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

NCT00409448 | Completed DMC

• 2 other identifiers: R01MH073764DDTR B2-NDA
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 5

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.

Conditions

Traumatic Brain Injury

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Parent report measures

  5 years

• Teen self-report measures

  5 years

Secondary Outcomes (1)

• Neuropsychological testing

  5 years

Study Arms (2)

CAPS

EXPERIMENTAL

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

Behavioral: Counselor-assisted problem solving (CAPS)

IRC

ACTIVE COMPARATOR

Participants will receive the Internet resource comparison group treatment

Behavioral: Internet-resource comparison (IRC)

Interventions

Counselor-assisted problem solving (CAPS) 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.

CAPS

Internet-resource comparison (IRC) 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.

IRC

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Moderate to severe TBI that occurred within the last 6 months
• Overnight hospital stay
• English-speaking
• Parent must be willing to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (5)

Denver Children's Hospital

Denver, Colorado, 80045, United States

Location

The Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44106, United States

Location

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Related Publications (10)

• 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.

  PMID: 35170571 DERIVED

• 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.

  PMID: 30413559 DERIVED

• 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.

  PMID: 29097272 DERIVED

• 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.

  PMID: 26461100 DERIVED

• 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.

  PMID: 25738891 DERIVED

• 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.

  PMID: 25583911 DERIVED

• 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.

  PMID: 24781374 DERIVED

• 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.

  PMID: 23790158 DERIVED

• 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.

  PMID: 23753094 DERIVED

• 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.

  PMID: 23640543 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Edema; Craniocerebral Trauma; Brain Hemorrhage, Traumatic; Hematoma, Subdural; Brain Concussion; Head Injuries, Closed; Hematoma, Epidural, Spinal; Brain Contusion

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hematoma; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds, Nonpenetrating; Contusions

Study Officials

• Shari L. Wade, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2006
• First Posted: December 8, 2006
• Study Start: March 1, 2007
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 19, 2014

Record last verified: 2014-09

Locations

US (5)