A Parent-Led Intervention to Promote Recovery Following Pediatric Injury: Study Protocol for a Randomized Controlled Trial

Background: Injury is one of the most prevalent potentially emotionally traumatic events that children experience and can lead to persistent impaired physical and emotional health. There is a need for interventions that promote full physical and emotional recovery and that can be easily accessed by all injured children. Based on research evidence regarding post-injury recovery, we created the Cellie Coping Kit for Children with Injury intervention to target key mechanisms of action and refined the intervention based on feedback from children, families, and experts in the field. The Cellie Coping Kit intervention is parent-guided and includes a toy (for engagement), coping cards for children, and a book for parents with evidence-based strategies to promote injury recovery. This pilot research trial aims to provide an initial evaluation of the impact of the Cellie Coping Kit for Children with Injury on proximal targets (coping, appraisals) and later child health outcomes (physical recovery, emotional health, health-related quality of life). Method / Design: Eighty children (aged 8–12 years) and their parents will complete a baseline assessment (T1) and then will be randomly assigned to an immediate intervention group or waitlist group. The Cellie Coping Kit for Injury Intervention will be introduced to the immediate intervention group after the T1 assessment and to the waitlist group following the T3 assessment. Follow-up assessments of physical and emotional health will be completed at 6 weeks (T2), 12 weeks (T3), and 18 weeks (T4). Discussion: This will be one of the first randomized controlled trials to examine an intervention tool intended to promote full recovery after pediatric injury and be primarily implemented by children and parents. Results will provide data on the feasibility of the implementation of the Cellie Coping Intervention for Injury as well as estimations of efficacy. Potential strengths and limitations of this design are discussed. Trial Registration: Clinicaltrials.gov, NCT03153696. Registered on 15 May 2017

A parent-led intervention to promote recovery following pediatric injury: study protocol for a randomized controlled trial

Abstract Background Injury is one of the most prevalent potentially emotionally traumatic events that children experience and can lead to persistent impaired physical and emotional health. There is a need for interventions that promote full physical and emotional recovery and that can be easily accessed by all injured children. Based on research evidence regarding post-injury recovery, we created the Cellie Coping Kit for Children with Injury intervention to target key mechanisms of action and refined the intervention based on feedback from children, families, and experts in the field. The Cellie Coping Kit intervention is parent-guided and includes a toy (for engagement), coping cards for children, and a book for parents with evidence-based strategies to promote injury recovery. This pilot research trial aims to provide an initial evaluation of the impact of the Cellie Coping Kit for Children with Injury on proximal targets (coping, appraisals) and later child health outcomes (physical recovery, emotional health, health-related quality of life). Method / Design Eighty children (aged 8–12 years) and their parents will complete a baseline assessment (T1) and then will be randomly assigned to an immediate intervention group or waitlist group. The Cellie Coping Kit for Injury Intervention will be introduced to the immediate intervention group after the T1 assessment and to the waitlist group following the T3 assessment. Follow-up assessments of physical and emotional health will be completed at 6 weeks (T2), 12 weeks (T3), and 18 weeks (T4). Discussion This will be one of the first randomized controlled trials to examine an intervention tool intended to promote full recovery after pediatric injury and be primarily implemented by children and parents. Results will provide data on the feasibility of the implementation of the Cellie Coping Intervention for Injury as well as estimations of efficacy. Potential strengths and limitations of this design are discussed. Trial registration Clinicaltrials.gov, NCT03153696. Registered on 15 May 2017

Pilot randomized controlled trial of a novel web-based intervention to prevent posttraumatic stress in children following medical events

Objective: To assess feasibility and estimate effect size of a self-directed online intervention designed to prevent persistent posttraumatic stress after acute trauma. Methods: Children aged 8–12 years with a recent acute medical event were randomized to the intervention (N = 36) or a 12-week wait list (N = 36). Posttraumatic stress, health-related quality of life, appraisals, and coping were assessed at baseline, 6, 12, and 18 weeks. Results: Most children used the intervention; half completed it. Medium between-group effect sizes were observed for change in posttraumatic stress severity from baseline to 6 weeks (d = −.68) or 12 weeks (d = −.55). Exploratory analyses suggest greatest impact for at-risk children, and a small effect for intervention initiated after 12 weeks. Analysis of covariance did not indicate statistically significant group differences in 12-week outcomes. Conclusions: This pilot randomized controlled trial provides preliminary evidence that a self-directed online preventive intervention is feasible to deliver, and could have an effect in preventing persistent posttraumatic stress

A new method for assessing content validity in model-based creation and iteration of eHealth interventions

Background: The advent of eHealth interventions to address psychological concerns and health behaviors has created new opportunities, including the ability to optimize the effectiveness of intervention activities and then deliver these activities consistently to a large number of individuals in need. Given that eHealth interventions grounded in a well-delineated theoretical model for change are more likely to be effective and that eHealth interventions can be costly to develop, assuring the match of final intervention content and activities to the underlying model is a key step. We propose to apply the concept of "content validity" as a crucial checkpoint to evaluate the extent to which proposed intervention activities in an eHealth intervention program are valid (eg, relevant and likely to be effective) for the specific mechanism of change that each is intended to target and the intended target population for the intervention. Objective: The aims of this paper are to define content validity as it applies to model-based eHealth intervention development, to present a feasible method for assessing content validity in this context, and to describe the implementation of this new method during the development of a Web-based intervention for children. Methods: We designed a practical 5-step method for assessing content validity in eHealth interventions that includes defining key intervention targets, delineating intervention activity-target pairings, identifying experts and using a survey tool to gather expert ratings of the relevance of each activity to its intended target, its likely effectiveness in achieving the intended target, and its appropriateness with a specific intended audience, and then using quantitative and qualitative results to identify intervention activities that may need modification. We applied this method during our development of the Coping Coach Web-based intervention for school-age children. Results: In the evaluation of Coping Coach content validity, 15 experts from five countries rated each of 15 intervention activity-target pairings. Based on quantitative indices, content validity was excellent for relevance and good for likely effectiveness and age-appropriateness. Two intervention activities had item-level indicators that suggested the need for further review and potential revision by the development team. Conclusions: This project demonstrated that assessment of content validity can be straightforward and feasible to implement and that results of this assessment provide useful information for ongoing development and iterations of new eHealth interventions, complementing other sources of information (eg, user feedback, effectiveness evaluations). This approach can be utilized at one or more points during the development process to guide ongoing optimization of eHealth interventions

Systematic, theoretically-grounded development and feasibility testing of an innovative, preventive web-based game for children exposed to acute trauma.

Millions of children are affected by acute medical events annually, creating a need for resources to promote recovery. Although web-based interventions promise wide reach and low cost for users, development can be time- and cost-intensive. A systematic approach to intervention development can help to minimize costs and increase the likelihood of effectiveness. Using a systematic approach, our team integrated evidence on the etiology of traumatic stress, an explicit program theory, and a user-centered design process to intervention development. This study describes evidence and the program theory model applied to the Coping Coach intervention and presents pilot data evaluating intervention feasibility and acceptability. Informed by empirical evidence on traumatic stress prevention, an overarching program theory model was articulated to delineate pathways from specific intervention content to program targets and proximal outcomes to key longer-term health outcomes. Systematic user-testing with children ages 8–12 years (N = 42) exposed to an acute medical event and their parents was conducted throughout intervention development. Functionality challenges in early prototypes necessitated revisions. Child engagement was positive throughout revisions to the Coping Coach intervention. Final pilot-testing demonstrated promising feasibility and high user-engagement and satisfaction. In conclusion, applying a systematic approach to the development of Coping Coach led to the creation of a functional intervention that is accepted by children and parents. Development of new e-health interventions may benefit from a similar approach. Future research should evaluate the efficacy of Coping Coach in achieving targeted outcomes of reduced trauma symptoms and improved health-related quality of life

Acute stress symptoms in children: results from an international data archive

OBJECTIVE: To describe the prevalence of acute stress disorder (ASD) symptoms and to examine proposed DSM-5 symptom criteria in relation to concurrent functional impairment in children and adolescents. METHOD: From an international archive, datasets were identified that included assessment of acute traumatic stress reactions and concurrent impairment in children and adolescents 5 to 17 years of age. Data came from 15 studies conducted in the United States, United Kingdom, Australia, and Switzerland and included 1,645 children and adolescents. Dichotomized items were created to indicate the presence or absence of each of the 14 proposed ASD symptoms and functional impairment. The performance of a proposed diagnostic criterion (number of ASD symptoms required) was examined as a predictor of concurrent impairment. RESULTS: Each ASD symptom was endorsed by 14% to 51% of children and adolescents; 41% reported clinically relevant impairment. Children and adolescents reported from 0 to 13 symptoms (mean = 3.6). Individual ASD symptoms were associated with greater likelihood of functional impairment. The DSM-5 proposed eight-symptom requirement was met by 202 individuals (12.3%) and had low sensitivity (0.25) in predicting concurrent clinically relevant impairment. Requiring fewer symptoms (three to four) greatly improved sensitivity while maintaining moderate specificity. CONCLUSIONS: This group of symptoms appears to capture aspects of traumatic stress reactions that can create distress and interfere with children's and adolescents' ability to function in the acute post-trauma phase. Results provide a benchmark for comparison with adult samples; a smaller proportion of children and adolescents met the eight-symptom criterion than reported for adults. Symptom requirements for the ASD diagnosis may need to be lowered to optimally identify children and adolescents whose acute distress warrants clinical attention