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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Parent anxiety [Срок оценки: Change from baseline at 4-6 weeks post-intervention]
• Parent anxiety [Срок оценки: Change from baseline at 6 months]
• Parent depression [Срок оценки: Change from baseline at 4-6 weeks post-intervention]
• Parent depression [Срок оценки: Change from baseline at 6 months]
• Parenting self-efficacy [Срок оценки: Change from baseline at 4-6 weeks post-intervention]
• Parenting self-efficacy [Срок оценки: Change from baseline at 6 months]
• Parent post-traumatic symptoms [Срок оценки: Change from baseline at 4-6 weeks post-intervention]
• Parent post-traumatic symptoms [Срок оценки: Change from baseline at 6 months]

Вторичные конечные точки (10)

• Family Functioning [Срок оценки: Change from baseline at 4-6 weeks post-intervention]
• Family Functioning [Срок оценки: Change from baseline at 6 months]
• Family Burden of Injury [Срок оценки: Change from baseline at 4-6 weeks post-intervention]
• Family Burden of Injury [Срок оценки: Change from baseline at 6 months]
• Child Socioemotional Functioning [Срок оценки: Change from baseline at 4-6 weeks post-intervention]
• Child Socioemotional Functioning [Срок оценки: Change from baseline at 6 months]
• Parent mindful self-care [Срок оценки: Change from baseline at 4-6 weeks post-intervention]
• Parent mindful self-care [Срок оценки: Change from baseline at 6 months]
• Parent resilience [Срок оценки: Change from baseline at 4-6 weeks post-intervention]
• Parent resilience [Срок оценки: Change from baseline at 6 months]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Cincinnati Children's Hospital Medical Center — Cincinnati

Идентификаторы

NCT: NCT05622461 · 2022-0221

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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