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A parent-led intervention to promote recovery following pediatric injury: study protocol for a randomized controlled
Meghan L Marsac1,2, Ginny Sprang3,4, Leila Guller5,6
1Department of Pediatrics, Kentucky Children's Hospital, Lexington, KY, USA. meghan.marsac@uky.edu.
Insights
This study evaluates the Cellie Coping Kit, a parent-guided intervention designed to improve physical and emotional recovery in injured children. The kit aims to enhance coping skills and overall health outcomes following pediatric injury.
Area of Science:
- Pediatric injury recovery
- Child psychology
- Intervention science
Background:
- Pediatric injury is a common traumatic event impacting children's physical and emotional health.
- Existing interventions lack accessibility for all injured children.
- The Cellie Coping Kit was developed using evidence-based strategies and expert feedback.
Purpose of the Study:
- To evaluate the impact of the Cellie Coping Kit intervention on children's coping and appraisals.
- To assess the intervention's effect on child health outcomes, including physical recovery, emotional health, and quality of life.
- To provide an initial evaluation of a novel parent-guided intervention for pediatric injury recovery.
Main Methods:
- Pilot randomized controlled trial with 80 children (aged 8-12) and their parents.
- Participants randomly assigned to immediate intervention or waitlist control group.
- Assessments conducted at baseline, 6, 12, and 18 weeks, measuring coping, appraisals, physical health, and emotional well-being.
Main Results:
- The study aims to provide initial data on the feasibility and efficacy of the Cellie Coping Kit.
- Proximal outcomes (coping, appraisals) and distal outcomes (health, quality of life) will be analyzed.
- Results will inform future research and clinical implementation of the intervention.
Conclusions:
- This is one of the first randomized controlled trials for a parent-implemented intervention promoting pediatric injury recovery.
- The study will offer insights into the feasibility and estimated efficacy of the Cellie Coping Kit.
- Findings will guide the refinement and broader application of the intervention for injured children.
Background:
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).
Method / Design:
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).
Discussion:
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.
Trial Registration:
Clinicaltrials.gov, NCT03153696 . Registered on 15 May 2017.
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