Development of an International Standard Set of Outcomes and Measurement Methods for Routine Practice for Infants, Children, and Adolescents with Epilepsy: The International Consortium for Health Outcomes Measurement Consensus Recommendations.

At present, there is no internationally accepted set of core outcomes or measurement methods for epilepsy clinical practice. The International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group of experts in epilepsy, people with epilepsy, and their representatives to develop minimum sets of standardized outcomes and outcome measurement methods for clinical practice. Using modified Delphi consensus methods with consecutive rounds of online voting over 12 months, a core set of outcomes and corresponding measurement tool packages to capture the outcomes were identified for infants, children, and adolescents with epilepsy. Consensus methods identified 20 core outcomes. In addition to the outcomes identified for the ICHOM Epilepsy adult standard set, behavioral, motor, and cognitive/language development outcomes were voted as essential for all infants and children with epilepsy. The proposed set of outcomes and measurement methods will facilitate the implementation of the use of patient-centered outcomes in daily practice.

Development of an International Standard Set of Outcomes and Measurement Methods for Routine Practice for Adults with Epilepsy: The International Consortium for Health Outcomes Measurement Consensus Recommendations.

At present, there is no internationally accepted set of core outcomes or measurement methods for epilepsy clinical practice. Therefore, the International Consortium for Health Outcomes Measurement (ICHOM) convened an international working group of experts in epilepsy, people with epilepsy and their representatives to develop minimum sets of standardized outcomes and outcomes measurement methods for clinical practice that support patient-clinician decision-making and quality improvement. Consensus methods identified 20 core outcomes. Measurement tools were recommended based on their evidence of strong clinical measurement properties, feasibility, and cross-cultural applicability. The essential outcomes included many non-seizure outcomes: anxiety, depression, suicidality, memory and attention, sleep quality, functional status, and the social impact of epilepsy. The proposed set will facilitate the implementation of the use of patient-centered outcomes in daily practice, ensuring holistic care. They also encourage harmonization of outcome measurement, and if widely implemented should reduce the heterogeneity of outcome measurement, accelerate comparative research, and facilitate quality improvement efforts.

Epilepsy-related stigma and attitudes: Systematic review of screening instruments and interventions - Report by the International League Against Epilepsy Task Force on Stigma in Epilepsy.

OBJECTIVE: This is a systematic review aimed at summarizing the evidence related to instruments that have been developed to measure stigma or attitudes toward epilepsy and on stigma-reducing interventions. METHODS: This review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standards. A broad literature search (1985-2019) was performed in 13 databases. Articles were included if they described the development and testing of psychometric properties of an epilepsy-related stigma or attitude scale or stigma-reducing interventions. Two reviewers independently screened abstracts, reviewed full-text articles, and extracted data. Basic descriptive statistics are reported. RESULTS: We identified 4234 abstracts, of which 893 were reviewed as full-text articles. Of these, 38 met inclusion criteria for an instrument development study and 30 as a stigma-reduction intervention study. Most instruments were initially developed using well-established methods and were tested in relatively large samples. Most intervention studies involved educational programs for adults with pre- and post-evaluations of attitudes toward people with epilepsy. Intervention studies often failed to use standardized instruments to quantify stigmatizing attitudes, were generally underpowered, and often found no evidence of benefit or the benefit was not sustained. Six intervention studies with stigma as the primary outcome had fewer design flaws and showed benefit. Very few or no instruments were validated for regional languages or culture, and there were very few interventions tested in some regions. SIGNIFICANCE: Investigators in regions without instruments should consider translating and further developing existing instruments rather than initiating the development of new instruments. Very few stigma-reduction intervention studies for epilepsy have been conducted, study methodology in general was poor, and standardized instruments were rarely used to measure outcomes. To accelerate the development of effective epilepsy stigma-reduction interventions, a paradigm shift from disease-specific, siloed trials to collaborative, cross-disciplinary platforms based upon unified theories of stigma transcending individual conditions will be needed.

Social determinants of health associated with epilepsy treatment adherence in the United States: A scoping review.

