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

NCT ID: NCT00409448

Last Updated: 2014-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2012-08-31

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CAPS

Participants will receive the Internet-based counselor-assisted problem-solving group treatment

Group Type: EXPERIMENTAL

Counselor-assisted problem solving (CAPS)

Intervention Type: BEHAVIORAL

In CAPS, a trained counselor will guide families through a 6-month structured online problem-solving and skill-building program via one-on-one videoconference sessions.

IRC

Participants will receive the Internet resource comparison group treatment

Group Type: ACTIVE_COMPARATOR

Internet-resource comparison (IRC)

Intervention Type: BEHAVIORAL

Families in the IRC group will receive computers, high speed internet access, and links to brain injury information and resources, but not the CAPS website content.

Interventions

Counselor-assisted problem solving (CAPS)

In CAPS, a trained counselor will guide families through a 6-month structured online problem-solving and skill-building program via one-on-one videoconference sessions.

Intervention Type: BEHAVIORAL

Internet-resource comparison (IRC)

Families in the IRC group will receive computers, high speed internet access, and links to brain injury information and resources, but not the CAPS website content.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shari L. Wade, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Denver Children's Hospital

Denver, Colorado, United States

The Mayo Clinic

Rochester, Minnesota, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Countries

United States

References

Narad ME, Kaizar EE, Zhang N, Taylor HG, Yeates KO, Kurowski BG, Wade SL. The Impact of Preinjury and Secondary Attention-Deficit/Hyperactivity Disorder on Outcomes After Pediatric Traumatic Brain Injury. J Dev Behav Pediatr. 2022 Aug 1;43(6):e361-e369. doi: 10.1097/DBP.0000000000001067. Epub 2022 Feb 15.

Reference Type: DERIVED

PMID: 35170571 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30413559 (View on PubMed)

Huebner ARS, Cassedy A, Brown TM, Taylor HG, Stancin T, Kirkwood MW, Wade SL. Use of Mental Health Services by Adolescents After Traumatic Brain Injury: A Secondary Analysis of a Randomized Controlled Trial. PM R. 2018 May;10(5):462-471. doi: 10.1016/j.pmrj.2017.10.004. Epub 2017 Oct 31.

Reference Type: DERIVED

PMID: 29097272 (View on PubMed)

Narad ME, Minich N, Taylor HG, Kirkwood MW, Brown TM, Stancin T, Wade SL. Effects of a Web-Based Intervention on Family Functioning Following Pediatric Traumatic Brain Injury. J Dev Behav Pediatr. 2015 Nov-Dec;36(9):700-7. doi: 10.1097/DBP.0000000000000208.

Reference Type: DERIVED

PMID: 26461100 (View on PubMed)

Wade SL, Taylor HG, Cassedy A, Zhang N, Kirkwood MW, Brown TM, Stancin T. Long-Term Behavioral Outcomes after a Randomized, Clinical Trial of Counselor-Assisted Problem Solving for Adolescents with Complicated Mild-to-Severe Traumatic Brain Injury. J Neurotrauma. 2015 Jul 1;32(13):967-75. doi: 10.1089/neu.2014.3684. Epub 2015 May 7.

Reference Type: DERIVED

PMID: 25738891 (View on PubMed)

Wade SL, Kurowski BG, Kirkwood MW, Zhang N, Cassedy A, Brown TM, Nielsen B, Stancin T, Taylor HG. Online problem-solving therapy after traumatic brain injury: a randomized controlled trial. Pediatrics. 2015 Feb;135(2):e487-95. doi: 10.1542/peds.2014-1386. Epub 2015 Jan 12.

Reference Type: DERIVED

PMID: 25583911 (View on PubMed)

Kurowski BG, Wade SL, Kirkwood MW, Brown TM, Stancin T, Taylor HG. Long-term benefits of an early online problem-solving intervention for executive dysfunction after traumatic brain injury in children: a randomized clinical trial. JAMA Pediatr. 2014 Jun;168(6):523-31. doi: 10.1001/jamapediatrics.2013.5070.

Reference Type: DERIVED

PMID: 24781374 (View on PubMed)

Arnett AB, Peterson RL, Kirkwood MW, Taylor HG, Stancin T, Brown TM, Wade SL. Behavioral and cognitive predictors of educational outcomes in pediatric traumatic brain injury. J Int Neuropsychol Soc. 2013 Sep;19(8):881-9. doi: 10.1017/S1355617713000635. Epub 2013 Jun 21.

Reference Type: DERIVED

PMID: 23790158 (View on PubMed)

Kurowski BG, Wade SL, Kirkwood MW, Brown TM, Stancin T, Taylor HG. Online problem-solving therapy for executive dysfunction after child traumatic brain injury. Pediatrics. 2013 Jul;132(1):e158-66. doi: 10.1542/peds.2012-4040. Epub 2013 Jun 10.

Reference Type: DERIVED

PMID: 23753094 (View on PubMed)

Wade SL, Stancin T, Kirkwood M, Brown TM, McMullen KM, Taylor HG. Counselor-assisted problem solving (CAPS) improves behavioral outcomes in older adolescents with complicated mild to severe TBI. J Head Trauma Rehabil. 2014 May-Jun;29(3):198-207. doi: 10.1097/HTR.0b013e31828f9fe8.

Reference Type: DERIVED

PMID: 23640543 (View on PubMed)

Other Identifiers

DDTR B2-NDA

Identifier Type: -

Identifier Source: secondary_id

R01MH073764

Identifier Type: NIH

Identifier Source: org_study_id

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