Pragmatic Health Assessment in Early Childhood: The PROMIS® of Developmentally Based Measurement for Pediatric Psychology.

OBJECTIVE: To illustrate the integration of developmental considerations into person-reported outcome (PRO) measurement development for application in early childhood pediatric psychology. METHODS: Combining the state-of-the-science Patient-Reported Outcome Measurement Information System (PROMIS®) mixed-methods instrument development approach with considerations from developmental measurement science, we developed 12 PROMIS early childhood (PROMIS EC) parent report measures to evaluate common mental, social, and physical health outcomes for ages 1-5. Through this interdisciplinary effort, we identified key considerations for early childhood PROs that enable reliable and valid assessment within the real-world constraints of clinical care settings. RESULTS: Four key considerations are highlighted as key to this process: (a) Engage diverse content experts to identify meaningful and relevant constructs; (b) Balance salient features for early childhood with lifespan coherence of constructs; (c) Emphasize observable features across the typical/atypical spectrum; and (d) Ensure feasibility and relevancy for clinical and research application. Each consideration is discussed using exemplars from the PROMIS EC measurement development process. CONCLUSIONS: PROMIS EC provides an illustration of how well-established PRO measures for youth can be adapted for younger children by incorporating developmental considerations. This process and resulting key considerations provide clinicians and researchers in the field of pediatric psychology with guidance for adapting PROs to early childhood, enabling critical continuity in domains of high salience to pediatric psychologists.

Topical Review: Enhancing Understanding of the Clinical Meaningfulness of Outcomes to Assess Treatment Benefit from Psychological Therapies for Children with Chronic Pain.

OBJECTIVE: Despite the availability of measures for assessing physical, psychological, and health impact in children with chronic pain, there are not established guidelines for interpretation of children's pain outcomes following psychological treatment. The purpose of this topical review is to discuss clinical significance as a neglected area of consideration in pediatric chronic pain assessment and to make recommendations on how the field can move toward benchmarking on core outcome domains. METHOD: We review definitions of clinical significance and examples of several methodologies that have been used in other populations or are emerging in pediatric chronic pain including anchor-based methods, distribution-based methods, or multimethod approaches. RESULTS: Few measures across pediatric chronic pain outcome domains have established clinical significance of scores to interpret meaningful change following treatment limiting the interpretability of findings from clinical trials. In the context of clinical practice, several efforts to examine clinical significance to improve the translation of evidence-based measurement into standard clinical decision-making exist. CONCLUSIONS: Recommendations are provided to encourage additional validation efforts of outcome measures in pediatric chronic pain and to encourage authors to report clinical significance in clinical trials of psychological interventions for pediatric chronic pain.

Featured Article: Bidirectional Effects of Sleep and Sedentary Behavior Among Toddlers: A Dynamic Multilevel Modeling Approach.

OBJECTIVE: To examine the bidirectional effects of objectively measured nighttime sleep and sedentary activity among toddlers. METHOD: Actical accelerometer data were analyzed for 195 toddlers participating in an obesity prevention trial (mean age = 27 months). Toddlers wore the accelerometers for up to 7 consecutive days. Nighttime sleep was defined as the number of minutes asleep between the hours of 8 pm and 8 am the following morning. Sedentary behavior (in minutes) was defined using previously established Actical cut points for toddlers. Variables were lagged and parsed into latent within- and between-person components, using dynamic structural equation modeling (DSEM). RESULTS: Toddlers spent an average of 172 min (∼3 hr) in sedentary activity and slept an average of 460 min (∼8 hr) per night. An autoregressive cross-lagged multilevel model revealed significant autoregression for both sleep and sedentary activity. Cross-lagged values revealed that decreased sleep predicted increased next-day sedentary activity, and sedentary activity predicted that night's sleep. For 89% of the sample, the within-person standardized cross-lagged effects of sleep on sedentary were larger than the cross-lagged effects of sedentary on sleep. CONCLUSIONS: Results suggest that, on average, nighttime sleep is a stronger predictor of subsequent sedentary behavior (compared with the reverse), and this is the case for the majority of toddlers. Findings highlight the importance of interindividual associations between sleep and sedentary activity. The present study is an example of how DSEM methods can be used to ask questions about Granger-causal cross-lagged relations between variables, both within and between individuals.

