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

Traumatic Brain Injury research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Traumatic Brain Injury

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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.

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.

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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Teen Online Problem Solving (TOPS)Web intervention

Teen Online Problem Solving---Teen OnlyWeb Intervention

Internet Resources ComparisonWeb Intervention

Study Status

Completed

Start Date: March 2010

Completed Date: December 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Parent Report Measures

Secondary Outcome: Teen Self-Report Measures

Study sponsors, principal investigator, and references

Principal Investigator: Sharil L Wade, PhD

Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Collaborator: MetroHealth Medical Center

More information:https://clinicaltrials.gov/show/NCT01042899

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