Internet-based Interacting Together Everyday, Recovery After Childhood TBI (I-InTERACT)--RRTC

NCT ID: NCT01214694

Last Updated: 2016-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2015-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Comparator: Internet Resources Comparison (IRC)

Participants will receive the Internet resource comparison group treatment

Group Type: EXPERIMENTAL

Internet Resources Comparison (IRC)

Intervention Type: 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.

I-InTERACT

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

I-InTERACT Express

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

Internet-based Interacting Together Everyday: Recovery After Childhood TBI (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.

Intervention Type: BEHAVIORAL

Internet-based-Interacting Together Everyday, Recovery after Childhood TBI Express (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.

Intervention Type: BEHAVIORAL

Internet Resources Comparison (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.

Intervention Type: BEHAVIORAL

Other Intervention Names

I-InTERACT; I-InTERACT Express; IRC

Eligibility Criteria

Inclusion Criteria

• Moderate to severe TBI that occurred within the last 24 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
• 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MetroHealth Medical Center

OTHER

Sponsor Role: collaborator

Nationwide Children's Hospital

OTHER

Sponsor Role: collaborator

Rainbow Babies and Children's Hospital

OTHER

Sponsor Role: collaborator

Children's Hospital Colorado

OTHER

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shari L Wade, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

H. Gerry Taylor, PhD

Role: PRINCIPAL_INVESTIGATOR

Rainbow Babies and Children's Hospital

Keith O. Yeates, PhD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Michael Kirkwood, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado

Terry Stancin, PhD

Role: PRINCIPAL_INVESTIGATOR

MetroHealth Medical Center

Locations

The Children's Hospital, Denver

Aurora, Colorado, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30499926 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29096775 (View on PubMed)

Other Identifiers

H133B090010--02

Identifier Type: -

Identifier Source: org_study_id