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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05622461
• Other study ID #: 2022-0221
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: May 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Shari Wade, PhD
• Phone: 5134610952
• Email: Shari.Wade[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Edema
• Brain Hemorrhage, Traumatic
• Brain Injuries
• Brain Injuries, Traumatic
• Craniocerebral Trauma
• Edema
• Head Injuries, Closed
• Head Injury
• Hemorrhage
• Intracranial Edema
• Intracranial Hemorrhages
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Moderators of treatment effects	Examining household income and baseline caregiver distress as moderator of treatment effects	4-6 weeks
Other	Moderators of treatment effects	Examining household income and baseline caregiver distress as moderator of treatment effects	6 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Parent resilience	Connor-Davidson Resilience Scale (CDRI); scores range from 0-40 with higher scored indicating greater resilience	Change from baseline at 6 months