Initial Evaluation of the Cellie Coping Kit for Children With Injury

Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03153696
• Other study ID #: 17-0187-P1G
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 2, 2019

Study information

• Verified date: February 2020
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 2, 2019
• Est. primary completion date: December 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Meghan Marsac	Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Examine intervention timing effects	Examine differences in 12 week and 18 week outcomes on mechanisms of action and targeted health outcomes	18 weeks
Primary	Feasibility of the Cellie Coping Kit Intervention	Feasibility will be primarily assessed via a self-report satisfaction score.	6 weeks
Secondary	Initial assessment of efficacy of Cellie Intervention on adherence	Compare intervention to wait-list control group on adherence	6 weeks
Secondary	Initial assessment of efficacy of Cellie Intervention on coping behaviors	Compare intervention to wait-list control group on coping behaviors	6 weeks
Secondary	Initial assessment of efficacy of Cellie Intervention on physical recovery	Compare intervention to wait-list control group on physical recovery	12 weeks
Secondary	Initial assessment of efficacy of Cellie Intervention on HRQOL	Compare intervention to wait-list control group on HRQOL	12 weeks
Secondary	Initial assessment of efficacy of Cellie Intervention on emotional health	Compare intervention to wait-list control group on emotional health	12 weeks