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

Primary Purpose

TBI (Traumatic Brain Injury), Brain Edema, Craniocerebral Trauma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Teen Online Problem Solving
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for TBI (Traumatic Brain Injury) focused on measuring TBI (Traumatic Brain Injury), Intracranial Edema, Brain Edema, Craniocerebral Trauma, Head Injury, Brain Hemorrhage, Traumatic, Subdural Hematoma, Brain Concussion, Head Injuries, Closed

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cincinnati Children's Hospital Medical Center
  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Teen Online Problem Solving

Internet Resources Comparison

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Parent Report Measures

Secondary Outcome Measures

Teen Self-Report Measures

Full Information

First Posted
December 7, 2006
Last Updated
October 27, 2014
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Nationwide Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00409058
Brief Title
Teen Online Problem Solving (TOPS) - An Online Intervention Following TBI
Acronym
TOPS
Official Title
An Online Intervention for Families Following Adolescent TBI - Teen Online Problem Solving (TOPS)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Nationwide Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TBI (Traumatic Brain Injury), Brain Edema, Craniocerebral Trauma, Hematoma, Brain Concussion
Keywords
TBI (Traumatic Brain Injury), Intracranial Edema, Brain Edema, Craniocerebral Trauma, Head Injury, Brain Hemorrhage, Traumatic, Subdural Hematoma, Brain Concussion, Head Injuries, Closed

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Teen Online Problem Solving
Arm Type
Experimental
Arm Description
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.
Arm Title
Internet Resources Comparison
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Teen Online Problem Solving
Other Intervention Name(s)
TOPS, IRC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Parent Report Measures
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Teen Self-Report Measures
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shari L Wade, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31405391
Citation
Wade SL, Fisher AP, Kaizar EE, Yeates KO, Taylor HG, Zhang N. Recovery Trajectories of Child and Family Outcomes Following Online Family Problem-Solving Therapy for Children and Adolescents after Traumatic Brain Injury. J Int Neuropsychol Soc. 2019 Oct;25(9):941-949. doi: 10.1017/S1355617719000778. Epub 2019 Aug 13.
Results Reference
derived
PubMed Identifier
30413559
Citation
Wade SL, Kaizar EE, Narad M, Zang H, Kurowski BG, Yeates KO, Taylor HG, Zhang N. Online Family Problem-solving Treatment for Pediatric Traumatic Brain Injury. Pediatrics. 2018 Dec;142(6):e20180422. doi: 10.1542/peds.2018-0422. Epub 2018 Nov 9.
Results Reference
derived
PubMed Identifier
22746261
Citation
Wade SL, Walz NC, Carey J, McMullen KM, Cass J, Mark E, Yeates KO. A randomized trial of teen online problem solving: efficacy in improving caregiver outcomes after brain injury. Health Psychol. 2012 Nov;31(6):767-76. doi: 10.1037/a0028440. Epub 2012 Jul 2.
Results Reference
derived

Learn more about this trial

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

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