User-Centered Development of HEARTPrep, a Digital Health Psychosocial Intervention for Prenatally Diagnosed Congenital Heart Disease.

User-centered models for the development of digital health interventions are not consistently applied in healthcare settings. This study used a five-phase, user-centered approach to develop HEARTPrep©, a psychosocial intervention delivered via mobile app and telehealth to mothers expecting a baby with congenital heart disease (CHD) to promote maternal, family, and child well-being. Phases of intervention development were: (I) establishing partnerships; (II) creating content; (III) developing prototype and testable intervention; (IV) conducting think-aloud testing; and (V) completing beta testing. Partnerships with parents, clinicians, and design/technology experts were integral throughout the development of HEARTPrep©. Parents of children with CHD also served as participants in Phases II-V, contributing to the creation of content and providing feedback to inform the iterative refinement of HEARTPrep©. These five phases produced a refined digital health intervention with promising feasibility, usability, and acceptability results. This user-centered approach can be used to develop digital health interventions targeting various health outcomes.

Daytime Sleepiness in Children With Asthma: Examining Respiratory and Non-respiratory Factors.

Objective Daytime sleepiness is common in youth with asthma (YWA). Treatments designed to mitigate daytime sleepiness in YWA require an understanding of the primary causes of this problem. We examined respiratory- and non-respiratory-related factors associated with daytime sleepiness in YWA. Methods One hundred YWA (eight to 17 years old) were included in a cross-sectional study. Daytime sleepiness, quality of life, anxiety, bedtime cellphone use, and respiratory symptoms were self-reported. Asthma severity, lung function, and the number of prescribed medications were obtained from electronic medical records. Multivariable regression models identifying variables associated with daytime sleepiness were generated. Results Participants were 54% male and 45% Black, with a mean age of 12.1 years. The multivariable regression model showed decreased quality of life (b = -0.328, p = 0.004) and increased bedtime cellphone use (b = 0.300, p = 0.004)were significantly related to daytime sleepiness, while anxiety (b = 0.213, p = 0.05), prescribed asthma medications (b = 0.173, p = 0.05), and worse lung function (b = -0.173, p = 0.05)were marginally related to daytime sleepiness. Conclusions In addition to optimizing asthma control, strategies targeting anxiety, quality of life, and nocturnal cellphone use are important to mitigate daytime sleepiness in YWA.

The Electronic Surviving Cancer Competently Intervention Program-a Psychosocial Digital Health Intervention for English- and Spanish-Speaking Parents of Children With Cancer: Protocol for Randomized Controlled Trial.

BACKGROUND: The psychosocial needs and risks of children with cancer and their families are well-documented including increased risk of parental distress, posttraumatic stress, and anxiety. There is a critical need to provide evidence-based psychosocial care to parents and caregivers of children with cancer. Digital health interventions are important to address many barriers to in-person intervention delivery but are not widely used in pediatric psychosocial cancer care. The COVID-19 pandemic has reinforced the need for flexible, acceptable, and accessible psychosocial digital health interventions. The Electronic Surviving Cancer Competently Intervention Program (eSCCIP) is an innovative digital health intervention for parents and caregivers of children with cancer, delivered through a combination of self-guided web-based content and supplemented by 3 telehealth follow-up sessions with a trained telehealth guide. A Spanish language adaptation of eSCCIP, El Programa Electronico de Intervencion para Superar Cancer Competentemente (eSCCIP-SP), has been developed. The self-guided web-based cores of eSCCIP/eSCCIP-SP are a mix of didactic video content, multifamily video discussion groups featuring parents of children with cancer, and hands-on web-based activities. OBJECTIVE: The objective of this study is to test eSCCIP/eSCCIP-SP in a multisite randomized controlled trial, compared to an internet-based education control condition consisting of information specifically focused on concerns relevant to parents and caregivers of children with cancer. METHODS: Using a randomized controlled clinical trial design, 350 eligible parents and caregivers of children with cancer will be randomly assigned to the intervention (eSCCIP/eSCCIP-SP) or an education control condition. Data will be collected at 3 time points: preintervention (prior to randomization), immediately post intervention (after 6 weeks), and at a 3-month follow-up (from baseline). Participants randomized to either condition will receive study material (eSCCIP/eSCCIP-SP intervention or education control website) in English or Spanish, based on the primary language spoken in the home and participant preference. RESULTS: The primary study end point is a reduction in acute distress from baseline to postintervention, with secondary end points focused on reductions in symptoms of posttraumatic stress and anxiety, and improvements in coping self-efficacy and cognitive coping. An additional exploratory aim will be focused on implementation strategies and potential costs and cost-savings of eSCCIP/eSCCIP-SP, laying the groundwork for future trials focused on dissemination and implementation, stepped-care models, and intervention refinement. CONCLUSIONS: This trial will provide necessary data to evaluate the efficacy of eSCCIP/eSCCIP-SP. This intervention has the potential to be an easily scalable and highly impactful psychosocial treatment option for parents and caregivers of children with cancer. TRIAL REGISTRATION: ClinicalTrials.gov NCT05294302; https://clinicaltrials.gov/ct2/show/NCT05294302. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/46339.

Virtually Delivered Psychosocial Intervention for Prenatally Diagnosed Congenital Heart Disease: Feasibility and Acceptability of HEARTPrep.

Prenatal diagnosis of congenital heart disease (CHD) often leads to anxiety, depression, and traumatic stress in expectant mothers, with long-term implications for the child and family. However, psychosocial intervention is rarely incorporated into prenatal care. HEARTPrep is a virtually delivered psychosocial intervention aimed at reducing distress and social isolation and increasing parenting self-efficacy and hope for mothers expecting a baby with CHD to promote long-term child/family well-being. This study evaluated the feasibility and acceptability of HEARTPrep. Participants were mothers receiving cardiology care for a fetal CHD diagnosis. Partners could participate with the mother. HEARTPrep was delivered through a mobile app and telehealth. Feasibility was assessed through enrollment/retention rates. Acceptability was assessed through 20 Likert-scale and five open-ended questions. Of 39 recruited mothers, 35 (90%) enrolled. Half of partners (48%) also participated. Twenty-seven of 35 enrolled mothers (77%) completed HEARTPrep. On a scale from 0 (Not at All) to 4 (Very), mean item acceptability scores ranged from 3.5 to 3.9. Mothers reported HEARTPrep helped them feel less distressed (mean: 3.74), less alone (3.84), more prepared (3.89), and more hopeful (3.84). Opportunities to process emotions, develop coping skills, learn with their partner, navigate relationships, understand they are not alone, connect with peer support, access resources, and prepare for stressors were described as helpful. HEARTPrep is feasible and acceptable for mothers expecting a baby with CHD. Future research will evaluate its efficacy in preventing/reducing maternal mental health problems and improving postnatal clinical outcomes.

Pediatric primary care clinicians' views on needs and challenges in caring for infants with intrauterine opioid exposure and their families.

Opioid use disorder (OUD) during pregnancy has risen in the U.S. over the past two decades, resulting in a growing number of children with intrauterine opioid exposure (IOE). Limited research exists supporting best practices to optimize primary care for these children and their families, particularly mothers with OUD. Using a modified Delphi method, we surveyed pediatric primary care clinicians from a single children's health care system regarding their experiences in caring for this population. In Phase 1, open-ended survey questions inquired about needs and challenges facing these infants, their families, and clinicians and resources within primary care. After thematic analysis, the most frequent responses were presented as a Phase 2 survey for clinicians to select their top five. Percentages for the most commonly selected top five themes were tabulated. Survey response rates were 58/139 (42%) for Phase 1 and 45/137 (33%) for Phase 2. For infants with IOE and their families, respondents identified parenting knowledge and family issues related to maternal OUD as top challenges, with limited resources to address them in primary care. Clinicians identified time constraints and follow-up issues as top challenges. Future intervention in pediatric primary care could include addressing parenting education, resource gaps, and best practice recommendations in caring for children with IOE.