A Primer on Mixed Methods for Pediatric Researchers.

OBJECTIVE: To provide a primer on conducting and analyzing mixed methods research studies, and to provide guidance on the write-up of mixed methods research. METHODS: A question and answer format is used to provide an overview of mixed methods research study designs, tasks and considerations related to conducting and analyzing mixed methods studies, and recommendations for the write-up of results for mixed methods studies. RESULTS: Individuals who conduct mixed methods research are encouraged to delineate the quantitative, qualitative, and mixed methods features of the research and how these features fit with the overall study questions. Research teams will benefit from including individuals with expertise in qualitative, quantitative, and mixed methods research. Data integration should be a central component to the analysis and write-up of mixed methods research. CONCLUSIONS: Increasing the use of mixed methods research in the field of pediatric psychology will contribute to advances in observational studies with children and families, intervention development and evaluation, and creation of new tools and assessments that aim to optimize child and family health outcomes.

Topical Review: Integrating Findings on Direct Observation of Family Communication in Studies Comparing Pediatric Chronic Illness and Typically Developing Samples.

Objective: To review research on observed family communication in families with children with chronic illnesses compared with families with healthy, typically developing children, and to integrate findings utilizing a unifying family communication framework. Method: Topical review of studies that have directly observed family communication in pediatric populations and included a typically developing comparison group. Results: Initial findings from 14 studies with diverse approaches to quantifying observed family communication suggest that families with children with chronic illnesses may demonstrate lower levels of warm and structured communication and higher levels of hostile/intrusive and withdrawn communication compared with families with healthy, typically developing children. Conclusion: An integrative framework of family communication may be used in future studies that examine the occurrence, correlates, and mechanisms of family communication in pediatric populations.

Use of Unannounced Telephone Pill Counts to Measure Medication Adherence Among Adolescents and Young Adults Living With Perinatal HIV Infection.

Objective: To examine unannounced telephone pill counts as a measure of adherence to antiretroviral therapy among adolescents and young adults living with perinatal HIV infection. Methods: Participants were recruited from an ongoing longitudinal study to complete four monthly, unannounced telephone pill counts. Detailed notes concerning participants' medication habits surrounding adherence were recorded. Results: Two-thirds of 102 eligible participants aged 18-27 years participated; 57% were female, 69% were Black. Blacks and participants with viral loads >40 and >1,000 copies/ml were less likely to participate. Average adherence across calls was 77%. Those who completed all calls averaged significantly higher adherence scores than those who did not. Calls revealed adherence barriers at individual (e.g., medication disorganization), social (e.g., limited support), and system (e.g., pharmacy problems) levels. Conclusions: Despite challenges, this procedure can be implemented with this population and can help identify adherence barriers important for interventions that address medication-taking behaviors.

Topical Review: Families Coping With Child Trauma: A Naturalistic Observation Methodology.

OBJECTIVE: To introduce a novel, naturalistic observational methodology (the Electronically Activated Recorder; EAR) as an opportunity to better understand the central role of the family environment in children's recovery from trauma. METHODS: Discussion of current research methods and a systematic literature review of EAR studies on health and well-being. RESULTS: Surveys, experience sampling, and the EAR method each provide different opportunities and challenges for studying family interactions. We identified 17 articles describing relevant EAR studies. These investigated questions of emotional well-being, communicative behaviors, and interpersonal relationships, predominantly in adults. 5 articles reported innovative research in children, triangulating EAR-observed behavioral data (e.g., on child conflict at home) with neuroendocrine assay, sociodemographic information, and parent report. Finally, we discussed psychometric, practical, and ethical considerations for conducting EAR research with children and families. CONCLUSIONS: Naturalistic observation methods such as the EAR have potential for pediatric psychology studies regarding trauma and the family environment.

Predicting Later Study Withdrawal in Participants Active in a Longitudinal Birth Cohort Study for 1 Year: The TEDDY Study.

OBJECTIVE: To identify predictors of later study withdrawal among participants active in The Environmental Determinants of Diabetes in the Young (TEDDY) for 1 year. METHODS: Multiple logistic regression was used to discriminate 3,042 children active in TEDDY for the first 3 years from 432 children who withdrew in Years 2 or 3. Predictor variables were tested in blocks-demographic, maternal lifestyle behaviors, stress and child illness, maternal reactions to child's increased diabetes risk, in-study behaviors-and a final best model developed. RESULTS: Few demographic factors predicted study withdrawal. Maternal lifestyle behaviors, accuracy of the mother's risk perception, and in-study behaviors were more important. Frequent child illnesses were associated with greater study retention. CONCLUSIONS: Demographic measures are insufficient predictors of later study withdrawal among those active in a study for at least 1 year; behavioral/psychological factors offer improved prediction and guidance for the development of retention strategies.

Topical Review: Theoretical Frameworks in Pediatric Adherence-Promotion Interventions: Research Findings and Methodological Implications.

OBJECTIVE: To summarize the guiding theoretical frameworks included in pediatric adherence-promotion interventions and characterize targeted domains using the theoretical domains framework (TDF), a standardized system developed by adult behavior change researchers. METHODS: A systematic review of PubMed, PsycINFO, and CINAHL databases identified 47 articles describing pediatric adherence-promotion interventions. Data extraction was completed independently by two authors. Targeted intervention domains were classified using the TDF. RESULTS: The majority of interventions did not cite a guiding theoretical framework or cited multiple theories with overlapping domains. The TDF was a reliable categorization system and suggested that pediatric adherence-promotion interventions most commonly target knowledge, skills, and social influences. CONCLUSIONS: Pediatric adherence-promotion interventions draw from a variety of theories and lack a consistent language for describing targeted domains. The adapted TDF proposed here is one method of reducing variability in intervention development and reporting and may facilitate efforts to identify the processes that improve adherence.

Electronic monitoring of medication adherence in early maintenance phase treatment for pediatric leukemia and lymphoma: identifying patterns of nonadherence.

OBJECTIVE: To describe patterns of treatment adherence to early maintenance phase therapy for acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL). METHODS: Using an objective observational method (electronic monitoring), adherence was examined for 139 patients aged 7-19 years diagnosed with ALL or LBL across 6 centers. RESULTS: The mean adherence percentage was 86.2%. Adherence rates declined over the 1-month of follow-up to 83%. 3 linear trajectories of 6-mercaptopurine adherence were identified: (1) exemplary adherence (n = 99): Averaging nearly 100%; (2) deteriorating (n = 23): Adherence decreased from 100 to 60%; and (3) chronically poor adherence (n = 9): Averaging 40%. CONCLUSIONS: Adherence promotion interventions might be tailored to subgroups of patients who demonstrated problematic patterns of treatment adherence that could place them at risk for relapse. This research demonstrates the importance of using objective real-time measures of medication adherence for measuring and documenting adherence patterns.

An examination of 1-year adherence and persistence rates to antiepileptic medication in children with newly diagnosed epilepsy.

OBJECTIVE: The primary aim of the current study was to use new methods to examine 1-year quality of medication dosing (adherence) and continuation with medication treatment (persistence) rates to antiepileptic drugs (AEDs) in children with newly diagnosed epilepsy. METHODS: Medication-taking behaviors of AEDs were assessed using electronic monitors for 117 children with newly diagnosed epilepsy for the first year after diagnosis. RESULTS: Approximately 15% of participants were categorized as nonpersistent (i.e., failed to take medication for >15 consecutive days) 6 months after AED initiation, which increased to 26.6% of participants at 1 year. The majority of medication dosing events took place within a +/-2-hr interval as recommended. The group with lower socioeconomic status demonstrated more nonpersistence over time. CONCLUSION: Examining adherence and persistence in medication taking behaviors may yield different types of data for clinical and research purposes.

Single-case research design in pediatric psychology: considerations regarding data analysis.

