Internet-Based Treatment for Children With Traumatic Brain Injuries & Their Families: Counselor Assisted Problem Solving

Not Applicable

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Behavioral: Internet-resource comparison (IRC); Behavioral: Counselor-assisted problem solving (CAPS)

• Registration Number: NCT00409448
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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 children who have had a traumatic brain injury and their families.

Detailed Description

A traumatic brain injury (TBI) is caused by a strong blow, jolt, or penetration to the head that disrupts normal brain functioning. A TBI can range from a mild concussion to severe brain damage. Falls, assaults, and motor vehicle accidents account for more than 50% of TBIs. Physical symptoms of a TBI can be subtle to severe and can include nausea, memory loss, mood swings, blurred vision, and light-headedness. This type of injury can be very stressful for families and can result in feelings of anxiety, burden, and depression among family members. A child who experiences a TBI will often display new social and behavioral problems, leading to further parental distress and increased family dysfunction. Recent studies have shown that problem-solving interventions can reduce caregiver distress and improve child adjustment following a TBI. However, access to skilled therapists and specialized care for this kind of psychosocial treatment is often limited in many communities. In such communities, the Internet offers a new way to meet the mental and other health needs of individuals with TBIs. 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 TBI and their families.

Families participating in this study will be randomly assigned to either an Internet-based counselor-assisted problem-solving (CAPS) group or an Internet resource comparison group (IRC). Participants assigned to CAPS will work with a trained counselor who will guide them through a 6-month structured online problem-solving and skill-building program via one-on-one videoconference sessions. Families assigned to IRC will receive computers, high speed Internet access, and links to brain injury information and resources, but no access to the CAPS Web site content. The effectiveness of CAPS will be assessed after treatment and at 6- and 12-month follow-up evaluations.

Study Timeline

• Study First Submitted: 2006-12-07
• Study First Submitted QC: 2006-12-07
• Study First Posted: 2006-12-08
• Study Start: 2007-03
• Primary Completion: 2012-07
• Study Completion: 2012-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-18
• Last Update Posted: 2014-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Moderate to severe TBI that occurred within the last 6 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 nonblunt 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IRC	Internet-resource comparison (IRC)	Participants will receive the Internet resource comparison group treatment
CAPS	Counselor-assisted problem solving (CAPS)	Participants will receive the Internet-based counselor-assisted problem-solving group treatment

Primary Outcome Measures

Name	Time	Method
Parent report measures	5 years
Teen self-report measures	5 years

Secondary Outcome Measures

Name	Time	Method
Neuropsychological testing	5 years

Trial Locations

Locations (5)

The Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States

Denver Children's Hospital; 🇺🇸 Denver, Colorado, United States

Rainbow Babies and Children's Hospital; 🇺🇸 Cleveland, Ohio, United States

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States