Initial Evaluation of the Cellie Coping Kit for Children With Injury

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Application of Theory and Evidence to Promote Full Recovery From Pediatric Injury

Conditions
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Injuries

Intervention / Treatment
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* Behavioral: Cellie Coping Kit Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: child has incurred an injury within the last month requiring medical attention one caregiver per child willing to participate sufficient English language skills to understand intervention and assessment materials access to internet or telephone for follow-up assessments Exclusion Criteria: injury resulting from family violence

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cellie Intervention<br>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. In this condition, children and parents will be introduced to the Cellie Intervention immediately following the completion of the T1 measures. | Behavioral: Cellie Coping Kit Intervention<br>* 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.<br>|
| Other: Cellie Wait-list Control<br>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. In this condition, children and parents will be introduced to the Cellie Intervention via phone and mail following the completion of the T3 measures. | Behavioral: Cellie Coping Kit Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the Cellie Coping Kit Intervention | Feasibility will be primarily assessed via a self-report satisfaction score. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial assessment of efficacy of Cellie Intervention on adherence | Compare intervention to wait-list control group on adherence | 6 weeks | 
| Initial assessment of efficacy of Cellie Intervention on coping behaviors | Compare intervention to wait-list control group on coping behaviors | 6 weeks | 
| Initial assessment of efficacy of Cellie Intervention on physical recovery | Compare intervention to wait-list control group on physical recovery | 12 weeks | 
| Initial assessment of efficacy of Cellie Intervention on HRQOL | Compare intervention to wait-list control group on HRQOL | 12 weeks | 
| Initial assessment of efficacy of Cellie Intervention on emotional health | Compare intervention to wait-list control group on emotional health | 12 weeks |