Acceptability and Feasibility of eSCCIP: Results From a Pilot Study of the Electronic Surviving Cancer Competently Intervention Program.

BACKGROUND: Providing high-quality psychosocial care to parents and other primary caregivers of children with cancer (henceforth referred to as caregivers) is important, given the numerous challenges associated with a pediatric cancer diagnosis and the increased risk for negative psychosocial sequelae among caregivers. The Electronic Surviving Cancer Competently Intervention Program (eSCCIP) is a psychosocial eHealth intervention for caregivers, developed using an iterative, user-centered process. METHOD: eSCCIP was tested in a single-arm pilot trial at Nemours Children's Hospital, Delaware (NCT05333601). The primary outcomes were intervention acceptability and feasibility, assessed via enrollment and retention targets, and item-level acceptability ratings. Enrollment and retention targets of 45% were set based on previous work, and an item-level acceptability threshold of 80% was set. A secondary exploratory analysis was conducted examining acute distress, anxiety, symptoms of post-traumatic stress, and family functioning. RESULTS: 44 caregivers enrolled in the study and 31 completed. The intervention was rated favorably by completers, with over 80% of the sample selecting "mostly true" or "very true" for all items of the eSCCIP Evaluation Questionnaire, which was used to assess acceptability and feasibility. Enrollment and retention rates were 54% and 70%, respectively. Exploratory psychosocial outcomes showed statistically significant decreases from pre-intervention to post-intervention for overall symptoms of post-traumatic stress disorder (PTSD), cluster D symptoms of PTSD (negative mood and cognitions), and anxiety. Small-moderate effect sizes were observed for all psychosocial outcomes of interest. CONCLUSIONS: eSCCIP is an acceptable and feasible intervention for caregivers. Results are promising regarding reductions in symptoms of post-traumatic stress and anxiety.

Acceptability and feasibility of a brief behavioral sleep intervention for youth with CF.

Youth with CF are at increased risk for physiological and behavioral sleep difficulties due to disease-specific symptoms and more general pediatric sleep challenges. Despite evidence suggesting that behavioral sleep interventions are effective for improving common sleep difficulties, no interventions exist for youth with CF. SLEEP-CF was designed to fill this gap by providing tailored, flexible behavioral sleep support to youth with CF. Results suggest that SLEEP-CF is an acceptable and feasible behavioral sleep intervention, even in a population with normative sleep habits. There may be benefit in terms of improving sleep knowledge and sleep hygiene. Technology use during and after bedtime is prevalent. CF care team members are encouraged to assess sleep as part of routine CF care, and to provide support as indicated.

Dyadic digital health interventions: Their rationale and implementation.

While most psychosocial and behavioral digital health interventions have been designed to be consumed by an individual, intervening at the level of a dyad - two interdependent individuals - can more comprehensively address the needs of both individuals and their relationship. The clinical utility of the dyadic digital health intervention approach, as well as the practical implementation of this design, will be demonstrated via three examples: eSCCIP, FAMS, and OurRelationship.

COVID-19 Exposure and Family Impact Scales for Adolescents and Young Adults.

OBJECTIVE: To understand the impact of the coronavirus disease 2019 (COVID-19) pandemic on adolescents and young adults (AYAs), we adapted the COVID-19 Exposure and Family Impact Scales (CEFIS; Kazak et al., 2021) for AYAs. Here, we report on the development, structure, and psychometric properties of the CEFIS-AYA. METHODS: The CEFIS-AYA was developed by a multidisciplinary, multi-institutional team using a rapid iterative process. Data from 3,912 AYAs from 21 programs at 16 institutions across the United States were collected from May 2020 to April 2021. We examined the underlying structure of the CEFIS-AYA using principal component analysis (PCA), calculated internal consistencies, and explored differences in scores by gender and age. RESULTS: Participants reported exposure to a range of COVID-19-related events (M = 9.08 events, of 28). On the bidirectional 4-point Impact scale, mean item scores were mostly above the midpoint, indicating a slightly negative impact. Kuder-Richardson 20/Cronbach's Alpha was good for Exposure (α = .76) and excellent for Impact (α = .93). PCA identified seven factors for Exposure (Severe COVID-19, Loss of Income, Limited Access to Essentials, COVID-19 Exposure, Disruptions to Activities, Disruptions to Living Conditions, and Designation as an Essential Worker) and five for Impact (Self and Family Relationships, Physical Well-Being, Emotional Well-Being, Social Well-Being, and Distress). Gender and age differences in CEFIS-AYA scores were identified. DISCUSSION: Initial reliability data are strong and support use of the CEFIS-AYA for measuring the effect of the COVID-19 pandemic on AYAs in research and clinical care.

