Initial Evaluation of the Cellie Coping Kit for Children With Injury

NCT03153696 | Completed

• 1 other identifier: 17-0187-P1G
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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).

Conditions

Injuries

Outcome Measures

Primary Outcomes (1)

• Feasibility of the Cellie Coping Kit Intervention

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

  6 weeks

Secondary Outcomes (5)

• Initial assessment of efficacy of Cellie Intervention on adherence

  6 weeks

• Initial assessment of efficacy of Cellie Intervention on coping behaviors

  6 weeks

• Initial assessment of efficacy of Cellie Intervention on physical recovery

  12 weeks

• Initial assessment of efficacy of Cellie Intervention on HRQOL

  12 weeks

• Initial assessment of efficacy of Cellie Intervention on emotional health

  12 weeks

Other Outcomes (1)

• Examine intervention timing effects

  18 weeks

Study Arms (2)

Cellie Intervention

EXPERIMENTAL

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

Cellie Wait-list Control

OTHER

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

Interventions

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.

Cellie Intervention; Cellie Wait-list Control

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• injury resulting from family violence

Sponsors & Collaborators

• Meghan Marsac: lead
• Children's Hospital of Philadelphia: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40502, United States

Location

Related Publications (1)

• 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.

  PMID: 30777113 DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Meghan Marsac, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 15, 2017
• Study Start: August 1, 2017
• Primary Completion: December 2, 2019
• Study Completion: December 2, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)