Clinical trial NCT03153696: 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
Overall status: COMPLETED
Phase: NA
Conditions: Injuries
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2017-05-15
Enrollment: 94
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Feasibility of the Cellie Coping Kit Intervention
timeFrame: 6 weeks
Secondary outcomes:
measure: Initial assessment of efficacy of Cellie Intervention on adherence
timeFrame: 6 weeks
measure: Initial assessment of efficacy of Cellie Intervention on coping behaviors
timeFrame: 6 weeks
measure: Initial assessment of efficacy of Cellie Intervention on physical recovery
timeFrame: 12 weeks
measure: Initial assessment of efficacy of Cellie Intervention on HRQOL
timeFrame: 12 weeks
measure: Initial assessment of efficacy of Cellie Intervention on emotional health
timeFrame: 12 weeks
Other outcomes:
measure: Examine intervention timing effects
timeFrame: 18 weeks
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Meghan Marsac, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.