The purpose of this study is to assess the feasibility (fidelity, acceptability, implementation, cost) of the Cellie Coping Kit for Children with Injury as well as to determine the intervention's efficacy (mechanisms of action and health outcomes).
The goal of this study is to assess the Cellie Coping Kit for Injury intervention feasibility and initial efficacy. Aim 1: Intervention Feasibility Assess intervention feasibility (implementation, cost, fidelity). Aim 2: Intervention Efficacy (Mechanisms of Action and Health Outcomes): Conduct initial efficacy evaluation of the Cellie Intervention on mechanisms of action (adherence and coping behaviors) and health outcomes (physical recovery, HRQOL, emotional health). Hypotheses: At 6-week follow-up (T2), compared to a Treatment as Usual (TAU) control group, parents in the intervention group will report greater adherence to medical discharge instructions (H2.1) and encourage their child to use a higher number of adaptive coping strategies (cognitive, active, support seeking; H2.2); children in the intervention group will generate a greater number of adaptive coping strategies (H2.3). Hypotheses: At a 12-week follow-up (T3), compared to TAU, children in the intervention group will report better HRQOL and emotional health (H2.4); parents in the intervention group will report better child HRQOL and child emotional health (H2.5). Objective injury recovery scores will be higher for the intervention group (H2.6). Method: 80 children with injury and one parent per child will participate in a pilot RCT with a wait-list control design. Participants will complete baseline assessments of targeted study variables prior to randomization (40 to the intervention; 40 to usual care) and then repeat measures 6 (T2), 12 (T3), and 18 weeks (T4) later. Those in the immediate intervention condition will initiate the intervention following the T1 assessment. Those in the wait-list condition will initiate the intervention following the T3 assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
94
The Cellie Coping Kit intervention is grounded in empirical evidence regarding injury recovery. By utilizing parents as coaches, the Cellie Coping intervention can be initiated in the hospital and continued as the child recovers at home. The intervention's portable, engaging design and active partnership with parents as consistently available coaches, allows families to use the intervention anywhere (i.e., home, hospital, during procedures) ensuring the child is supported at the time the injury-related stressor arises. The Cellie Coping Intervention consists of 1) a stuffed toy to promote engagement, 2) caregiver book, and 3) coping cards. Skills are presented in a way usable by most parents and children without medical team support.
University of Kentucky
Lexington, Kentucky, United States
Feasibility of the Cellie Coping Kit Intervention
Feasibility will be primarily assessed via a self-report satisfaction score.
Time frame: 6 weeks
Initial assessment of efficacy of Cellie Intervention on adherence
Compare intervention to wait-list control group on adherence
Time frame: 6 weeks
Initial assessment of efficacy of Cellie Intervention on coping behaviors
Compare intervention to wait-list control group on coping behaviors
Time frame: 6 weeks
Initial assessment of efficacy of Cellie Intervention on physical recovery
Compare intervention to wait-list control group on physical recovery
Time frame: 12 weeks
Initial assessment of efficacy of Cellie Intervention on HRQOL
Compare intervention to wait-list control group on HRQOL
Time frame: 12 weeks
Initial assessment of efficacy of Cellie Intervention on emotional health
Compare intervention to wait-list control group on emotional health
Time frame: 12 weeks
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