Initial Evaluation of the Cellie Coping Kit for Children With Injury

NCT ID: NCT03153696

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-12-02

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.

Conditions

Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cellie Coping Kit Intervention

Intervention Type: 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 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.

Group Type: OTHER

Cellie Coping Kit Intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: collaborator

Meghan Marsac

OTHER

Sponsor Role: lead

Responsible Party

Meghan Marsac

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Meghan Marsac, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30777113 (View on PubMed)

Other Identifiers

17-0187-P1G

Identifier Type: -

Identifier Source: org_study_id