Initial Evaluation of the Cellie Coping Kit for Children With Injury
Condition: Injuries
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Cellie Coping Kit Intervention
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention