Initial Evaluation of the Cellie Coping Kit for Children With Injury
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 8 - 12 |
| Updated: | 9/20/2018 |
| Start Date: | August 1, 2017 |
| End Date: | June 1, 2020 |
| Contact: | Meghan Marsac, PhD |
| Email: | meghan.marsac@uky.edu |
| Phone: | 8593233850 |
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).
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).
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.
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.
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
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