Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions

Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Teen Online Problem Solving Study

Sponsors

Lead sponsor: Children's Hospital Medical Center, Cincinnati

Collaborator: MetroHealth Medical Center
Nationwide Children's Hospital
Rainbow Babies and Children's Hospital
Children's Hospital Colorado

Source Children's Hospital Medical Center, Cincinnati
Brief Summary

This study will evaluate the effectiveness of an Internet-based psychosocial treatment in improving problem-solving, communication skills, stress management strategies, and coping among teens who have had a traumatic brain injury and their families.

Detailed Description

Traumatic brain injury (TBI) in adolescents is a significant stressor for both the teen and his or her family. Existing interventions are rare and access to treatment can be restricted by distance and finances. Based on previous findings and participant feedback, we propose to expand the previously developed TOPS intervention by conducting a multi-site study comparing the efficacy of TOPS to that of TOPS-Teen Only (TOPS-TO) in improving child behavior and functioning, parental depression and distress and family functioning. The efficacy of both active treatments would be examined in relation to an internet resource comparison group (IRC). During years 1-3, we will recruit 165 children between the ages of 11 and 18 with moderate to severe TBI and randomly assign them to receive TOPS, TOPS-TO, or IRC. We anticipate that TOPS will result in improvements in child, caregiver, and family functioning relative to IRC; but that TOPS-TO will only result in improvements in child behavior and adjustment. Based on prior research, we anticipate that the family-level treatment model of TOPS may be more effective than TOPS-TO in improving child behavior for children/adolescents with fewer social resources. Given these expectations, we will test the following hypotheses: 1) Children with TBI receiving either TOPS or TOPS-TO 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 TOPS-TO or 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. TOPS makes use of emerging technology to address the multifaceted needs of teens following TBI with the goal of improving the teen's social and emotional functioning, thereby enabling him or her to better negotiate the complex transition to adulthood and independent functioning.

Overall Status Completed
Start Date March 2010
Completion Date December 2015
Primary Completion Date December 2015
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Parent Report Measures 5 years
Secondary Outcome
Measure Time Frame
Teen Self-Report Measures 5 years
Neuropsychological Testing 5 years
Enrollment 153
Condition
Intervention

Intervention type: Behavioral

Intervention name: Teen Online Problem Solving (TOPS)

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 group label: Teen Online Problem Solving (TOPS)

Other name: TOPS

Intervention type: Behavioral

Intervention name: Teen Online Problem Solving--Teen Only (TOPS-TO)

Description: TOPS-TO targets the same skills as TOPS and includes largely the same website and intervention content. However, it differs with respect to the extent of family involvement in the sessions. In TOPS-TO, sessions will be conducted with the child or adolescent alone, rather than with the family as whole. Parents will be given access to the TOPS-TO website content via their own password protected site so they will understand the skills that their child is learning. However, only the adolescent, and not the parents, will participate in the synchronous videoconferences with the therapist.

Other name: TOPS-TO

Intervention type: Behavioral

Intervention name: Internet Resources Comparison (IRC)

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.

Other name: IRC

Eligibility

Criteria:

Inclusion Criteria:

- Moderate to severe TBI that occurred within the last 18 months

- Overnight hospital stay

- English-speaking

- Parent must be willing to provide informed consent

Exclusion Criteria:

- Child does not live with parents or guardian

- Child or parent has history of hospitalization for psychiatric problem

- TBI is a result of child abuse

- Child suffered a non-blunt injury (e.g., projectile wound, stroke, drowning, or other form of asphyxiation)

- Diagnosed with moderate or severe mental retardation, autism, or a significant developmental disability

Gender: All

Minimum age: 11 Years

Maximum age: 18 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Sharil L Wade, PhD Principal Investigator Children's Hospital Medical Center, Cincinnati
Location
facility
The Children's Hospital | Denver, Colorado, 80045, United States
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio, 45224, United States
Rainbow Babies' and Children's Hospital | Cleveland, Ohio, 44106, United States
MetroHealth Medical Center | Cleveland, Ohio, 44109, United States
Nationwide Children's Hospital | Columbus, Ohio, 43205, United States
Location Countries

United States

Verification Date

March 2016

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Teen Online Problem Solving (TOPS)

Arm group type: Experimental

Description: Web intervention

Arm group label: Teen Online Problem Solving---Teen Only

Arm group type: Experimental

Description: Web Intervention

Arm group label: Internet Resources Comparison

Arm group type: Active Comparator

Description: Web Intervention

Acronym RRTC--TOPS
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov