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Initial Evaluation of the Cellie Coping Kit for Children With Injury

Primary Purpose

Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cellie Coping Kit Intervention
Sponsored by
Meghan Marsac
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Injuries

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Cellie Intervention

Cellie Wait-list Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Feasibility of the Cellie Coping Kit Intervention
Feasibility will be primarily assessed via a self-report satisfaction score.

Secondary Outcome Measures

Initial assessment of efficacy of Cellie Intervention on adherence
Compare intervention to wait-list control group on adherence
Initial assessment of efficacy of Cellie Intervention on coping behaviors
Compare intervention to wait-list control group on coping behaviors
Initial assessment of efficacy of Cellie Intervention on physical recovery
Compare intervention to wait-list control group on physical recovery
Initial assessment of efficacy of Cellie Intervention on HRQOL
Compare intervention to wait-list control group on HRQOL
Initial assessment of efficacy of Cellie Intervention on emotional health
Compare intervention to wait-list control group on emotional health

Full Information

First Posted
May 2, 2017
Last Updated
February 13, 2020
Sponsor
Meghan Marsac
Collaborators
Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT03153696
Brief Title
Initial Evaluation of the Cellie Coping Kit for Children With Injury
Official Title
Application of Theory and Evidence to Promote Full Recovery From Pediatric Injury
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 2, 2019 (Actual)
Study Completion Date
December 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Meghan Marsac
Collaborators
Children's Hospital of Philadelphia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injuries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cellie Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Cellie Wait-list Control
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cellie Coping Kit Intervention
Intervention Description
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 Outcome Measure Information:
Title
Feasibility of the Cellie Coping Kit Intervention
Description
Feasibility will be primarily assessed via a self-report satisfaction score.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Initial assessment of efficacy of Cellie Intervention on adherence
Description
Compare intervention to wait-list control group on adherence
Time Frame
6 weeks
Title
Initial assessment of efficacy of Cellie Intervention on coping behaviors
Description
Compare intervention to wait-list control group on coping behaviors
Time Frame
6 weeks
Title
Initial assessment of efficacy of Cellie Intervention on physical recovery
Description
Compare intervention to wait-list control group on physical recovery
Time Frame
12 weeks
Title
Initial assessment of efficacy of Cellie Intervention on HRQOL
Description
Compare intervention to wait-list control group on HRQOL
Time Frame
12 weeks
Title
Initial assessment of efficacy of Cellie Intervention on emotional health
Description
Compare intervention to wait-list control group on emotional health
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Examine intervention timing effects
Description
Examine differences in 12 week and 18 week outcomes on mechanisms of action and targeted health outcomes
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meghan Marsac, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30777113
Citation
Marsac ML, Sprang G, Guller L, Kohser KL, Draus JM Jr, Kassam-Adams N. A parent-led intervention to promote recovery following pediatric injury: study protocol for a randomized controlled trial. Trials. 2019 Feb 18;20(1):137. doi: 10.1186/s13063-019-3207-9.
Results Reference
derived

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Initial Evaluation of the Cellie Coping Kit for Children With Injury

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