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

Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery, A Randomized Control Trial

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).

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury; Head Injuries, Closed; Head Injury; Brain Edema; Brain Hemorrhage, Traumatic; Intracranial Edema
• Intervention / Treatment: Behavioral: Road-to-recovery

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shari Wade, PhD; Phone Number: 5134610952; Email: Shari.Wade@cchmc.org
• Study Contact Backup: Name: Stacey Raj; Email: rajs@xavier.edu

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229-3036
      • Recruiting
      • Cincinnati Children's Hospital Medical Center
      • Contact: Stacey Raj; Email: rajs@xavier.edu
      • Contact: Shari Wade; Phone Number: 513-461-0952; Email: Shari.Wade@cchmc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Road-to-recovery group (R2R); Usual medical care plus the R2R-TBI intervention (self-guided web-program)	Behavioral: 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.
Active Comparator: Internet resources comparison group (IRC); Usual medical care plus internet resources	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family Functioning	Family Assessment Device - Global Functioning Scale. Scores range from 1 to 4 with higher scores indicating poorer family functioning	Change from baseline at 4-6 weeks post-intervention
Family Functioning	Family Assessment Device - Global Functioning Scale. Scores range from 1 to 4 with higher scores indicating poorer family functioning	Change from baseline at 6 months
Family Burden of Injury	Family Burden of Injury Interview (FBII). Average scores range from 0-4; higher scores indicate greater injury-related burden	Change from baseline at 4-6 weeks post-intervention
Family Burden of Injury	Family Burden of Injury Interview (FBII). Average scores range from 0-4; higher scores indicate greater injury-related burden	Change from baseline at 6 months
Child Socioemotional Functioning	Pediatric Quality of Life Scale (PEDS-QL) - Psychosocial Health Summary Score (score range varies based on child age; higher scores indicate greater health related quality of life)	Change from baseline at 4-6 weeks post-intervention
Child Socioemotional Functioning	Pediatric Quality of Life Scale (PEDS-QL) - Psychosocial Health Summary Score (score range varies based on child age; higher scores indicate greater health related quality of life)	Change from baseline at 6 months
Parent mindful self-care	Mindful self-care scale (MSCS); scores range from 6 - 30, higher scores denote greater frequency in engaging in self-care behaviors	Change from baseline at 4-6 weeks post-intervention
Parent mindful self-care	Mindful self-care scale (MSCS); scores range from 6 - 30, higher scores denote greater frequency in engaging in self-care behaviors	Change from baseline at 6 months
Parent resilience	Connor-Davidson Resilience Scale (CDRI); scores range from 0-40 with higher scored indicating greater resilience	Change from baseline at 4-6 weeks post-intervention
Parent resilience	Connor-Davidson Resilience Scale (CDRI); scores range from 0-40 with higher scored indicating greater resilience	Change from baseline at 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moderators of treatment effects	Examining household income and baseline caregiver distress as moderator of treatment effects	4-6 weeks
Moderators of treatment effects	Examining household income and baseline caregiver distress as moderator of treatment effects	6 months

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Nationwide Children's Hospital
• Investigators: Principal Investigator: Shari Wade, PhD, CCHMC

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds, Nonpenetrating; Intracranial Hemorrhage, Traumatic; Brain Injuries; Wounds and Injuries; Hemorrhage; Brain Injuries, Traumatic; Edema; Intracranial Hemorrhages; Craniocerebral Trauma; Brain Edema; Head Injuries, Closed; Brain Hemorrhage, Traumatic
• Other Study ID Numbers: 2022-0221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Plan is to share deidentified data as consistent with requirement of funding source (i.e., The National Institute on Disability and Rehabilitation Research).
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No