Traumatic Brain InjuryI-InTERACTNCT01214694
Internet-based Interacting Together Everyday, Recovery After Childhood TBI (I-InTERACT)--RRTC
A study testing Internet-based Interacting Together Everyday: Recovery After Childhood TBI (I-InTERACT), Internet-based-Interacting Together Everyday, Recovery after Childhood TBI Express (I-InTERACT Express) and Internet Resources Comparison (IRC) in people with Traumatic Brain Injury, run by Children's Hospital Medical Center, Cincinnati at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Internet-based Interacting Together Everyday: Recovery After Childhood TBI (I-InTERACT), Internet-based-Interacting Together Everyday, Recovery after Childhood TBI Express (I-InTERACT Express) and Internet Resources Comparison (IRC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2009to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Moderate to severe TBI that occurred within the last 24 months
- Overnight hospital stay
- English-speaking
- Parent must be willing to provide informed consent
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Children's Hospital, Denver
Aurora, Colorado, 80045
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
MetroHealth Medical Center
Cleveland, Ohio, 44109
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Internet-based Interacting Together Everyday, Recovery After Childhood TBI
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.
Read the detailed description
The investigators will conduct a multi-site randomized controlled trial (RCT) comparing the efficacy of 7-week Internet-based Interacting Together Everyday, Recovery after Childhood Traumatic Brain Injury Express (I-InTERACT Express) and 24-week long web-based positive parenting skills programs Internet-based Interacting Together Everyday, Recovery after Childhood Traumatic Brain Injury (I-InTERACT) to an internet resource group (IRC) involving access to internet resources and education about brain injury. The project builds upon the feasibility and efficacy findings from an ongoing randomized trial comparing the efficacy of a 24-week positive parenting skills program to access to internet resources. However, it differs in size and scope by including multiple sites, and by including an abbreviated parenting skills training arm in response to family feedback that the existing 24-week intervention was excessively long, resulting in adherence difficulties. The investigators anticipate that the improvements in parenting skills and psychological functioning will translate into improved parent-child relationships and reductions in child behavior problems. Over time, such improvements in child and parent functioning should contribute to academic and social success and more successful community integration.
- Conditions
- Traumatic Brain Injury
- Being tested
- Internet-based Interacting Together Everyday: Recovery After Childhood TBI (I-InTERACT), Internet-based-Interacting Together Everyday, Recovery after Childhood TBI Express (I-InTERACT Express), Internet Resources Comparison (IRC)
- 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, Additional relevant MeSH terms:, Nervous System Diseases, Wounds and Injuries, Disorders of Environmental Origin, Central Nervous System Diseases, Trauma, Nervous System, Brain Diseases, Brain Injuries
- Medical subject headings
- Brain Injuries, Traumatic, Brain Edema, Craniocerebral Trauma, Brain Hemorrhage, Traumatic, Hematoma, Subdural, Brain Concussion, Head Injuries, Closed, Hematoma, Epidural, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based Interacting Together Everyday: Recovery After Childhood TBI (I-InTERACT)Behavioural
Also called I-InTERACT
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.
Internet-based-Interacting Together Everyday, Recovery after Childhood TBI Express (I-InTERACT Express)Behavioural
Also called I-InTERACT Express
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.
Internet Resources Comparison (IRC)Behavioural
Also called IRC
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Internet Resources Comparison (IRC) | Experimental | Participants will receive the Internet resource comparison group treatment Receives: Behavioral: Internet Resources Comparison (IRC) |
| I-InTERACT | Experimental | Participants will receive a 24 week, 27 session internet-based parenting skills program Receives: 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. Receives: Behavioral: Internet-based-Interacting Together Everyday, Recovery after Childhood TBI Express (I-InTERACT Express) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent Report Measures
Measured: 5 years
Secondary outcomes (1)
Neuropsychological Testing
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2010 (estimated)
- Study startOct 2009
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- MetroHealth Medical Center, Nationwide Children's Hospital, Rainbow Babies and Children's Hospital, Children's Hospital Colorado
- Responsible party
- Sponsor
- Investigators
- Shari L Wade, PhD, Principal investigator, Children's Hospital Medical Center, CincinnatiH. Gerry Taylor, PhD, Principal investigator, Rainbow Babies and Children's HospitalKeith O. Yeates, PhD, Principal investigator, Nationwide Children's HospitalMichael Kirkwood, PhD, Principal investigator, Children's Hospital ColoradoTerry Stancin, PhD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214694
- Sponsor's protocol ID
- H133B090010--02
- Acronym
- I-InTERACT
- Status last verified
- Mar 2016
- First submitted
- 1 Sep 2010
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30499926Wade 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.
