NCT01056146

Brief Summary

The purpose of this study is to test an on-line intervention for families of young children who have experienced moderate or severe traumatic brain injury (TBI). Previous interventions were not designed to address the needs of young children with TBI, and feedback revealed a desire for more examples and materials appropriate for families of younger children. This project builds upon the investigators previous research by modifying the online intervention content to address the needs of young children with TBI. The goal of this project is to develop an intervention that will encourage positive parenting behaviors, improve child behaviors, and reduce parent distress and burden following TBI. The investigators hypothesize that the intervention group will exhibit more effective parenting skills as well as better child functioning and lower levels of parental distress at follow-up than will the active comparison group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 28, 2014

Status Verified

September 1, 2014

Enrollment Period

3.5 years

First QC Date

January 20, 2010

Last Update Submit

October 27, 2014

Conditions

Traumatic Brain Injury

Keywords

TBIintracranial edemabrain edemacraniocerebral traumahead injurybrain hemorrhage, traumaticsubdural hematomabrain concussionhead injuries, closedepidural hematomaextra-axial hemorrhagecortical contusionAdditional relevant MeSH terms:Nervous System DiseasesWounds and InjuriesDisorders of Environmental OriginCentral Nervous System DiseasesTrauma, Nervous SystemBrain DiseasesBrain Injuries

Outcome Measures

Primary Outcomes (2)

  • Parent Self Report Measures

    3 years

  • Videotaped parent-child interactions

    3 years

Secondary Outcomes (1)

  • Neuropsychological testing

    3 years

Study Arms (2)

Internet Resources Comparison (IRC)

ACTIVE COMPARATOR

Participants will receive the Internet resource comparison group treatment

Behavioral: Internet Resources Comparison

I-InTERACT

EXPERIMENTAL

Participants will receive the internet-based parenting skills program.

Behavioral: Internet-based Interacting Together Everyday: Recovery After Childhood TBI

Interventions

Internet-based Interacting Together Everyday: Recovery After Childhood TBIBEHAVIORAL

Families in I-InTERACT will look through 10 web-sessions (like chapters) and participate in 10 family meetings focusing on education about traumatic brain injury, parenting skills, communication, behavior strategies, and stress management. Meetings will be conducted in their home using a computer hook-up with a trained therapist. Families will also be contacted two times per month by the counselor to discuss individual problems or concerns.

Also known as: I-InTERACT
I-InTERACT
Internet Resources ComparisonBEHAVIORAL

Families in the IRC group will receive computers, high speed internet access, and links to brain injury information and resources. The resources are available for families to access as often as they choose.

Also known as: IRC
Internet Resources Comparison (IRC)

Eligibility Criteria

Age3 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Moderate to severe TBI that occurred within the last 24 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
  • Diagnosed with moderate or severe mental retardation, autism, or a significant developmental disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Brain Injuries, TraumaticBrain EdemaCraniocerebral TraumaBrain Hemorrhage, TraumaticHematoma, SubduralBrain ConcussionHead Injuries, ClosedHematoma, Epidural, SpinalBrain ContusionNervous System DiseasesWounds and InjuriesDisorders of Environmental OriginCentral Nervous System DiseasesTrauma, Nervous SystemBrain DiseasesBrain Injuries

Condition Hierarchy (Ancestors)

Intracranial Hemorrhage, TraumaticIntracranial HemorrhagesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesHematomaHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsWounds, NonpenetratingContusions

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

January 20, 2010

First Posted

January 26, 2010

Study Start

June 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

October 28, 2014

Record last verified: 2014-09

Locations

US(1)