OBJECTIVE: Single-case research allows for an examination of behavior and can demonstrate the functional relation between intervention and outcome in pediatric psychology. This review highlights key assumptions, methodological and design considerations, and options for data analysis. METHODS: Single-case methodology and guidelines are reviewed with an in-depth focus on visual and statistical analyses. RESULTS: Guidelines allow for the careful evaluation of design quality and visual analysis. A number of statistical techniques have been introduced to supplement visual analysis, but to date, there is no consensus on their recommended use in single-case research design. CONCLUSIONS: Single-case methodology is invaluable for advancing pediatric psychology science and practice, and guidelines have been introduced to enhance the consistency, validity, and reliability of these studies. Experts generally agree that visual inspection is the optimal method of analysis in single-case design; however, statistical approaches are becoming increasingly evaluated and used to augment data interpretation.

A framework for assessment of adverse events occurring in psychedelic-assisted therapies.

OBJECTIVE: Despite considerable research examining the efficacy of psychedelic-assisted therapies (PATs) for treating psychiatric disorders, assessment of adverse events (AEs) in PAT research has lagged. Current AE reporting standards in PAT trials are poorly calibrated to features of PAT that distinguish it from other treatments, leaving many potential AEs unassessed. METHODS: A multidisciplinary working group of experts involved in PAT pooled formally and informally documented AEs observed through research experience and published literature. This information was integrated with (a) current standards and practices for AE reporting in pharmacotherapy and psychotherapy trials and (b) published findings documenting post-acute dosing impacts of psychedelics on subjective states, meaning, and psychosocial health variables, to produce a set of AE constructs important to evaluate in PAT as well as recommended methods and time frames for their assessment and monitoring. Correspondence between identified potential AEs and current standards for AE assessment was examined, including the extent of coverage of identified AE constructs by 25 existing measures used in relevant research. RESULTS: Fifty-four potential AE terms warranting systematized assessment in PAT were identified, defined, and categorized. Existing measures demonstrated substantial gaps in their coverage of identified AE constructs. Recommendations were developed for how to assess PAT AEs (including patient, clinician, and informant reports), and when to assess over preparation, dosing session, integration, and follow-up. Application of this framework is demonstrated in a preliminary assessment protocol (available in the supplement). CONCLUSIONS: This assessment framework addresses the need to capture post-acute dosing AEs in PAT, accounting for its pharmacotherapy and psychotherapy components, as well as documented impacts of psychedelics on worldviews and spirituality.

Structural intervention at one bridge decreases the overall jumping suicide rate in Victoria, Australia.

AIMS: There is clear evidence that installing safety barriers is effective in preventing jumping suicides from high-risk bridges with only moderate displacement to other nearby bridges. However, the impact of barriers on jumping suicides across broader geographical areas is not well understood. We examined patterns in jumping suicides across the state of Victoria, Australia, after a safety barrier was installed at the West Gate Bridge which, before the installation of the barrier, was the site of approximately 40% of Victoria's jumping suicides. METHODS: We used negative binomial regression analyses on Victorian data from 2000 to 2019 to compare rates of jumping suicides at the West Gate Bridge, other bridges and non-bridge jumping locations before, during and after the West Gate Bridge barrier installation. We conducted linear regression analyses to examine whether the distance travelled from the deceased's usual residence to the location of their jumping suicide changed between the before, during and after barrier installation periods. RESULTS: After installation of the barrier, there were no jumping suicides at the West Gate Bridge (rate ratio [RR] = 0.00, 95% credible intervals [95% Cr] = 0.00-0.0001) and there was strong evidence that the rate of jumping suicides at all locations declined by 65% (RR = 0.35, 95% Cr = 0.22-0.54). At other bridges, there was also evidence of a reduction (RR = 0.31, 95% Cr = 0.11-0.70), but there was no evidence of a change at non-bridge locations (RR = 0.74, 95% Cr = 0.39-1.30). CONCLUSION: After installation of the safety barrier at the West Gate Bridge, jumping suicide in Victoria decreased overall and at other bridges, and did not appear to change at non-bridge locations. Our findings show that when barriers are installed at a site responsible for a disproportionately high number of jumping suicides, they are not only highly effective at the site where the barriers are installed but can also have a prevention impact beyond the immediate locale at similar sites.

The Bay Area Muslim mental health community advisory board: evaluation of a community based participatory approach.

