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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Collaborators:
MetroHealth Medical Center
Nationwide Children's Hospital
Rainbow Babies & Children's Hospital
Children's Hospital Colorado
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01042899
First received: January 5, 2010
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Traumatic Brain Injury
Behavioral: Teen Online Problem Solving (TOPS)
Behavioral: Teen Online Problem Solving--Teen Only (TOPS-TO)
Behavioral: Internet Resources Comparison (IRC)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Parent Report Measures [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Teen Self-Report Measures [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Neuropsychological Testing [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 165
Study Start Date: March 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Teen Online Problem Solving Behavioral: Teen Online Problem Solving (TOPS)
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.
Other Name: TOPS
Experimental: Teen Online Problem Solving---Teen Only Behavioral: Teen Online Problem Solving--Teen Only (TOPS-TO)
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
Active Comparator: Internet Resources Comparison Behavioral: Internet Resources Comparison (IRC)
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

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.

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042899

Contacts
Contact: Kendra M McMullen, MA 513-636-1055 kendra.mcmullen@cchmc.org

Locations
United States, Colorado
The Children's Hospital Recruiting
Denver, Colorado, United States, 80045
Contact: Robert Z Blaha, MA    720-777-5896    robert.blaha@childrenscolorado.org   
Principal Investigator: Michael Kirkwood, PhD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45224
Contact: Kendra M McMullen, MA    513-636-1055    kendra.mcmullen@cchmc.org   
Principal Investigator: Shari L Wade, PhD         
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Mary Ann Toth    216-778-4917    matoth@metrohealth.org   
Contact: Britt Nielsen, PsyD    216-778-3734    bnielsen@metrohealth.org   
Principal Investigator: Terry Stancin, PhD         
Rainbow Babies' and Children's Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Elizabeth Roth, PhD    216-368-5783    elizabeth.roth@case.edu   
Principal Investigator: H. Gerry Taylor, PhD         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: April Utt, MA    614-355-3471    April.Utt@nationwidechildrens.org   
Principal Investigator: Keith O Yeates, PhD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
MetroHealth Medical Center
Nationwide Children's Hospital
Rainbow Babies & Children's Hospital
Children's Hospital Colorado
Investigators
Principal Investigator: Sharil L Wade, PhD Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01042899     History of Changes
Other Study ID Numbers: H133B090010--01
Study First Received: January 5, 2010
Last Updated: October 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
cortical contusion
TBI
intracranial edema
brain edema
craniocerebral trauma
head injury
brain hemorrhage, traumatic
subdural hematoma
brain concussion
head injuries, closed
epidural hematoma
extra-axial hemorrhage
wounds and injuries
disorders of environmental origin
trauma, nervous system
brain injuries

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014