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

Cincinnati Children's Hospital Medical Center logo

Cincinnati Children's Hospital Medical Center

Status

Completed

Conditions

Traumatic Brain Injury

Treatments

Behavioral: Teen Online Problem Solving--Teen Only (TOPS-TO)
Behavioral: Internet Resources Comparison (IRC)
Behavioral: Teen Online Problem Solving (TOPS)

Study type

Interventional

Funder types

Other

Identifiers

NCT01042899
H133B090010--01

Details and patient eligibility

About

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.

Full 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.

Enrollment

153 patients

Sex

All

Ages

11 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

153 participants in 3 patient groups

Teen Online Problem Solving (TOPS)
Experimental group
Description:
Web intervention
Treatment:
Behavioral: Teen Online Problem Solving (TOPS)
Behavioral: Internet Resources Comparison (IRC)
Behavioral: Teen Online Problem Solving--Teen Only (TOPS-TO)
Teen Online Problem Solving---Teen Only
Experimental group
Description:
Web Intervention
Treatment:
Behavioral: Teen Online Problem Solving--Teen Only (TOPS-TO)
Internet Resources Comparison
Active Comparator group
Description:
Web Intervention
Treatment:
Behavioral: Internet Resources Comparison (IRC)

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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