PURPOSE: The aim of this paper is to share the results of a scoping review in which we examined the social determinants of health (SDoH) that are associated with anti-seizure medication (ASM) treatment adherence among people living with epilepsy in the United States. METHODS: Our review was informed by the methods of Arksey and O'Malley for a scoping review. A total of 3,826 articles were identified for reference through a literature search, of which 17 publications were deemed relevant to our scoping review. The final articles were mapped using the Epilepsy SDoH Conceptual Framework to identify gaps. FINDINGS: Our review suggests that there are multidimensional associations of SDoH in ASM adherence. The SDoH were interrelated. Race/ethnicity and socioeconomic status appeared to have major associations with ASM adherence. Several gaps in the literature were identified, including inadequately exploring the effect that each SDoH has on treatment adherence, and the methods used for assessment. CONCLUSIONS: Future longitudinal research to address the identified gaps would foster interventions that promote ASM adherence among vulnerable populations living with epilepsy.

Exploring the relationship between parent-child communication about epilepsy and psychosocial well-being.

This study examined the relationship between parent-child communication and psychosocial well-being of 47 children living with epilepsy and 72 parents of children living with epilepsy. Open communication was associated with positive illness attitude, positive self-perception and greater health-related quality of life for children living with epilepsy; positive response to illness for parents; and more perceived social support and less need for epilepsy-related support for children living with epilepsy and parents. By contrast, closed communication was associated with poorer psychosocial well-being in children living with epilepsy and parents. Healthcare professionals should provide guidance for families living with childhood epilepsy on the importance of open communication in promoting greater psychosocial well-being.

Precision health: Advancing symptom and self-management science.

BACKGROUND: Precision health considers individual lifestyle, genetics, behaviors, and environment context and facilitates interventions aimed at helping individuals achieve well-being and optimal health. PURPOSE: To present the Nursing Science Precision Health (NSPH) Model and describe the integration of precision health concepts within the domains of symptom and self-management science as reflected in the National Institute of Nursing Research P30 Centers of Excellence and P20 Exploratory Centers. METHODS: Center members developed the NSPH Model and the manuscript based on presentations and discussions at the annual NINR Center Directors Meeting and in follow-up telephone meetings. DISCUSSION: The NSPH Model comprises four precision components (measurement; characterization of phenotype including lifestyle and environment; characterization of genotype and other biomarkers; and intervention target discovery, design, and delivery) that are underpinned by an information and data science infrastructure. CONCLUSION: Nurse scientist leadership is necessary to realize the vision of precision health as reflected in the NSPH Model.

Development and psychometric evaluation of the youth and parent versions of the Epilepsy Disclosure Scale (EDS).

OBJECTIVES: The aim of this paper was to describe the development and psychometric evaluation of new Epilepsy Disclosure Scales (EDSs) for youths with epilepsy (YWE) and their parents. METHODS: Developing the EDSs for youths and parents comprised a number of stages, including questionnaire construction and item development for the new EDSs (consisting of a pilot and review of the newly developed EDSs) and psychometric evaluation of the measures to assess their appropriateness, factor structure, reliability, and validity. Psychometric properties were determined using a cross-sectional survey of 47 YWE and 72 parents. RESULTS: Two scales were developed to assess the epilepsy disclosure behaviors of YWE and their parents; that is, the extent to which they tell and talk to others about the child's epilepsy. The youth version of the EDS comprised six items and had a unidimensional factor structure that explained 55% of the variance. The parent version of the EDS also consisted of six items, with a single factor explaining 47% of the variance. The suitability, validity, and reliability of the youth and parent versions of EDSs were supported by positive indicators, such as a high Cronbach's alpha (representative of good internal consistency) and the confirmation of a number of hypothesized relationships between epilepsy disclosure and psychosocial and illness attitude variables (demonstrative of their convergent validity). CONCLUSION: Prior to the development of these instruments, no valid and reliable measures existed that could suitably capture disclosure amongst populations living with epilepsy. The youth and parent versions of the EDS are valid, reliable, brief, and easily administered and thus could prove useful in research as well as in the clinical setting. These scales will enable researchers and clinicians to profile the epilepsy disclosure behaviors of YWE and their parents, which play an important role and have implications both for the psychosocial wellbeing of families living with epilepsy and for epilepsy-related stigma.

Family rituals in pediatric epilepsy: Links to parental competence and adaptation.

This cross-sectional study examined the associations between family ritual meaning and 3 indicators of parental adaptation (anxious and depressive symptoms and quality of life) via 2 dimensions of parental competence-satisfaction and efficacy-in parents of children with epilepsy. Two hundred Portuguese parents of children diagnosed with epilepsy for at least 6 months completed self-report measures assessing the main study variables. Our results showed that when parents reported stronger family ritual meaning, they also reported higher levels of parental satisfaction and efficacy, which were in turn were associated with lower psychological distress (anxious and depressive symptoms) and better quality of life of parents. This pattern of results was significant regardless of the severity of children's epilepsy, age group, and family socioeconomic level. In the context of pediatric epilepsy, empirical evidence was found for the role of family ritual meaning in being directly and indirectly associated with parents' adaptation outcomes by higher levels of parental satisfaction and efficacy. Focusing intervention targets on what families naturally do and recognize as their own ritual meaning may be a favorable route to address those at risk of psychological distress and lower quality of life. (PsycINFO Database Record

Biomarkers as Common Data Elements for Symptom and Self-Management Science.

PURPOSE: Biomarkers as common data elements (CDEs) are important for the characterization of biobehavioral symptoms given that once a biologic moderator or mediator is identified, biologically based strategies can be investigated for treatment efforts. Just as a symptom inventory reflects a symptom experience, a biomarker is an indicator of the symptom, though not the symptom per se. The purposes of this position paper are to (a) identify a "minimum set" of biomarkers for consideration as CDEs in symptom and self-management science, specifically biochemical biomarkers; (b) evaluate the benefits and limitations of such a limited array of biomarkers with implications for symptom science; (c) propose a strategy for the collection of the endorsed minimum set of biologic samples to be employed as CDEs for symptom science; and (d) conceptualize this minimum set of biomarkers consistent with National Institute of Nursing Research (NINR) symptoms of fatigue, depression, cognition, pain, and sleep disturbance. DESIGN AND METHODS: From May 2016 through January 2017, a working group consisting of a subset of the Directors of the NINR Centers of Excellence funded by P20 or P30 mechanisms and NINR staff met bimonthly via telephone to develop this position paper suggesting the addition of biomarkers as CDEs. The full group of Directors reviewed drafts, provided critiques and suggestions, recommended the minimum set of biomarkers, and approved the completed document. Best practices for selecting, identifying, and using biological CDEs as well as challenges to the use of biological CDEs for symptom and self-management science are described. Current platforms for sample outcome sharing are presented. Finally, biological CDEs for symptom and self-management science are proposed along with implications for future research and use of CDEs in these areas. FINDINGS: The recommended minimum set of biomarker CDEs include pro- and anti-inflammatory cytokines, a hypothalamic-pituitary-adrenal axis marker, cortisol, the neuropeptide brain-derived neurotrophic factor, and DNA polymorphisms. CONCLUSIONS: It is anticipated that this minimum set of biomarker CDEs will be refined as knowledge regarding biologic mechanisms underlying symptom and self-management science further develop. The incorporation of biological CDEs may provide insights into mechanisms of symptoms, effectiveness of proposed interventions, and applicability of chosen theoretical frameworks. Similarly, as for the previously suggested NINR CDEs for behavioral symptoms and self-management of chronic conditions, biological CDEs offer the potential for collaborative efforts that will strengthen symptom and self-management science. CLINICAL RELEVANCE: The use of biomarker CDEs in biobehavioral symptoms research will facilitate the reproducibility and generalizability of research findings and benefit symptom and self-management science.

Measurement in pediatric epilepsy self-management: A critical review.

Given the paucity of information available regarding self-management, the aims of this paper are to synthesize the literature on factors associated with and measures to assess self-management in pediatric epilepsy. INCLUSION CRITERIA: youth birth to 18 years with a seizure disorder or an epilepsy diagnosis and/or their caregivers, published 1985-2014 in English, and conducted in countries with a very high human development index. The review was conducted in 6 phases: (1) identification of bibliographical search criteria and databases; (2) abstract assessment; (3) full article review; (4) organization of final citations into categories; (5) identification of predictors, potential mediators/moderators, and outcomes associated with self-management factors and categorization of factors as influences, processes, or behaviors across individual, family, community, and health care domains; and (6) critique of self-management instrument studies. Twenty-five studies that evaluated factors associated with self-management were identified. Individual and family-focused factors were the most commonly studied predictors of self-management, with psychosocial care needs and self-efficacy for seizure management identified as key factors associated with pediatric epilepsy self-management. Few studies have included mediator and moderator analyses. Measures of adherence were the most commonly used outcome. There has been a predominant focus on pediatric epilepsy influences and processes that are modifiable in nature, potentially at the expense of evidence for the role of community and health systems in pediatric epilepsy self-management. The 6 self-management instrument tools reported scientific rationale and good psychometric properties. Results highlight several key modifiable cognitive and behavioral targets for skills development: adherence, self-efficacy for seizure management, attitudes toward epilepsy, and family variables. Moving forward, a comprehensive pediatric epilepsy self-management model, well-validated measures of self-management behaviors, mediator/moderator designs to examine the complex relationships between predictors and pediatric epilepsy self-management outcomes, and studies examining the community and health care domains of self-management are necessary.

