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

This study has been completed.
Sponsor:
Collaborator:
Nationwide Children's Hospital
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00409058
First received: December 7, 2006
Last updated: October 27, 2014
Last verified: September 2014

December 7, 2006
October 27, 2014
October 2005
November 2009   (final data collection date for primary outcome measure)
Parent Report Measures [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00409058 on ClinicalTrials.gov Archive Site
Teen Self-Report Measures [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Teen Online Problem Solving (TOPS) - An Online Intervention Following TBI
An Online Intervention for Families Following Adolescent TBI - Teen Online Problem Solving (TOPS)

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • TBI (Traumatic Brain Injury)
  • Brain Edema
  • Craniocerebral Trauma
  • Hematoma
  • Brain Concussion
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: 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.
    Intervention: Behavioral: Teen Online Problem Solving
  • 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.
    Intervention: Behavioral: Teen Online Problem Solving
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
December 2009
November 2009   (final data collection date for primary outcome measure)

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.
Both
11 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00409058
05-10-36, H133G050239
No
Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
Nationwide Children's Hospital
Principal Investigator: Shari L Wade, PhD Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP