Initial Evaluation of the Cellie Coping Kit for Children With Injury

February 13, 2020 updated by: Meghan Marsac

Application of Theory and Evidence to Promote Full Recovery From Pediatric 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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40502
        • University Of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Cellie Intervention
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
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.
OTHER: Cellie Wait-list Control
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of the Cellie Coping Kit Intervention
Time Frame: 6 weeks
Feasibility will be primarily assessed via a self-report satisfaction score.
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Initial assessment of efficacy of Cellie Intervention on adherence
Time Frame: 6 weeks
Compare intervention to wait-list control group on adherence
6 weeks
Initial assessment of efficacy of Cellie Intervention on coping behaviors
Time Frame: 6 weeks
Compare intervention to wait-list control group on coping behaviors
6 weeks
Initial assessment of efficacy of Cellie Intervention on physical recovery
Time Frame: 12 weeks
Compare intervention to wait-list control group on physical recovery
12 weeks
Initial assessment of efficacy of Cellie Intervention on HRQOL
Time Frame: 12 weeks
Compare intervention to wait-list control group on HRQOL
12 weeks
Initial assessment of efficacy of Cellie Intervention on emotional health
Time Frame: 12 weeks
Compare intervention to wait-list control group on emotional health
12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Meghan Marsac

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Children's Hospital of Philadelphia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Meghan Marsac, PhD, University Of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 2, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 2, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-0187-P1G

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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