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

Cincinnati Children's Hospital Medical Center

Status: Enrolling

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

Treatments: Behavioral: Road-to-recovery

Study type: Interventional

Funder types: Other

Identifiers

NCT05622461

2022-0221

Details and patient eligibility

About

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).

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

200 participants in 2 patient groups

Road-to-recovery group (R2R)

Experimental group

Description:

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

Treatment:

Behavioral: Road-to-recovery

Internet resources comparison group (IRC)

Active Comparator group

Description:

Usual medical care plus internet resources

Treatment:

Behavioral: Road-to-recovery