We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00409058
First Posted: December 8, 2006
Last Update Posted: October 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Nationwide Children's Hospital
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
  Purpose
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.

Condition Intervention
TBI (Traumatic Brain Injury) Brain Edema Craniocerebral Trauma Hematoma Brain Concussion Behavioral: Teen Online Problem Solving

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Online Intervention for Families Following Adolescent TBI - Teen Online Problem Solving (TOPS)

Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Parent Report Measures [ Time Frame: 4 years ]

Secondary Outcome Measures:
  • Teen Self-Report Measures [ Time Frame: 4 years ]

Enrollment: 42
Study Start Date: October 2005
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Teen Online Problem Solving
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
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.
Other Names:
  • TOPS
  • IRC
Experimental: Internet Resources Comparison
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
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.
Other Names:
  • TOPS
  • IRC

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409058


Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Nationwide Children's Hospital
Investigators
Principal Investigator: Shari L Wade, PhD Children's Hospital Medical Center, Cincinnati
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00409058     History of Changes
Other Study ID Numbers: 05-10-36
H133G050239 ( Other Grant/Funding Number: NIDRR )
First Submitted: December 7, 2006
First Posted: December 8, 2006
Last Update Posted: October 28, 2014
Last Verified: September 2014

Keywords provided by Children's Hospital Medical Center, Cincinnati:
TBI (Traumatic Brain Injury)
Intracranial Edema
Brain Edema
Craniocerebral Trauma
Head Injury
Brain Hemorrhage, Traumatic
Subdural Hematoma
Brain Concussion
Head Injuries, Closed

Additional relevant MeSH terms:
Brain Concussion
Brain Injuries
Hematoma
Brain Edema
Craniocerebral Trauma
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Hemorrhage
Pathologic Processes
Head Injuries, Closed
Wounds, Nonpenetrating