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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

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

Intervention / Treatment
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* Behavioral: Road-to-recovery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |