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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Traumatic Brain Injury	Behavioral: Teen Online Problem Solving (TOPS); Behavioral: Teen Online Problem Solving--Teen Only (TOPS-TO); Behavioral: Internet Resources Comparison (IRC)	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	153 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions
Study Start Date :	March 2010
Actual Primary Completion Date :	December 2015
Actual Study Completion Date :	December 2015

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Teen Online Problem Solving (TOPS); Web intervention	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 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 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
Experimental: Teen Online Problem Solving---Teen Only; Web Intervention	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; Web Intervention	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

Outcome Measures

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Primary Outcome Measures :

1. Parent Report Measures [ Time Frame: 5 years ]

Secondary Outcome Measures :

1. Teen Self-Report Measures [ Time Frame: 5 years ]
2. Neuropsychological Testing [ Time Frame: 5 years ]

Eligibility Criteria

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Ages Eligible for Study:	11 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
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

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Locations

United States, Colorado
The Children's Hospital
Denver, Colorado, United States, 80045
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45224
Rainbow Babies' and Children's Hospital
Cleveland, Ohio, United States, 44106
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati

MetroHealth Medical Center

Nationwide Children's Hospital

Rainbow Babies and Children's Hospital

Children's Hospital Colorado

Investigators

Principal Investigator:	Sharil L Wade, PhD	Children's Hospital Medical Center, Cincinnati

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wade SL, Narad ME, Kingery KM, Taylor HG, Stancin T, Kirkwood MW, Yeates KO. Teen online problem solving for teens with traumatic brain injury: Rationale, methods, and preliminary feasibility of a teen only intervention. Rehabil Psychol. 2017 Aug;62(3):290-299. doi: 10.1037/rep0000160.

Wade SL, Cassedy AE, Fulks LE, Taylor HG, Stancin T, Kirkwood MW, Yeates KO, Kurowski BG. Problem-Solving After Traumatic Brain Injury in Adolescence: Associations With Functional Outcomes. Arch Phys Med Rehabil. 2017 Aug;98(8):1614-1621. doi: 10.1016/j.apmr.2017.03.006. Epub 2017 Apr 4.

Responsible Party:	Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:	NCT01042899 History of Changes
Other Study ID Numbers:	H133B090010--01
First Posted:	January 6, 2010
Last Update Posted:	March 8, 2016
Last Verified:	March 2016

Keywords provided by Children's Hospital Medical Center, Cincinnati:

TBI; intracranial edema; brain edema; craniocerebral trauma; head injury; brain hemorrhage, traumatic; subdural hematoma; brain concussion	head injuries, closed; epidural hematoma; extra-axial hemorrhage; cortical contusion; wounds and injuries; disorders of environmental origin; trauma, nervous system; brain injuries

Additional relevant MeSH terms:

Wounds and Injuries; Brain Injuries; Brain Injuries, Traumatic; Brain Diseases	Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System