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

Brain Concussion Clinical Trial

— TOPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409058
• Other study ID #: 05-10-36
• Secondary ID: H133G050239
• Status: Completed
• Phase: N/A
• First received: December 7, 2006
• Last updated: October 27, 2014
• Start date: October 2005
• Est. completion date: December 2009

Study information

• Verified date: September 2014
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Concussion
• Brain Edema
• Brain Injuries
• Craniocerebral Trauma
• Hematoma
• TBI (Traumatic Brain Injury)

Intervention

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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parent Report Measures		4 years	No
Secondary	Teen Self-Report Measures		4 years	No