NCT01214694

Brief Summary

The purpose of this study is to test two on-line interventions for families of young children who have experienced moderate or severe traumatic brain injury (TBI). 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 groups 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
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

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

October 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 5, 2010

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

6.2 years

First QC Date

September 1, 2010

Last Update Submit

March 7, 2016

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 (1)

  • Parent Report Measures

    5 years

Secondary Outcomes (1)

  • Neuropsychological Testing

    5 years

Study Arms (3)

Active Comparator: Internet Resources Comparison (IRC)

EXPERIMENTAL

Participants will receive the Internet resource comparison group treatment

Behavioral: Internet Resources Comparison (IRC)

I-InTERACT

EXPERIMENTAL

Participants will receive a 24 week, 27 session internet-based parenting skills program

Behavioral: Internet-based Interacting Together Everyday: Recovery After Childhood TBI (I-InTERACT)

I-InTERACT Express

EXPERIMENTAL

Participants will receive an abbreviated 7 week, 14 session version of the I-InTERACT parenting skills program.

Behavioral: Internet-based-Interacting Together Everyday, Recovery after Childhood TBI Express (I-InTERACT Express)

Interventions

Internet-based Interacting Together Everyday: Recovery After Childhood TBI (I-InTERACT)BEHAVIORAL

Families in I-InTERACT will view 10 web-sessions (like chapters) and participate in 27 family meetings over the course of 24 weeks focusing on increasing positive parenting skills, reducing parenting stress, and improving child behavior problems. Meetings will be conducted in their home using a computer hook-up with a trained therapist.

Also known as: I-InTERACT
I-InTERACT
Internet-based-Interacting Together Everyday, Recovery after Childhood TBI Express (I-InTERACT Express)BEHAVIORAL

Families in I-InTERACT Express will view 10 web-sessions (like chapters) and participate in 14 family meetings over the course of 7 weeks focusing on increasing positive parenting skills, reducing parenting stress, and improving child behavior problems. Meetings will be conducted in their home using a computer hook-up with a trained therapist.

Also known as: I-InTERACT Express
I-InTERACT Express
Internet Resources Comparison (IRC)BEHAVIORAL

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
Active Comparator: 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
  • Child suffered a non-blunt 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

The Children's Hospital, Denver

Aurora, Colorado, 80045, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (2)

  • Aguilar JM, Cassedy AE, Shultz EL, Kirkwood MW, Stancin T, Yeates KO, Taylor HG, Wade SL. A Comparison of 2 Online Parent Skills Training Interventions for Early Childhood Brain Injury: Improvements in Internalizing and Executive Function Behaviors. J Head Trauma Rehabil. 2019 Mar/Apr;34(2):65-76. doi: 10.1097/HTR.0000000000000443.

    PMID: 30499926DERIVED

  • Wade SL, Cassedy AE, Shultz EL, Zang H, Zhang N, Kirkwood MW, Stancin T, Yeates KO, Taylor HG. Randomized Clinical Trial of Online Parent Training for Behavior Problems After Early Brain Injury. J Am Acad Child Adolesc Psychiatry. 2017 Nov;56(11):930-939.e2. doi: 10.1016/j.jaac.2017.09.413. Epub 2017 Sep 14.

    PMID: 29096775DERIVED

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

  • H. Gerry Taylor, PhD

    Rainbow Babies and Children's Hospital

    PRINCIPAL INVESTIGATOR

  • Keith O. Yeates, PhD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

  • Michael Kirkwood, PhD

    Children's Hospital Colorado

    PRINCIPAL INVESTIGATOR

  • Terry Stancin, PhD

    MetroHealth Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2010

First Posted

October 5, 2010

Study Start

October 1, 2009

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 8, 2016

Record last verified: 2016-03

Locations

US(5)