PubMed 29096775
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Research and Training Center for Traumatic Brain Injury Interventions--Internet-based Interacting Together Everyday, Recovery After Childhood TBI
- ClinicalTrials.gov ID
- NCT01214694
- Acronym / sponsor ID
- I-InTERACT / H133B090010--02
- Conditions
- Traumatic Brain Injury
- Keywords
- TBI, intracranial edema, brain edema, craniocerebral trauma, head injury, brain hemorrhage, traumatic, subdural hematoma, brain concussion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- MetroHealth Medical Center, Nationwide Children's Hospital, Rainbow Babies and Children's Hospital, Children's Hospital Colorado
- Study start
- Oct 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators will conduct a multi-site randomized controlled trial (RCT) comparing the efficacy of 7-week Internet-based Interacting Together Everyday, Recovery after Childhood Traumatic Brain Injury Express (I-InTERACT Express) and 24-week long web-based positive parenting skills programs Internet-based Interacting Together Everyday, Recovery after Childhood Traumatic Brain Injury (I-InTERACT) to an internet resource group (IRC) involving access to internet resources and education about brain injury. The project builds upon the feasibility and efficacy findings from an ongoing randomized trial comparing the efficacy of a 24-week positive parenting skills program to access to internet resources. However, it differs in size and scope by including multiple sites, and by including an abbreviated parenting skills training arm in response to family feedback that the existing 24-week intervention was excessively long, resulting in adherence difficulties. The investigators anticipate that the improvements in parenting skills and psychological functioning will translate into improved parent-child relationships and reductions in child behavior problems. Over time, such improvements in child and parent functioning should contribute to academic and social success and more successful community integration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Internet Resources Comparison (IRC) | Experimental | Behavioral: Internet Resources Comparison (IRC)Participants will receive the Internet resource comparison group treatment |
| I-InTERACT | Experimental | Behavioral: Internet-based Interacting Together Everyday: Recovery After Childhood TBI (I-InTERACT)Participants will receive a 24 week, 27 session internet-based parenting skills program |
| I-InTERACT Express | Experimental | Behavioral: Internet-based-Interacting Together Everyday, Recovery after Childhood TBI Express (I-InTERACT Express)Participants will receive an abbreviated 7 week, 14 session version of the I-InTERACT parenting skills program. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Moderate to severe TBI that occurred within the last 24 months
- Overnight hospital stay
- English-speaking
- Parent must be willing to provide informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based Interacting Together Everyday: Recovery After Childhood TBI (I-InTERACT)Also: I-InTERACTFamilies 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. | Behavioural | I-InTERACT |
| Internet-based-Interacting Together Everyday, Recovery after Childhood TBI Express (I-InTERACT Express)Also: I-InTERACT ExpressFamilies 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. | Behavioural | I-InTERACT Express |
| Internet Resources Comparison (IRC)Also: IRCFamilies 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. | Behavioural | Active Comparator: Internet Resources Comparison (IRC) |
Primary outcome
Parent Report Measures
Time frame: 5 years
1 secondary outcome
Neuropsychological Testing
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Derived from this study: PubMed 30499926Aguilar 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.
- Derived from this study: PubMed 29096775Wade 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shari L Wade, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
H. Gerry Taylor, PhD principal investigator
Rainbow Babies and Children's Hospital
Keith O. Yeates, PhD principal investigator
Nationwide Children's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based Interacting Together Everyday: Recovery After Childhood TBI (I-InTERACT), Internet-based-Interacting Together Everyday, Recovery after Childhood TBI Express (I-InTERACT Express) and Internet Resources Comparison (IRC) in people with Traumatic Brain Injury, run by Children's Hospital Medical Center, Cincinnati at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Report Measures (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01214694, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.