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

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counselor-assisted problem solving (CAPS)
Internet-resource comparison (IRC)
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring 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

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Denver Children's Hospital
  • The Mayo Clinic
  • Cincinnati Children's Hospital
  • MetroHealth Medical Center
  • Rainbow Babies and Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CAPS

IRC

Arm Description

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

Participants will receive the Internet resource comparison group treatment

Outcomes

Primary Outcome Measures

Parent report measures
Teen self-report measures

Secondary Outcome Measures

Neuropsychological testing

Full Information

First Posted
December 7, 2006
Last Updated
September 18, 2014
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT00409448
Brief Title
Internet-Based Treatment for Children With Traumatic Brain Injuries & Their Families: Counselor Assisted Problem Solving
Acronym
CAPS
Official Title
Improving Mental Health Outcomes of Child Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAPS
Arm Type
Experimental
Arm Description
Participants will receive the Internet-based counselor-assisted problem-solving group treatment
Arm Title
IRC
Arm Type
Active Comparator
Arm Description
Participants will receive the Internet resource comparison group treatment
Intervention Type
Behavioral
Intervention Name(s)
Counselor-assisted problem solving (CAPS)
Intervention Description
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
Intervention Name(s)
Internet-resource comparison (IRC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Parent report measures
Time Frame
5 years
Title
Teen self-report measures
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Neuropsychological testing
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shari L. Wade, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Children's Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
The Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35170571
Citation
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.
Results Reference
derived
PubMed Identifier
30413559
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.
Results Reference
derived
PubMed Identifier
29097272
Citation
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.
Results Reference
derived
PubMed Identifier
26461100
Citation
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.
Results Reference
derived
PubMed Identifier
25738891
Citation
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.
Results Reference
derived
PubMed Identifier
25583911
Citation
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.
Results Reference
derived
PubMed Identifier
24781374
Citation
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.
Results Reference
derived
PubMed Identifier
23790158
Citation
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.
Results Reference
derived
PubMed Identifier
23753094
Citation
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. Erratum In: Pediatrics. 2015 Oct;136(4):782-3.
Results Reference
derived
PubMed Identifier
23640543
Citation
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.
Results Reference
derived

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

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