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Completed

NCT Number: NCT03153696

Initial Evaluation of the Cellie Coping Kit for Children With Injury

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).

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Key information

Conditions

Injuries Wounds and Injuries

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40502, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cellie Coping Kit Intervention

Behavioral

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.

Primary outcomes

  1. Feasibility of the Cellie Coping Kit Intervention

    Time frame: 6 weeks

    Feasibility will be primarily assessed via a self-report satisfaction score.

Secondary outcomes

  1. Initial assessment of efficacy of Cellie Intervention on adherence

    Time frame: 6 weeks

    Compare intervention to wait-list control group on adherence

  2. Initial assessment of efficacy of Cellie Intervention on coping behaviors

    Time frame: 6 weeks

    Compare intervention to wait-list control group on coping behaviors

  3. Initial assessment of efficacy of Cellie Intervention on physical recovery

    Time frame: 12 weeks

    Compare intervention to wait-list control group on physical recovery

  4. Initial assessment of efficacy of Cellie Intervention on HRQOL

    Time frame: 12 weeks

    Compare intervention to wait-list control group on HRQOL

  5. Initial assessment of efficacy of Cellie Intervention on emotional health

    Time frame: 12 weeks

    Compare intervention to wait-list control group on emotional health

Other outcomes

  1. Examine intervention timing effects

    Time frame: 18 weeks

    Examine differences in 12 week and 18 week outcomes on mechanisms of action and targeted health outcomes

Sponsors and collaborators

Lead sponsor

Meghan Marsac

Other

Collaborators

  • Children's Hospital of Philadelphia

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 15, 2017
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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