Validation of the COVID-19 Exposure and Family Impact Scales.

OBJECTIVE: The COVID-19 Exposure and Family Impact Scales (CEFIS) were developed in Spring 2020 to assess effects of the COVID-19 pandemic on families and caregivers. Initial psychometric properties were promising. The current study examined the factor structure and evaluated convergent and criterion validity of the CEFIS in a new sample. METHODS: In October and November 2020, caregivers (N = 2,531) of youth (0-21 years) scheduled for an ambulatory care visit at Nemours Children's Hospital, Delaware completed the CEFIS and measures of convergent (PROMIS Global Mental Health Scale, Family Assessment Device) and criterion validity (PTSD Checklist-Civilian). Confirmatory factor analysis was used to examine the factor structure of the CEFIS. Bivariate correlations and logistic regression were used to examine convergent and criterion validity. RESULTS: Factor analysis supported the original six- and three-factor structures for the Exposure and Impact scales, respectively. Second-order factor analyses supported the use of Exposure, Impact, and Distress total scores. Higher scores on the CEFIS Exposure, Impact, and Distress scales were associated with increased mental health concerns and poorer family functioning. Higher scores on all CEFIS scales were also associated with greater odds of having clinically significant posttraumatic stress symptoms. CONCLUSIONS: The CEFIS is a psychometrically sound measure of the impact of the COVID-19 pandemic on family and caregiver functioning and may also be useful in identifying families who would benefit from psychological supports.

A Qualitative Exploration of Sleep Habits and Intervention Needs Among Youth with Cystic Fibrosis.

Evidence suggests that individuals with Cystic Fibrosis (CF) experience difficulties with sleep architecture and hygiene, although research is limited. There are currently no behavioral sleep interventions for youth with CF. The current study used qualitative methods to understand sleep needs and concerns among youth with CF, as well as to obtain feedback about potentially useful behavioral sleep intervention strategies. Semi-structured interviews were conducted with youth with CF between the ages of 11-17 and their parents. Themes were extracted from the data and will be used to inform the development of a brief behavioral sleep intervention for youth with CF. Youth and their parents described several CF-specific sleep concerns, often related to respiratory symptoms, and a number of strategies used to manage these concerns. They also described concerns that apply to the general population, including pervasive use of technology around bedtime. Many evidence-based behavioral sleep intervention strategies are acceptable to youth with CF, although modifications are appropriate to reduce time burden and address CF-specific needs. Youth with CF experience a number of disease-specific and more generalized sleep concerns which are likely amenable to behavioral intervention. Results from this study will be used to inform the development of a brief behavioral sleep intervention for youth with CF.

A community-based trial of a psychosocial eHealth intervention for parents of children with cancer.

