Clinical trial NCT05622461: Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery
Official title: Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery, A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Brain Injury
Head Injury
Head Injuries, Closed
Brain Hemorrhage, Traumatic
Brain Edema
Intracranial Edema
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Nationwide Children's Hospital
First posted: 2022-11-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Parent anxiety
timeFrame: Change from baseline at 4-6 weeks post-intervention
measure: Parent anxiety
timeFrame: Change from baseline at 6 months
measure: Parent depression
timeFrame: Change from baseline at 4-6 weeks post-intervention
measure: Parent depression
timeFrame: Change from baseline at 6 months
measure: Parenting self-efficacy
timeFrame: Change from baseline at 4-6 weeks post-intervention
measure: Parenting self-efficacy
timeFrame: Change from baseline at 6 months
measure: Parent post-traumatic symptoms
timeFrame: Change from baseline at 4-6 weeks post-intervention
measure: Parent post-traumatic symptoms
timeFrame: Change from baseline at 6 months
Secondary outcomes:
measure: Family Functioning
timeFrame: Change from baseline at 4-6 weeks post-intervention
measure: Family Functioning
timeFrame: Change from baseline at 6 months
measure: Family Burden of Injury
timeFrame: Change from baseline at 4-6 weeks post-intervention
measure: Family Burden of Injury
timeFrame: Change from baseline at 6 months
measure: Child Socioemotional Functioning
timeFrame: Change from baseline at 4-6 weeks post-intervention
measure: Child Socioemotional Functioning
timeFrame: Change from baseline at 6 months
measure: Parent mindful self-care
timeFrame: Change from baseline at 4-6 weeks post-intervention
measure: Parent mindful self-care
timeFrame: Change from baseline at 6 months
measure: Parent resilience
timeFrame: Change from baseline at 4-6 weeks post-intervention
measure: Parent resilience
timeFrame: Change from baseline at 6 months
Other outcomes:
measure: Moderators of treatment effects
timeFrame: 4-6 weeks
measure: Moderators of treatment effects
timeFrame: 6 months
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: CCHMC
name: Shari Wade, PhD
role: PRINCIPAL_INVESTIGATOR
References: