The Cellie Coping Kit for children with Eosinophilic Esophagitis: Feasibility, acceptability, and preliminary outcomes.

Children with eosinophilic esophagitis (EoE) are faced with ongoing treatments that can impact their wellbeing. There are no evidence-based resources that families can implement independently to cope with EoE-related stressors. This study aimed to examine acceptability, feasibility, and preliminary outcomes of the newly developed Cellie Coping Kit for Children with EoE intervention. Forty child-caregiver dyads completed a baseline assessment (T1) and initiated the intervention; 30 (75%) child participants and 33 (82.5%) caregivers were retained to follow-up (T2). Of those who completed the T2 assessment, most reported that the intervention was easy to use (>90%) and would recommend the intervention to others (>90%). The intervention was feasible: >70% used the kit, and most indicated they would use it again (>75%). More than half of families reported learning new information and/or coping strategies. No statistically significant changes were identified in comparing T1 and T2 coping and health-related quality of life. These findings suggest that the Cellie Coping Kit for Children with EoE is a promising intervention in that it was well accepted, feasible, and helped many families learn novel strategies on how to manage EoE challenges. Future research should examine how to strengthen the intervention to achieve longer-term targeted outcomes.

Posttraumatic Stress in Children After Injury: The Role of Acute Pain and Opioid Medication Use.

OBJECTIVES: After injury, many children experience posttraumatic stress symptoms (PTSS) that negatively impact recovery. Acute pain and PTSS share neurobiological pathways, and acute dosage of morphine has been linked to reduced PTSS in naturalistic studies. However, the complex interactions between pain, morphine and other opioid use, and PTSS have yet to be investigated in robust pediatric samples.This prospective, longitudinal study examined relationships between acute pain, opioid medications, and PTSS after pediatric injury. METHODS: Ninety-six children aged 8 to 13 years (mean = 10.60, SD = 1.71), hospitalized for unintentional injury, completed assessments at baseline (T1) and 12 weeks (T2) later. Pain ratings and opioid administration data were obtained via chart review. RESULTS: Structural equation modeling revealed that worst pain endorsed during hospitalization was positively associated with concurrent and later PTSS when controlling for evidence-based risk factors (ie, age, sex, prior trauma history, traumatic appraisals of injury event, heart rate). Neither opioid medications overall nor morphine specifically (milligram/kilogram/day) administered during hospitalization mediated the relationship between pain and T2 PTSS. CONCLUSIONS: Pain during hospitalization may increase susceptibility for persistent PTSS above and beyond the influence of other empirical risk factors. Findings suggest that pain assessment may be a useful addition to pediatric PTSS screening tools and highlight the need for additional research on pharmacological secondary prevention approaches. Given that inadequate pain control and persistent PTSS each hinder recovery and long-term functioning, better understanding of interactions between acute pain and PTSS after injury is essential for improving screening, prevention, and early intervention efforts.

Evaluating the Acceptability and Validity of Assessing Pain and Posttraumatic Stress Symptoms in an Adaptable eHealth System for School-Age Children.

OBJECTIVE: To provide initial evaluation of the acceptability of a new eHealth system incorporating personalized self-report assessment of multiple health domains in school age children, and assess convergent validity of two brief measures presented via this system. METHODS: Ill or injured children (N=167) age 6 to 14 recruited in two pediatric health care systems used the prototype eScreen interface on a mobile device to select an avatar and complete brief assessments of pain and posttraumatic stress symptoms (PTSS). Children rated technology acceptability and completed validated measures for pain and PTSS. RESULTS: Children's ratings indicated they found the eScreen interface easy to use (mean rating 4.4 on a 1-5 scale), potentially useful in helping them recover (mean=3.7), and would use / recommend it (mean=4.0). Among children age 6 to 8, mean ratings were: easy to use (3.7), usefulness (3.3), would use/recommend (3.4). Acceptability was largely consistent across child gender, family income, or usual access to mobile devices. eScreen measures showed strong convergent validity with established measures. The eScreen Pain Screener was highly correlated (r =.86 - .92) with, and evidenced strong agreement with, two validated pain measures. eScreen PTSS scores were strongly correlated with a validated PTSS measure (r=.67); a positive PTSS screen was associated with significantly higher PTSS severity. CONCLUSIONS: Study results support the acceptability (ease of use, intention to use/recommend, perceived usefulness) of these tools for older school age children, and provide strong initial evidence for the validity of two brief measures presented in a novel digital modality.

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.

Application of a Framework to Implement Trauma-Informed Care Throughout a Pediatric Health Care Network.

INTRODUCTION: To evaluate the initial application of a recently published three-step framework for implementing trauma-informed care (TIC) in a pediatric health care network by applying Framework for Spread. METHODS: In steps 1 and 2 of the framework, we established commitment from the health care network leadership and initial interest in TIC among clinical providers (step 1), set evidence-based training goals and created the associated TIC training content (step 2). In step 3, 440 health care professionals (from 27 health care teams) participated in single-session, 1-hour training that covered the psychological impact of injury- and illness-related trauma, identification of traumatic stress symptoms, and how to respond to children exposed to potentially traumatic events. A concomitant quality improvement project allowed us to assess potential changes in training participants' favorable attitudes toward the integration of TIC and confidence in delivering TIC. RESULTS: Compared with pretraining, participants demonstrated increases in attitude toward TIC, t(293) = 5.8, P < .001, Cohen's d = 0.32, and confidence in delivering TIC, t(293) = 20.9, P < .001, Cohen's d = 1.09. DISCUSSION: Trainings were effective in achieving proximal goals targeting attitudes and confidence, thereby demonstrating the feasibility and clinical relevance of TIC training when implemented according to the three-step framework. Future research should examine methods of training to reach wide audiences to promote systematic change and evaluate changes in patient outcomes associated with providers' implementation of TIC.

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.

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

BACKGROUND: Millions of children are affected by acute medical events annually, creating need for resources to promote recovery. While 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 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. OBJECTIVE: To describe evidence and the program theory model applied to the Coping Coach intervention and present pilot data evaluating intervention feasibility and acceptability. METHOD: Informed by empirical evidence on traumatic stress prevention, an overarching program theory model was articulated to delineate pathways from a) specific intervention content to b) program targets and proximal outcomes to c) key longer-term health outcomes. Systematic user-testing with children ages 8-12 (N = 42) exposed to an acute medical event and their parents was conducted throughout intervention development. RESULTS: 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. 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.

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.

Preventing posttraumatic stress following pediatric injury: a randomized controlled trial of a web-based psycho-educational intervention for parents.

OBJECTIVE: The study objective is to evaluate the feasibility and efficacy of a web-based intervention for parents (AfterTheInjury.org [ATI]) in promoting emotional recovery following pediatric injury. METHODS: 100 children with injuries requiring medical attention and their parents were randomly assigned to the intervention or usual care. Efficacy outcomes included parent knowledge and child and parent posttraumatic stress symptoms (PTSS). RESULTS: All parents in the intervention group completed the intervention (directed use of ATI) in the hospital. 56% reported using ATI online post-discharge, and 100% of these parents found it helpful. Parent knowledge increased immediately post-intervention, but there was no significant intervention impact on parent knowledge or PTSS at a 6-week follow-up. Relationships between knowledge and PTSS were identified. CONCLUSIONS: Brief web-based interventions introduced during child hospitalization are a feasible strategy to reach many parents following pediatric injury. Preventing psychological symptoms may require more than parental education alone.

Using a web-based game to prevent posttraumatic stress in children following medical events: design of a randomized controlled trial.

BACKGROUND: Medical events including acute illness and injury are among the most common potentially traumatic experiences for children. Despite the scope of the problem, only limited resources are available for prevention of posttraumatic stress symptoms (PTSS) after pediatric medical events. Web-based programs provide a low-cost, accessible means to reach a wide range of families and show promise in related areas of child mental health. OBJECTIVES: To describe the design of a randomized controlled trial that will evaluate feasibility and estimate preliminary efficacy of Coping Coach, a web-based preventive intervention to prevent or reduce PTSS after acute pediatric medical events. METHOD: Seventy children and their parents will be randomly assigned to either an intervention or a waitlist control condition. Inclusion criteria require that children are aged 8-12 years, have experienced a medical event, have access to Internet and telephone, and have sufficient competency in the English language to complete measures and understand the intervention. Participants will complete baseline measures and will then be randomized to the intervention or waitlist control condition. Children in the intervention condition will complete module 1 (Feelings Identification) in the hospital and will be instructed on how to complete modules 2 (Appraisals) and 3 (Avoidance) online. Follow-up assessments will be conducted via telephone at 6, 12, and 18 weeks after the baseline assessment. Following the 12-week assessment, children in the waitlist control condition will receive instructions for completing the intervention. RESULTS: Primary study outcomes include data on intervention feasibility and outcomes (child appraisals, coping, PTSS and health-related quality of life). DISCUSSION: Results will provide data on the feasibility of the implementation of the Coping Coach intervention and study procedures as well as estimations of efficacy to determine sample size for a larger study. Potential strengths and limitations of this design are discussed.

Development and psychometric evaluation of child acute stress measures in Spanish and English.

Clinicians and researchers need tools for accurate early assessment of children's acute stress reactions and acute stress disorder (ASD). There is a particular need for independently validated Spanish-language measures. The current study reports on 2 measures of child acute stress (a self-report checklist and a semistructured interview), describing the development of the Spanish version of each measure and psychometric evaluation of both the Spanish and English versions. Children between the ages of 8 to 17 years who had experienced a recent traumatic event completed study measures in Spanish (n = 225) or in English (n = 254). Results provide support for reliability (internal consistency of the measures in both languages ranged from .83 to .89; cross-language reliability of the checklist was .93) and for convergent validity (with later PTSD symptoms, and with concurrent anxiety symptoms). Comparing checklist and interview results revealed a strong association between severity scores within the Spanish and English samples. Differences between the checklist and interview in evaluating the presence of ASD appear to be linked to different content coverage for dissociation symptoms. Future studies should further assess the impact of differing assessment modes, content coverage, and the use of these measures in children with diverse types of acute trauma exposure in English- and Spanish-speaking children.

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.

Acceptability and feasibility of family use of The Cellie Cancer Coping Kit.

PURPOSE: This study aims to examine the acceptability and feasibility of child and parent use of The Cellie Cancer Coping Kit (Cellie Kit). The Cellie kit is designed to promote coping and decrease distress in children undergoing pediatric cancer treatment. It includes a plush toy, coping cards, and book for caregivers. METHODS: In study 1, 15 children (ages 6-12) undergoing cancer treatment and their parents reviewed the Cellie Kit materials and provided feedback on its acceptability and perceived feasibility of use. In study 2, 15 additional children (ages 6-12) and their parents participated in a pilot intervention of the Cellie Kit and completed follow-up interviews and a satisfaction measure. RESULTS: In study 1, all parents reported that they could understand the book and enact its coping tips and that the Cellie Kit was relevant to their families' cancer experience. Children explained they would use the Cellie Kit for emotional expression, fun, and comfort. The Cellie Kit was revised after study 1 to integrate additional material suggested by families. In study 2, all families completing follow-up assessments reported utilizing the Cellie Kit. A majority (86 % of children and 100 % of parents) indicated that they would recommend the Cellie Kit to others, and most (64 % of children and 93 % of parents) reported learning new information and/or skills from the Cellie Kit. CONCLUSIONS: The Cellie Kit is an engaging, helpful, and easy-to-use coping tool for families facing pediatric cancer treatment. Future research should examine the efficacy of brief interventions using the Cellie Kit to promote adjustment to pediatric cancer.

A pilot randomized controlled trial assessing secondary prevention of traumatic stress integrated into pediatric trauma care.

Medical settings provide opportunities for secondary prevention of traumatic stress and other sequelae of pediatric injury. This pilot randomized trial evaluated the delivery and effectiveness of a targeted preventive intervention based on best practice recommendations and integrated within acute medical care. Hospitalized injured children were screened for risk of developing posttraumatic stress disorder (PTSD). Those at risk (N = 85) were randomized to the intervention (n = 46) or usual care (n = 39). The preventive intervention did not reduce PTSD or depression severity or increase health-related quality of life, compared to usual care. Both groups improved over time, but 6 months postinjury approximately 10% of each group still met criteria for PTSD, suggesting room for improvement in comprehensive pediatric injury care.

Child coping and parent coping assistance during the peritrauma period in injured children.

Pediatric physical injury is a very common, potentially traumatic medical event that many families face each year. The role that child or parent coping behavior plays in emotional recovery from injury is not well understood. This study described coping used by children and coping assistance implemented by parents in the early aftermath of a child's injury. Ten child-parent dyads participated in individual semistructured interviews that were audiorecorded, transcribed, and coded using hierarchical coding schemes. Study findings highlight reliance on a broad range of coping strategies. Although children and parents report some similarities in their perceptions of child coping, parents do not recognize all the coping strategies that children report. This suggests potential for improvement in parent-child communication concerning coping techniques. Parents report a limited number of coping assistance strategies, indicating a niche for preventive programs. Further research should examine coping during the peritrauma period as it relates to physical and emotional outcomes to inform secondary prevention programs.