BACKGROUND: The Electronic Surviving Cancer Competently Intervention Program (eSCCIP), a psychosocial eHealth intervention for parents and caregivers of children with cancer (parents), was delivered in a community-based psychosocial oncology center. Primary endpoints were intervention acceptability, feasibility, and accessibility, with a secondary exploratory focus on psychosocial outcomes. PROCEDURE: Oncology therapists in a psychosocial oncology center were trained in eSCCIP delivery. Participants were eligible for participation if they were the primary caregiver of a child with cancer between the ages 0 and 17, could read and write in English, and had reliable internet access to complete eSCCIP. Surveys were administered electronically at baseline and post intervention to evaluate study endpoints. Effect sizes (Cohen's d) were computed for exploratory psychosocial outcomes. Nineteen parents completed the intervention. RESULTS: Parents rated eSCCIP as highly acceptable, feasible, and accessible. A large clinical effect was detected for acute distress (d = 0.79). Moderate clinical effects were reported for overall posttraumatic stress disorder (PTSD) symptoms (d = 0.37), negative mood/cognitions (d = 0.59), and symptoms of anxiety (d = 0.48). CONCLUSIONS: Results indicate that eSCCIP is an acceptable, feasible, and accessible psychosocial intervention for parents. Exploratory analyses suggest that participation in eSCCIP may contribute to decreases in acute distress, symptoms of anxiety, and symptoms of PTSD.

COVID-19 Exposure and Family Impact Scales: Factor Structure and Initial Psychometrics.

OBJECTIVE: In response to the rapidly unfolding coronavirus disease 2019 (COVID-19) pandemic in spring 2020, we developed a caregiver-report measure to understand the extent to which children and families were exposed to events related to COVID-19 and their perceptions of its impact. This article reports on the factor structure and psychometric properties of this measure. METHODS: The COVID-19 Exposure and Family Impact Scales (CEFIS) were developed by a multidisciplinary, multi-institutional team using a rapid iterative process. Data from 1805 caregivers recruited from 28 programs at 15 institutions across the United States were collected from May-September 2020. We examined the underlying structure of the CEFIS using exploratory factor analyses and its internal consistency (Cronbach's alpha). RESULTS: Participants reported a range of COVID-19-related events (M = 8.71 events of 25). On the bidirectional 4-point impact scale, mean scores were mostly above the midpoint, indicating a slightly negative impact. Cronbach's alpha was excellent for Exposure (α = .80) and Impact (α = .92). Factor analysis identified six factors for Exposure (COVID-19 experiences, Access to essentials, Disruptions to living conditions, Loss of income, Family caregiving and activities, and Designation as an essential worker). There were three factors for Impact (Personal well-being, Family interactions, and Distress). DISCUSSION: The CEFIS has strong factors assessing Exposure to events related to COVID-19, and the Impact of these events on families of children in pediatric healthcare. These initial validation data support use of the CEFIS for measuring the effect of the pandemic.

The impact of pediatric hematopoietic stem cell transplant timing and psychosocial factors on family and caregiver adjustment.

BACKGROUND: The impact of pediatric hematopoietic stem cell transplant (HCT) on family functioning varies, but little is known about how the timing of HCT in children's treatment course contributes to this variability. This study examines how preexisting child, sibling, and family problems, the length of time between diagnosis to HCT, and children's age at HCT are associated with family and caregiver functioning. PROCEDURE: Caregivers (n = 140) of children (≤18 years old) scheduled to undergo their first HCT completed the Psychological Assessment Tool-HCT and the Impact on Family Scale. Treatment information was extracted from electronic medical records. A bootstrapped multivariate path analysis was used to test the hypotheses. RESULTS: More preexisting family problems related to greater caregiver perceived negative impact of their child's HCT across family and caregiver functioning domains. Less time between diagnosis and HCT was associated with greater caregiver personal strain, particularly for those with younger children undergoing HCT. Younger child age at HCT was also associated with a larger negative impact on family social functioning. CONCLUSIONS: Families with preexisting problems are the most at-risk for experiencing negative impacts related to their child's HCT. The timing of a child's HCT within their treatment course and the child's age during HCT may impact families' social functioning and caregiver adjustment. Screening families for preexisting family problems, particularly for families with young children or who are abruptly learning of their child's need for an HCT, may assist providers in identifying families who would benefit from earlier or more intensive psychosocial support.

Pediatric Psychosocial Standards of Care in action: Research that bridges the gap from need to implementation.

