Clinical trial NCT00409058: Teen Online Problem Solving (TOPS) - An Online Intervention Following TBI
Official title: An Online Intervention for Families Following Adolescent TBI - Teen Online Problem Solving (TOPS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TBI (Traumatic Brain Injury)
Brain Edema
Craniocerebral Trauma
Hematoma
Brain Concussion
Keywords: TBI (Traumatic Brain Injury)
Intracranial Edema
Brain Edema
Craniocerebral Trauma
Head Injury
Brain Hemorrhage, Traumatic
Subdural Hematoma
Brain Concussion
Head Injuries, Closed
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Nationwide Children's Hospital
First posted: 2006-12-08
Enrollment: 42
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Parent Report Measures
timeFrame: 4 years
Secondary outcomes:
measure: Teen Self-Report Measures
timeFrame: 4 years
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Shari L Wade, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wade SL, Fisher AP, Kaizar EE, Yeates KO, Taylor HG, Zhang N. Recovery Trajectories of Child and Family Outcomes Following Online Family Problem-Solving Therapy for Children and Adolescents after Traumatic Brain Injury. J Int Neuropsychol Soc. 2019 Oct;25(9):941-949. doi: 10.1017/S1355617719000778. Epub 2019 Aug 13.
citation: Wade SL, Kaizar EE, Narad M, Zang H, Kurowski BG, Yeates KO, Taylor HG, Zhang N. Online Family Problem-solving Treatment for Pediatric Traumatic Brain Injury. Pediatrics. 2018 Dec;142(6):e20180422. doi: 10.1542/peds.2018-0422. Epub 2018 Nov 9.
citation: Wade SL, Walz NC, Carey J, McMullen KM, Cass J, Mark E, Yeates KO. A randomized trial of teen online problem solving: efficacy in improving caregiver outcomes after brain injury. Health Psychol. 2012 Nov;31(6):767-76. doi: 10.1037/a0028440. Epub 2012 Jul 2.