A parent-led intervention to promote recovery following pediatric injury: study protocol for a randomized controlled trial

• Published in: Current controlled trials in cardiovascular medicine Vol. 20; no. 1; pp. 137 - 11
• Main Authors: Marsac, Meghan L, Sprang, Ginny, Guller, Leila, Kohser, Kristen L, Draus, Jr, John M, Kassam-Adams, Nancy
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 18.02.2019; BioMed Central; BMC
• Subjects: Adaptation, Psychological; Age Factors; Analysis; Appraisals; Care and treatment; Caregivers; Cellie Coping Kit; Child; Child Behavior; Child health; Child injury; Children; Children & youth; Childrens health; Clinical trials; Cognitive models; Coping; Early intervention; Emergency medical care; Emotional health; Emotions; Families & family life; Family; Female; Humans; Injuries; Intervention; Kentucky; Male; Mental health; Parent-Child Relations; Parents & parenting; Parents - psychology; Patient Participation; Pediatric injuries; Pediatric research; Pediatrics; Pilot Projects; Play and Playthings; Randomized Controlled Trials as Topic; Recovery (Medical); Study Protocol; Time Factors; Trauma; Treatment Outcome; Wounds and Injuries - diagnosis; Wounds and Injuries - physiopathology; Wounds and Injuries - psychology; Wounds and Injuries - therapy; Kentucky; United States > US; Early intervention; Cellie Coping Kit; Emotional health; Child injury; Parent intervention; Coping; Appraisals
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-019-3207-9

Injury is one of the most prevalent potentially emotionally traumatic events that children experience and can lead to persistent impaired physical and emotional health. There is a need for interventions that promote full physical and emotional recovery and that can be easily accessed by all injured children. Based on research evidence regarding post-injury recovery, we created the Cellie Coping Kit for Children with Injury intervention to target key mechanisms of action and refined the intervention based on feedback from children, families, and experts in the field. The Cellie Coping Kit intervention is parent-guided and includes a toy (for engagement), coping cards for children, and a book for parents with evidence-based strategies to promote injury recovery. This pilot research trial aims to provide an initial evaluation of the impact of the Cellie Coping Kit for Children with Injury on proximal targets (coping, appraisals) and later child health outcomes (physical recovery, emotional health, health-related quality of life). Eighty children (aged 8-12 years) and their parents will complete a baseline assessment (T1) and then will be randomly assigned to an immediate intervention group or waitlist group. The Cellie Coping Kit for Injury Intervention will be introduced to the immediate intervention group after the T1 assessment and to the waitlist group following the T3 assessment. Follow-up assessments of physical and emotional health will be completed at 6 weeks (T2), 12 weeks (T3), and 18 weeks (T4). This will be one of the first randomized controlled trials to examine an intervention tool intended to promote full recovery after pediatric injury and be primarily implemented by children and parents. Results will provide data on the feasibility of the implementation of the Cellie Coping Intervention for Injury as well as estimations of efficacy. Potential strengths and limitations of this design are discussed. Clinicaltrials.gov, NCT03153696 . Registered on 15 May 2017.