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

NCT05622461 | Recruiting

• 1 other identifier: 2022-0221
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (8)

• Parent anxiety

  Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Measure 4a; scores range from 4-20 with higher score indicating greater symptoms of anxiety

  Change from baseline at 4-6 weeks post-intervention

• Parent anxiety

  Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Measure 4a; scores range from 4-20 with higher score indicating greater symptoms of anxiety

  Change from baseline at 6 months

• Parent depression

  Center for Epidemiological Studies Depression Scale (CES-D; 10-items); scores range from 0 -30 with higher scores indicating of higher levels of depressive symptomatology

  Change from baseline at 4-6 weeks post-intervention

• Parent depression

  Center for Epidemiological Studies Depression Scale (CES-D; 10-items); scores range from 0 -30 with higher scores indicating of higher levels of depressive symptomatology

  Change from baseline at 6 months

• Parenting self-efficacy

  Caregiver self-efficacy scale (CSES); scores range from 25-100, higher scores indicate greater parenting self efficacy

  Change from baseline at 4-6 weeks post-intervention

• Parenting self-efficacy

  Caregiver self-efficacy scale (CSES); scores range from 25-100, higher scores indicate greater parenting self efficacy

  Change from baseline at 6 months

• Parent post-traumatic symptoms

  Primary Care PTSD Screen for DSM-5 (PC-PTSD-5); scores rage from 0-5 with higher scores indicating greater experience of post-traumatic stress symptoms

  Change from baseline at 4-6 weeks post-intervention

• Parent post-traumatic symptoms

  Primary Care PTSD Screen for DSM-5 (PC-PTSD-5); scores rage from 0-5 with higher scores indicating greater experience of post-traumatic stress symptoms

  Change from baseline at 6 months

Secondary Outcomes (10)

• Family Functioning

  Change from baseline at 4-6 weeks post-intervention

• Family Functioning

  Change from baseline at 6 months

• Family Burden of Injury

  Change from baseline at 4-6 weeks post-intervention

• Family Burden of Injury

  Change from baseline at 6 months

• Child Socioemotional Functioning

  Change from baseline at 4-6 weeks post-intervention

Other Outcomes (2)

• Moderators of treatment effects

  4-6 weeks

• Moderators of treatment effects

  6 months

Study Arms (2)

Road-to-recovery group (R2R)

EXPERIMENTAL

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

Behavioral: Road-to-recovery

Internet resources comparison group (IRC)

ACTIVE COMPARATOR

Usual medical care plus internet resources

Behavioral: Road-to-recovery

Interventions

Road-to-recovery 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); Road-to-recovery group (R2R)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• months post-discharge

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Nationwide Children's Hospital: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3036, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Craniocerebral Trauma; Head Injuries, Closed; Brain Hemorrhage, Traumatic; Brain Edema

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Wounds, Nonpenetrating; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Shari Wade, PhD

  CCHMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shari Wade, PhD

CONTACT

5134610952; Shari.Wade@cchmc.org

Stacey Raj

CONTACT

rajs@xavier.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 18, 2022
• Study Start: February 13, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 6 months after publication
• Access Criteria: Plan is to share deidentified data as consistent with protocols of funding source (i.e., The National Institute on Disability and Rehabilitation Research).

Locations

US (1)