The psychological costs of comparisons: Parents' social comparison moderates the links between family management of epilepsy and children's outcomes.

Parents play a key role in how children deal with epilepsy. When diagnosed with health conditions, people seek comparison information from fellow patients and families, and this information has consequences for how they evaluate their situation. This study examined the moderating role of parents' social comparison orientation in the associations between family management (parental perceptions of family life difficulties and child's daily life) and adaptation outcomes of children with epilepsy (HRQoL and perceived stigma). Participants included 201 dyads of children with epilepsy and either their mother or father. The results showed that when parents perceived higher difficulties managing their child's epilepsy and/or reported that their child was more affected by this condition, children reported higher perceived stigma and worse HRQoL only when parents had a higher social comparison orientation. Our results are innovative in showing that when parents have a higher social comparison orientation, their children may be at increased risk of poorer outcomes.

Feasibility of Combining Common Data Elements Across Studies to Test a Hypothesis.

PURPOSE: The purpose of this article is to describe the outcomes of a collaborative initiative to share data across five schools of nursing in order to evaluate the feasibility of collecting common data elements (CDEs) and developing a common data repository to test hypotheses of interest to nursing scientists. This initiative extended work already completed by the National Institute of Nursing Research CDE Working Group that successfully identified CDEs related to symptoms and self-management, with the goal of supporting more complex, reproducible, and patient-focused research. DESIGN: Two exemplars describing the group's efforts are presented. The first highlights a pilot study wherein data sets from various studies by the represented schools were collected retrospectively, and merging of the CDEs was attempted. The second exemplar describes the methods and results of an initiative at one school that utilized a prospective design for the collection and merging of CDEs. METHODS: Methods for identifying a common symptom to be studied across schools and for collecting the data dictionaries for the related data elements are presented for the first exemplar. The processes for defining and comparing the concepts and acceptable values, and for evaluating the potential to combine and compare the data elements are also described. Presented next are the steps undertaken in the second exemplar to prospectively identify CDEs and establish the data dictionaries. Methods for common measurement and analysis strategies are included. FINDINGS: Findings from the first exemplar indicated that without plans in place a priori to ensure the ability to combine and compare data from disparate sources, doing so retrospectively may not be possible, and as a result hypothesis testing across studies may be prohibited. Findings from the second exemplar, however, indicated that a plan developed prospectively to combine and compare data sets is feasible and conducive to merged hypothesis testing. CONCLUSIONS: Although challenges exist in combining CDEs across studies into a common data repository, a prospective, well-designed protocol for identifying, coding, and comparing CDEs is feasible and supports the development of a common data repository and the testing of important hypotheses to advance nursing science. CLINICAL RELEVANCE: Incorporating CDEs across studies will increase sample size and improve data validity, reliability, transparency, and reproducibility, all of which will increase the scientific rigor of the study and the likelihood of impacting clinical practice and patient care.

Self-management interventions in pediatric epilepsy: What is the level of evidence?

OBJECTIVE: To respond to recommendations put forth by the Institute of Medicine to improve self-management resources for youth with epilepsy by conducting a systematic review of the self-management literature in pediatric epilepsy. METHODS: Inclusion criteria: youth birth to 18 years with a seizure disorder or an epilepsy diagnosis and/or their caregivers, published 1985-2014 in English, and conducted in countries with a very high human development index. Abstract and keywords had to explicitly refer to "self-care" (pre-1996) and/or self-management (post-1996). The review was conducted in seven phases: (1) identification of bibliographical search criteria and databases; (2) abstract assessment; (3) full article review; (4) organization of final citations into instrument development, intervention, factors associated with self-management categories; (5) American Academy of Neurology level of evidence (LOE) assessment for intervention studies; (6) CONsolidated Standards of Reporting Trials (CONSORT) evaluation of LOE level III articles utilizing a control group; and (7) categorization of intervention outcomes across four self-management domains. RESULTS: Of the 87 articles that met eligibility criteria, 24 were interventions and received LOE scores of level III or IV. Most studies (n = 20, 80%) were scored at level III; however, only eight had a control group and adhered to CONSORT guidelines. They largely neglected information on intervention components (e.g., implementation, treatment fidelity), randomization, participant flow, missing data, and effect size or confidence intervals. The 24 intervention studies reported significant impact in four domains: individual (n = 13), family (n = 6), health care system (n = 3), and community (n = 2). SIGNIFICANCE: There are no level I or II studies. No study met full CONSORT guidelines. Outcomes were well described; however, the nature of self-management interventions (e.g., multiple foci, skills targeted) and the observed heterogeneity in outcomes complicates comparisons across studies. Randomized controlled trials (RCTs) that include large sample sizes, impact of the intervention, treatment fidelity, and power analyses are necessary to further this evidence base.

Family Cohesion, Stigma, and Quality of Life in Dyads of Children With Epilepsy and Their Parents.

Objective: To examine the mediating role of stigma on the links between family cohesion and quality of life (QoL) in children with epilepsy and their parents. Participants were 192 families attending three Portuguese public hospitals. Children and parents completed self-report measures of family cohesion, stigma, QoL, and health-related QoL (HRQoL). Neurologists assessed clinical variables. Structural equation modeling within the framework of the actor-partner interdependence model was used. The final model showed a good fit to the data, explaining 43% and 35% of the QoL outcomes of children and parents, respectively. Family cohesion was positively linked to QoL outcomes, directly for children and parents, and indirectly for children only, by way of negative links with perceived stigma. At the dyadic level, parents' perceptions of family cohesion were positively associated with children's HRQoL. A routine screening of those patients experiencing poorer HRQoL should include the assessment of family relationships and stigma.

Parent perspectives of the challenging aspects of disclosing a child's epilepsy diagnosis to others: Why don't they tell?

Objectives This study aimed to explore the challenges parents of children with epilepsy (CWE) experienced when deciding to disclose their child's epilepsy diagnosis to others. Methods Using a qualitative exploratory design, interviews were conducted with 34 parents (27 mothers and 7 fathers) of 29 CWE (aged 6-16 years). Parents were recruited from a neurology clinic of a specialist children's hospital and from a national epilepsy association. Interviews were directed by a semi-structured guide informed by a review of the literature. Data were transcribed verbatim, imported into NVivo, coded and thematically analysed. Results Findings revealed five themes representative of the core disclosure challenges parents encountered, many of which promoted concealment and/or selective disclosure, namely: seeking normalcy for the child, the invisibility of epilepsy, negative reactions to disclosure, contending with poor public perceptions of epilepsy and coming to terms with the diagnosis. Discussion This study presents crucial information for healthcare professionals (HCPs) who help families to navigate the disclosure decision-making process. Providing HCPs working with families living with epilepsy with insight into diagnosis disclosure challenges will enable them to recognise the support needs of parents and work collaboratively with families to tackle such difficulties, ultimately improving their psychosocial wellbeing.

Recommendations of Common Data Elements to Advance the Science of Self-Management of Chronic Conditions.

PURPOSE: Common data elements (CDEs) are increasingly being used by researchers to promote data sharing across studies. The purposes of this article are to (a) describe the theoretical, conceptual, and definition issues in the development of a set of CDEs for research addressing self-management of chronic conditions; (b) propose an initial set of CDEs and their measures to advance the science of self-management; and (c) recommend implications for future research and dissemination. DESIGN AND METHODS: Between July 2014 and December 2015 the directors of the National Institute of Nursing Research (NINR)-funded P20 and P30 centers of excellence and NINR staff met in a series of telephone calls and a face-to-face NINR-sponsored meeting to select a set of recommended CDEs to be used in self-management research. A list of potential CDEs was developed from examination of common constructs in current self-management frameworks, as well as identification of variables frequently used in studies conducted in the centers of excellence. FINDINGS: The recommended CDEs include measures of three self-management processes: activation, self-regulation, and self-efficacy for managing chronic conditions, and one measure of a self-management outcome, global health. CONCLUSIONS: The self-management of chronic conditions, which encompasses a considerable number of processes, behaviors, and outcomes across a broad range of chronic conditions, presents several challenges in the identification of a parsimonious set of CDEs. This initial list of recommended CDEs for use in self-management research is provisional in that it is expected that over time it will be refined. Comment and recommended revisions are sought from the research and practice communities. CLINICAL RELEVANCE: The use of CDEs can facilitate generalizability of research findings across diverse population and interventions.

The stigma experiences and perceptions of families living with epilepsy: Implications for epilepsy-related communication within and external to the family unit.

OBJECTIVE: This paper presents the stigma experiences of children with epilepsy (CWE) and their parents and outlines the relationship between CWE's and parents' stigma perceptions, demographic and seizure variables, and epilepsy-related communication within and external to the family. METHODS: A mixed-method design was employed. In phase one, 33 CWE and 40 parents participated in qualitative interviews. In phase two, 47 CWE and 72 parents completed a cross-sectional survey. RESULTS: CWE and their parents experience felt and enacted stigma via social exclusion, activity restriction, teasing/bullying, internalised negative feelings to epilepsy, concealment of epilepsy and parental stigma-coaching. Higher CWE and parent stigma perceptions were significantly correlated with greater epilepsy concealment from others outside the family and greater negative affect around epilepsy-related communication within the home. CONCLUSION: As CWE and their parents grapple with epilepsy-related stigma they may inadvertently contribute to the silence encircling epilepsy through diagnosis concealment, stigma-coaching and/or by engaging in limited family dialogue about epilepsy. PRACTICE IMPLICATIONS: Healthcare professionals need to be cognisant of broaching the sensitive topic of epilepsy-related stigma during their engagements with families living with epilepsy. Assisting families to appropriately engage in dialogue surrounding epilepsy is likely to improve the psychosocial wellbeing of CWE and their parents.

Talking about epilepsy: Challenges parents face when communicating with their child about epilepsy and epilepsy-related issues.

The aim of this qualitative study was to explore the challenges that parents of children with epilepsy experienced when engaging in dialog with their child about epilepsy and epilepsy-related issues. Using a qualitative exploratory approach, interviews were conducted with 34 parents of children with epilepsy (aged 6-16 years), consisting of 27 mothers and 7 fathers. Data were transcribed verbatim and thematically analyzed. Findings revealed five main themes: normalizing epilepsy, the invisibility of epilepsy, information concealment, fear of misinforming the child, and difficulty in discussing particular epilepsy-related issues. Many of the communicative challenges experienced by parents impacted on their ability to engage openly in parent-child dialog about epilepsy in the home. Parents face specific challenges when choosing to communicate with their child about epilepsy, relating to creating a sense of normality, reducing fear of causing their child worry, and having a lack of epilepsy-related knowledge. Healthcare professionals who work closely with families living with epilepsy should remain mindful of the importance of discussing family communication surrounding epilepsy and the challenges parents of children with epilepsy face when talking about epilepsy within the home.

Telephone Assessment and Skill-Building Kit for Stroke Caregivers: A Randomized Controlled Clinical Trial.

BACKGROUND AND PURPOSE: There are few evidence-based programs for stroke family caregivers postdischarge. The purpose of this study was to evaluate efficacy of the Telephone Assessment and Skill-Building Kit (TASK II), a nurse-led intervention enabling caregivers to build skills based on assessment of their own needs. METHODS: A total of 254 stroke caregivers (primarily female TASK II/information, support, and referral 78.0%/78.6%; white 70.7%/72.1%; about half spouses 48.4%/46.6%) were randomized to the TASK II intervention (n=123) or to an information, support, and referral group (n=131). Both groups received 8 weekly telephone sessions, with a booster at 12 weeks. General linear models with repeated measures tested efficacy, controlling for patient hospital days and call minutes. Prespecified 8-week primary outcomes were depressive symptoms (with Patient Health Questionnaire Depressive Symptom Scale PHQ-9 ≥5), life changes, and unhealthy days. RESULTS: Among caregivers with baseline PHQ-9 ≥5, those randomized to the TASK II intervention had a greater reduction in depressive symptoms from baseline to 8, 24, and 52 weeks and greater improvement in life changes from baseline to 12 weeks compared with the information, support, and referral group (P<0.05); but not found for the total sample. Although not sustained at 12, 24, or 52 weeks, caregivers randomized to the TASK II intervention had a relatively greater reduction in unhealthy days from baseline to 8 weeks (P<0.05). CONCLUSIONS: The TASK II intervention reduced depressive symptoms and improved life changes for caregivers with mild to severe depressive symptoms. The TASK II intervention reduced unhealthy days for the total sample, although not sustained over the long term. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01275495.