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

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Traumatic Brain Injury

Treatments: Behavioral: Internet-based Interacting Together Everyday: Recovery After Childhood TBI (I-InTERACT); Behavioral: Internet Resources Comparison (IRC); Behavioral: Internet-based-Interacting Together Everyday, Recovery after Childhood TBI Express (I-InTERACT Express)

Study type: Interventional

Funder types: Other

Identifiers

NCT01214694

H133B090010--02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 117 patients

Sex: All

Ages: 3 to 9 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

117 participants in 3 patient groups

Active Comparator: Internet Resources Comparison (IRC)

Experimental group

Description:

Participants will receive the Internet resource comparison group treatment

Treatment:

Behavioral: Internet Resources Comparison (IRC)

I-InTERACT

Experimental group

Description:

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

Treatment:

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

I-InTERACT Express

Experimental group

Description:

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

Treatment:

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