AIMS: The aim of this paper is to present a novel case for the formation, operation and evaluation of a community advisory aboard comprised of Muslims residing in the San Francisco Bay Area, California that utilised a community based participatory approach to address local Muslim mental health needs. The CAB was recruited in partnership with the Muslim Community Association (MCA), one of the largest Islamic centres in the San Franscisco Bay Area. In addition to describing the development of the CAB, the authors present the findings of the evaluation and synthesis of best processes based on CAB members' feedback. METHODS: To evaluate the perceived community advisory board members' perceptions of their roles and elicit feedback on how to enhance the relationship between the university team and the CAB, an evaluation was conducted by an independent team who was not part of the research process. Data was collected using anonymous individual surveys and small group open discussions that were conducted over three evaluation meetings. The evaluation utilised mixed method data collection strategies using questions from Schulz et al. (, Evaluation and Program Planning 26, 249-262), an instrument for evaluating dimensions of group dynamics within CBPR partnerships. RESULTS: Results of the evaluation within the sphere of CAB operation indicated that CAB members found the greatest satisfaction from their contributions through direct participation in the research activities that were conducted by the university-CAB team. The collective responses indicated that most CAB members were satisfied with trust built between the university-CAB team and the diversity represented in the members of the board. However, given that the Bay Area is home to a very diverse Muslim community, challenges in recruiting representatives that account for all possible self-identifying groups was reported by the CAB with recommendations to recruit religious leaders. Recommendations also included eliciting funds for potential financial compensation for CAB members. CONCLUSIONS: The Stanford-San Francisco Bay Area CAB demonstrated that empowering community members through direct participation, creating channels and safe spaces for feedback help create community rooted research that carry the true voices of marginalised communities and reflects their evolving needs.

Insights for Conducting Large-Scale Surveys with Veterans Who Have Experienced Homelessness.

Surveys of underserved patient populations are needed to guide quality improvement efforts but are challenging to implement. The goal of this study was to describe recruitment and response to a national survey of Veterans with homeless experience (VHE). We randomly selected 14,340 potential participants from 26 U.S. Department of Veterans Affairs (VA) facilities. A survey contract organization verified/updated addresses from VA administrative data with a commercial address database, then attempted to recruit VHE through 4 mailings, telephone follow-up, and a $10 incentive. We used mixed-effects logistic regressions to test for differences in survey response by patient characteristics. The response rate was 40.2% (n=5,766). Addresses from VA data elicited a higher response rate than addresses from commercial sources (46.9% vs 31.2%, p<.001). Residential addresses elicited a higher response rate than business addresses (43.8% vs 26.2%, p<.001). Compared to non-respondents, respondents were older, less likely to have mental health, drug, or alcohol conditions, and had fewer VA housing and emergency service visits. Collectively, our results indicated a national mailed survey approach is feasible and successful for reaching VA patients who have recently experienced homelessness. These findings offer insight into how health systems can obtain perspectives of socially disadvantaged groups.

Considerations for supporting meaningful stakeholder engagement in global mental health research.

The need to ensure that research evidence is adopted by health systems and is informed by lived experience expertise has been increasingly recognised in mental health research. In the field of global mental health (GMH), though some progress has been made, the meaningful engagement of key stakeholders in research remains low. This editorial outlines recommendations to support the meaningful engagement of policy makers and people with lived or living experience of mental illness in GMH research. Recommendations include: increasing funding structures that are designed to support meaningful engagement; urging institutions to consider administrative structures that support engagement with lower resourced partners; promoting capacity development opportunities and resources to support researchers to promote meaningful engagement; developing research governance structures that include key stakeholders; and, taking steps to ensure the needs of diverse stakeholders are met through their engagement in research. Examples of good practice from these areas are provided. Though not an exhaustive list of recommendations, this editorial represents a call to the GMH research community to take a deliberate and proactive approach to prioritising meaningful stakeholder engagement in GMH research with the ultimate goal of improving accessible and appropriate mental health care.

Innovative Directions to Advance Mental Health Disparities Research.