OBJECTIVE: To describe innovative models of psychosocial care delivery that align with published Standards of Psychosocial Care of Children with Cancer and their Families, in efforts to bridge the divide between research and practice. METHODS: The Mattie Miracle Cancer Foundation, in partnership with the American Psychosocial Oncology Society reviewed 22 letters of intent and 13 full grants and awarded small grants to researchers with high quality projects that aimed to implement any of the published 15 Standards of Care. For three of the highest rated funded research projects, we describe the Standard implemented, the novel research design and implementation strategies, and how the research findings might inform the development, implementation, and dissemination of effective solutions for bridging Standard-to-practice gaps. RESULTS: The first study presented is an innovative eHealth intervention for parents of children with cancer designed to improve family functioning and decrease symptoms of acute distress, anxiety, and posttraumatic stress. The second study addresses the acceptability and feasibility of using daily text message assessments of oral chemotherapy adherence in adolescents and young adults with leukemia, and the third creates a blueprint for providing psychosocial services to siblings, including ways to overcome common implementation barriers. CONCLUSIONS: Several themes emerged from the studies presented, including (1) attention to barriers to previous attempts at implementation; (2) technology's role in delivering care; (3) the need for stakeholder involvement; and (4) consideration for multi-pronged solutions that address heterogeneity in care settings. Next steps for integrating the Standards of Psychosocial Care into clinical practice are discussed.

Strategies for Successful Recruitment and Retention of Parents in Pediatric Psychosocial eHealth Interventions: A Qualitative Study in Pediatric Oncology.

OBJECTIVE: Psychosocial intervention studies with parents often have difficulty with regard to participant recruitment, retention, and engagement. Prior to conducting a pilot test of the Electronic Surviving Cancer Competently Intervention Program (eSCCIP), a psychosocial eHealth intervention for parents of children with cancer, a qualitative study was designed to preemptively generate strategies to address potential difficulties in these domains. METHODS: Two focus groups and three semi-structured interviews were conducted with parents of children with cancer. Qualitative data were analyzed using the principles of thematic and content analysis. Themes were generated to describe results and inform the development of concrete recruitment, retention, and engagement strategies to be utilized in future intervention trials. RESULTS: Five themes emerged specific to recruitment, and three themes emerged related to retention and engagement. Parents highlighted a number of important potential recruitment, retention, and engagement strategies, including the importance of flexibility, ease of access and use, intervention timing, and pathways to follow-up care. Themes were linked to actionable recruitment, retention, and engagement strategies which can be utilized in future studies. CONCLUSION: Results from the current study will be utilized when designing future eSCCIP intervention trials and will also be of use to the broader field of psychosocial eHealth intervention research in pediatric psychology. This study also underscores the importance of working with parent stakeholders at all phases of study design and implementation.

A psychosocial clinical care pathway for pediatric hematopoietic stem cell transplantation.

OBJECTIVE: Currently, no evidence-based psychosocial clinical care pathways (PCCP) exist to triage psychosocial risk levels and guide delivery of psychosocial care to youth receiving a hematopoietic stem cell transplantation (HCT) and their families. The purpose of this paper is to describe the use of qualitative research methodologies to develop PCCP in pediatric HCT consistent with the Standards for Psychosocial Care developed for children with cancer. METHODS: We previously used qualitative methodologies to interview parents to identify four principles to inform the development of PCCPs. Then in this study a focus group with parents and multidisciplinary clinicians was conducted to assess the acceptability of the PCCP, suggest modifications, and provide input on its use. RESULTS: The PCCP is six-step pathway, starting with a standardized screening assessment with the Psychosocial Assessment Tool (PAT-HCT) that identifies the family's specific care needs. The focus group data support overall assessment with the PAT-HCT and the care principles underlying this approach. CONCLUSIONS: This PCCP is a systemic multidisciplinary model for providing psychosocial care that is ready for the next stage of development and evaluation in clinical care.

The importance of fathers in pediatric research: These authors are on to something important.

Pediatric obesity remains a prevalent health issue in the United States and around the world. Treatments are challenged by a lack of meaningful improvements in child healthy weight. The current commentary describes an intervention study with a unique approach: engaging fathers. The commentary describes why this approach is unique and promising in terms of future directions for the field to consider.