Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery

NCT ID: NCT05622461

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-13
• Study Completion Date: 2026-08-31

Brief Summary

This study has two main goals: 1) to refine and enhance the R2R-TBI intervention; and 2) to examine the efficacy of the R2R-TBI intervention in a randomized control trial. To achieve the second goal, we will employ a between-groups randomized treatment design with repeated measures at baseline, one-month post-randomization, and at a six-month follow-up. The two conditions will be: a) usual medical care plus access to internet resources regarding pediatric brain injury (Internet Resources Comparison group, IRC), and b) usual medical care plus the R2R-TBI intervention (Road-to-Recovery group, R2R-TBI).

Detailed Description

The early recovery period constitutes a critical window to set families on a positive road-to-recovery by supporting parental self-care, positive parent-child interactions, and awareness of potential longer-term concerns. The latter would facilitate parental recognition of behavioral and psychosocial needs that might otherwise go unmet.

Recognizing that (1) caregivers of children who have sustained TBI are at risk of worsening psychological health and that (2) caregiver functioning and parenting behaviors have a direct impact on child recovery and outcomes; intervening and supporting caregivers in the acute phase following injury may set children and families on a positive path to recovery. Intervening at the acute phase may reduce the cascading effects of parental burden/distress and concomitant negative parent-child interactions on child recovery and functioning over time.

Because families of children with TBI and other chronic health conditions may have difficulty accessing services due to transportation and cost issues, particularly lower income families, the R2R-TBI program is designed to be accessed via any web-enabled device (e.g., smartphone, computer, tablet) with any form of internet connection. We will also offer the intervention (via tablet) to parents while they wait for their child to complete outpatient therapies (e.g., speech, physical, and occupational therapy). Delivery of web-based behavioral health interventions may reduce barriers to help-seeking and promote evidence-based interventions that are both accessible and efficient.

Conditions

Traumatic Brain Injury; Head Injury; Head Injuries, Closed; Brain Hemorrhage, Traumatic; Brain Edema; Intracranial Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Road-to-recovery group (R2R)

Usual medical care plus the R2R-TBI intervention (self-guided web-program)

Group Type: EXPERIMENTAL

Road-to-recovery

Intervention Type: BEHAVIORAL

R2R-TBI is a self-guided web-based intervention that targets caregiver psychological functioning, parenting behaviors, and family functioning in the first three months following pediatric traumatic brain injury.

Internet resources comparison group (IRC)

Usual medical care plus internet resources

Group Type: ACTIVE_COMPARATOR

Road-to-recovery

Intervention Type: BEHAVIORAL

R2R-TBI is a self-guided web-based intervention that targets caregiver psychological functioning, parenting behaviors, and family functioning in the first three months following pediatric traumatic brain injury.

Interventions

Road-to-recovery

R2R-TBI is a self-guided web-based intervention that targets caregiver psychological functioning, parenting behaviors, and family functioning in the first three months following pediatric traumatic brain injury.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Caregivers will be eligible if they are over 18 years of age, and if their child meets all of the following criteria:

• Ages 3 months to 18 years at time of discharge from hospital
• Sustained a complicated mild to severe TBI as defined by a Glasgow Coma Scale (GCS) of 13-15 with imagining abnormalities or GCS 3-12 with or without imaging abnormalities
• Admitted overnight to the hospital
• 0-3 months post-discharge

Exclusion Criteria

The caregiver will be excluded from participation if any of the following occur:

• Child did not survive the injury
• Child sustained a non-blunt head trauma (e.g. gunshot wound)
• Child does not reside with parent/caregiver for study duration
• English is not primary language spoken in the home

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nationwide Children's Hospital

OTHER

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shari Wade, PhD

Role: PRINCIPAL_INVESTIGATOR

CCHMC

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shari Wade, PhD

Role: CONTACT

Shari.Wade@cchmc.org

5134610952

Stacey Raj

Role: CONTACT

rajs@xavier.edu

Facility Contacts

Shari Wade

Role: primary

Shari.Wade@cchmc.org

5134610952

Stacey Raj

Role: backup

rajs@xavier.edu

Other Identifiers

2022-0221

Identifier Type: -

Identifier Source: org_study_id