Disparities in mental health have persisted or worsened despite our awareness of their existence, increased understanding of their causes, and efforts at reduction and mitigation. Although much is known, there is still much to be done in mental health research to meaningfully impact disparities. In November 2020, the National Institute of Mental Health (NIMH) and the National Institute of Minority Health and Health Disparities (NIMHD) co-sponsored a virtual workshop to explore the complexities of mental health disparities, which revealed several gaps and opportunities for the field to pursue to advance mental health disparities research. This article, the introduction to a Special Issue on Mental Health Disparities, provides a frame for four articles that stem from and are inspired by the virtual NIMH/NIMHD workshop, all of which illustrate innovative research on understanding the complex mechanisms of disparities and how this knowledge can be translated into effective intervention development that advances mental health equity.

Lack of Representation in Psychiatric Research: A Data-Driven Example From Scientific Articles Published in 2019 and 2020 in the American Journal of Psychiatry.

OBJECTIVE: The authors examined representation and accuracy of descriptions of sociodemographic identities in psychiatric research through quantifying data contained in recently published articles from a high-impact psychiatry journal. METHODS: Sociodemographic data were aggregated from articles (i.e., studies that provide information on individual samples) published in the American Journal of Psychiatry in 2019 and 2020 (N=125). Articles were coded by two raters for sociodemographic data, acknowledgment of lack of representation as a limitation, and focus on health disparities or inequities. RESULTS: While 90% of studies provided the age of participants and 84% provided information about the sex/gender of participants, only 43% presented information about the racial or ethnicity identities of participants. One study reported the sexual identity of participants. Lack of representation relative to 2019 U.S. Census data was found for multiple racial groups, Latino/Hispanic individuals, and women (genetic studies only). Only 25% of studies acknowledged lack of representation as a limitation, and two studies focused on health disparities or inequities. CONCLUSIONS: These findings highlight a need to increase representation in psychiatric research and improve accuracy of language when describing the sociodemographic characteristics of participants.

Uncovering survivorship bias in longitudinal mental health surveys during the COVID-19 pandemic.

AIMS: Markedly elevated adverse mental health symptoms were widely observed early in the coronavirus disease-2019 (COVID-19) pandemic. Unlike the U.S., where cross-sectional data indicate anxiety and depression symptoms have remained elevated, such symptoms reportedly declined in the U.K., according to analysis of repeated measures from a large-scale longitudinal study. However, nearly 40% of U.K. respondents (those who did not complete multiple follow-up surveys) were excluded from analysis, suggesting that survivorship bias might partially explain this discrepancy. We therefore sought to assess survivorship bias among participants in our longitudinal survey study as part of The COVID-19 Outbreak Public Evaluation (COPE) Initiative. METHODS: Survivorship bias was assessed in 4039 U.S. respondents who completed surveys including the assessment of mental health as part of The COPE Initiative in April 2020 and were invited to complete follow-up surveys. Participants completed validated screening instruments for symptoms of anxiety, depression and insomnia. Survivorship bias was assessed for (1) demographic differences in follow-up survey participation, (2) differences in initial adverse mental health symptom prevalence adjusted for demographic factors and (3) differences in follow-up survey participation based on mental health experiences adjusted for demographic factors. RESULTS: Adjusting for demographics, individuals who completed only one or two out of four surveys had significantly higher prevalence of anxiety and depression symptoms in April 2020 (e.g. one-survey v. four-survey, anxiety symptoms, adjusted prevalence ratio [aPR]: 1.30, 95% confidence interval [CI]: 1.08-1.55, p = 0.0045; depression symptoms, aPR: 1.43, 95% CI: 1.17-1.75, p = 0.00052). Moreover, individuals who experienced incident anxiety or depression symptoms had significantly higher adjusted odds of not completing follow-up surveys (adjusted odds ratio [aOR]: 1.68, 95% CI: 1.22-2.31, p = 0.0015, aOR: 1.56, 95% CI: 1.15-2.12, p = 0.0046, respectively). CONCLUSIONS: Our findings reveal significant survivorship bias among longitudinal survey respondents, indicating that restricting analytic samples to only respondents who provide repeated assessments in longitudinal survey studies could lead to overly optimistic interpretations of mental health trends over time. Cross-sectional or planned missing data designs may provide more accurate estimates of population-level adverse mental health symptom prevalence than longitudinal surveys.