialized care and follow-up for TBI in many communities, the Web may provide an invaluable tool for linking families with state-of-the-art psychosocial care by reducing potential physical and psychological barriers (e.g., distance, stigma). Building on previous intervention research of the PI, this study targets the adolescent population between the ages of 12-18. By identifying the unique concerns and issues of this population following brain injury, Teen Online Problem Solving seeks to improve family and teen adaptation, thereby reducing social and behavioral sequelae. Comparison(s): Teen Online Problem Solving (TOPS) intervention with online curriculum and sequential videoconference therapy sessions in addition to usual care, compared to Internet Resource Comparison with online access to resources in addition to usual care.

Official Title
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An Online Intervention for Families Following Adolescent TBI - Teen Online Problem Solving (TOPS)

Conditions
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TBI (Traumatic Brain Injury), Brain Edema, Craniocerebral Trauma, Hematoma, Brain Concussion

Intervention / Treatment
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* Behavioral: Teen Online Problem Solving


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between 11 and 18 years of age moderate to severe traumatic brain injury overnight hospital stay injury occurred within the last 12 months Exclusion Criteria: younger than 11 and older than 18 years of age injury occurred more than 12 months ago teen does not live with parents or guardian English not spoken in the home injury is a result of child abuse as documented by medical record child or parent has history of hospitalization for a psychiatric problem documentation that the injury is a result of child abuse child suffered a non-blunt injury (e.g. projectile wounds, stroke, drowning, or other form of asphyxiation) child ever diagnosed with moderate or severe mental retardation, Autism, or a significant developmental disability (child must be able to talk) plans for the child to leave home during the coming 12 months.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teen Online Problem Solving<br>The TOPS program has 10 sessions that provide training in stress management, problem solving, communication, and social skills to all enrolled families, while the remaining 6 sessions address content related to the stressors and burdens of individual families. Each self-guided online session includes real adolescents talking about how TBI affected them, content regarding the skill, video clips showing adolescents and/or families modeling the skill, and exercises giving the family an opportunity to practice the skill. After the completion of the self-guided web pages, the family will meet with the therapist via videoconference; the therapist will review the exercises and help the family implement the problem-solving process with a problem or goal identified by the family. | Behavioral: Teen Online Problem Solving<br>* We will test the following hypotheses: 1) Children with TBI receiving TOPS will have fewer behavior problems, greater social competence, and better functioning than those receiving IRC at both post-treatment and at a 6-month follow-up assessment. 2) Caregivers of children receiving TOPS will report less depression and psychological distress, less parent-child conflict, and better family functioning than those receiving IRC at both post-treatment and at a 6-month follow-up assessment. 3) Social resources will moderate treatment efficacy, such that children with limited social and economic resources will show greater improvements in the more comprehensive TOPS intervention. We hypothesize better teen problem solving and communication skills, fewer teen emotional/behavioral problems, less parental burden and distress, and less parent-teen conflict at follow-up among the TOPS group compared to the IRC group.<br>* Other names: IRC;|
| Experimental: Internet Resources Comparison<br>Families in the IRC group will also receive a computer, printer, and high-speed internet access if they do not currently have these. Additionally, IRC families receive access to a home page of brain injury resources and links (identical to those given on the TOPS and TOPS-TO homepage) but will not be able to access specific session content. This will enable us to equate the groups with respect to access to the information and resources available on the Web. | Behavioral: Teen Online Problem Solving<br>* We will test the following hypotheses: 1) Children with TBI receiving TOPS will have fewer behavior problems, greater social competence, and better functioning than those receiving IRC at both post-treatment and at a 6-month follow-up assessment. 2) Caregivers of children receiving TOPS will report less depression and psychological distress, less parent-child conflict, and better family functioning than those receiving IRC at both post-treatment and at a 6-month follow-up assessment. 3) Social resources will moderate treatment efficacy, such that children with limited social and economic resources will show greater improvements in the more comprehensive TOPS intervention. We hypothesize better teen problem solving and communication skills, fewer teen emotional/behavioral problems, less parental burden and distress, and less parent-teen conflict at follow-up among the TOPS group compared to the IRC group.<br>* Other names: IRC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent Report Measures |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Teen Self-Report Measures |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain Edema, TBI (Traumatic Brain Injury), Intracranial Edema, Craniocerebral Trauma, Head Injury, Brain Hemorrhage, Traumatic, Subdural Hematoma, Brain Concussion, Head Injuries, Closed