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NCT Number: NCT05622461

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

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).

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Edema Brain Hemorrhage, Traumatic Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Head Injuries, Closed Head Injury Intracranial Edema Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Nervous System Diseases Trauma, Nervous System Vascular Diseases Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Road-to-recovery

Behavioral

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.

Primary outcomes

  1. Parent anxiety

    Time frame: Change from baseline at 4-6 weeks post-intervention

    Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Measure 4a; scores range from 4-20 with higher score indicating greater symptoms of anxiety

  2. Parent anxiety

    Time frame: Change from baseline at 6 months

    Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Measure 4a; scores range from 4-20 with higher score indicating greater symptoms of anxiety

  3. Parent depression

    Time frame: Change from baseline at 4-6 weeks post-intervention

    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

  4. Parent depression

    Time frame: Change from baseline at 6 months

    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

  5. Parenting self-efficacy

    Time frame: Change from baseline at 4-6 weeks post-intervention

    Caregiver self-efficacy scale (CSES); scores range from 25-100, higher scores indicate greater parenting self efficacy

  6. Parenting self-efficacy

    Time frame: Change from baseline at 6 months

    Caregiver self-efficacy scale (CSES); scores range from 25-100, higher scores indicate greater parenting self efficacy

  7. Parent post-traumatic symptoms

    Time frame: Change from baseline at 4-6 weeks post-intervention

    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

  8. Parent post-traumatic symptoms

    Time frame: Change from baseline at 6 months

    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

Secondary outcomes

  1. Family Functioning

    Time frame: Change from baseline at 4-6 weeks post-intervention

    Family Assessment Device - Global Functioning Scale. Scores range from 1 to 4 with higher scores indicating poorer family functioning

  2. Family Functioning

    Time frame: Change from baseline at 6 months

    Family Assessment Device - Global Functioning Scale. Scores range from 1 to 4 with higher scores indicating poorer family functioning

  3. Family Burden of Injury

    Time frame: Change from baseline at 4-6 weeks post-intervention

    Family Burden of Injury Interview (FBII). Average scores range from 0-4; higher scores indicate greater injury-related burden

  4. Family Burden of Injury

    Time frame: Change from baseline at 6 months

    Family Burden of Injury Interview (FBII). Average scores range from 0-4; higher scores indicate greater injury-related burden

  5. Child Socioemotional Functioning

    Time frame: Change from baseline at 4-6 weeks post-intervention

    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)

  6. Child Socioemotional Functioning

    Time frame: Change from baseline at 6 months

    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)

  7. Parent mindful self-care

    Time frame: Change from baseline at 4-6 weeks post-intervention

    Mindful self-care scale (MSCS); scores range from 6 - 30, higher scores denote greater frequency in engaging in self-care behaviors

  8. Parent mindful self-care

    Time frame: Change from baseline at 6 months

    Mindful self-care scale (MSCS); scores range from 6 - 30, higher scores denote greater frequency in engaging in self-care behaviors

  9. Parent resilience

    Time frame: Change from baseline at 4-6 weeks post-intervention

    Connor-Davidson Resilience Scale (CDRI); scores range from 0-40 with higher scored indicating greater resilience

  10. Parent resilience

    Time frame: Change from baseline at 6 months

    Connor-Davidson Resilience Scale (CDRI); scores range from 0-40 with higher scored indicating greater resilience

Other outcomes

  1. Moderators of treatment effects

    Time frame: 4-6 weeks

    Examining household income and baseline caregiver distress as moderator of treatment effects

  2. Moderators of treatment effects

    Time frame: 6 months

    Examining household income and baseline caregiver distress as moderator of treatment effects

Study contacts

Contact information is provided by the study sponsor or research team.

Shari Wade, PhD

CONTACT

[email protected]

5134610952

Stacey Raj

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Nationwide Children's Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2022
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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