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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05622461
Other study ID # 2022-0221
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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