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
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).
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 |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati | Nationwide Children's Hospital |
United States,
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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