Younger Caregivers Research Articles

Navigating Both Roles: A Photovoice Exploration of the Young Adult Balancing Daughterhood and Caregiving for a Mother With Young-Onset Dementia.

Young adults thrust into the role of caregiving for parents with young-onset dementia (YOD) face unique challenges during their formative years. While existing research acknowledges the crucial role of young adult caregivers, a gap persists in understanding how this group experiences and redefines their identity amidst these circumstances, along with the psychological and societal challenges encountered. This knowledge deficit hinders the identification of suitable social support, adversely affecting the personal growth and well-being of these young adult caregivers. In this single-case study, we used a combination of a semi-structured interview and photovoice to explore the journey of a 19-year-old caregiver, Alice, whose mother had been diagnosed with dementia in the preceding 3 years. Through this unique perspective, we aimed to illuminate how caregiving for a mother with YOD may profoundly redefine familial roles and relationships. Over 3 months, Alice captured significant life moments through photography, selecting meaningful images for bi-weekly meetings. These images served as pivotal themes, triggering in-depth conversations during subsequent interviews to provide nuanced insights into her life experiences. Findings reveal four major themes faced by a young caregiver: (1) challenges adapting to an unexpected role, (2) navigating the complex emotional terrain of losing a loved one to YOD, (3) prioritizing the well-being of the healthy parent, and (4) expressing a profound desire for both informal and formal support. These results underscore the intricate identity and emotional challenges faced by young adult caregivers, emphasizing the urgency of addressing their unique needs through family-centered systemic support services.

'You can be as vigilant as you can, yet they make their way in': A descriptive study of parent and caregiver perspectives towards keeping children safe from button batteries.

Button batteries pose a significant threat to young children, and parents and caregivers play an important role in keeping children safe from button batteries, especially in the home environment. However, little is known regarding parent or caregiver perspectives on button battery safety, in particular, the threat they pose to children. The aim of this study was to examine perspectives on button battery safety to enable tailored prevention strategies and to examine parent and caregiver perspectives on button battery safety in the home. One hundred and seventy-four parents and caregivers of children aged 0-5 completed a cross-sectional online survey. Distribution occurred via social media. The survey contained multiple-choice questions pertaining to button battery knowledge and attitudes. Most respondents recognised the dangers of button battery ingestion, yet only 37% knew of button battery ingestion symptoms. While 68% knew of household items containing button batteries, 21% were aware of product-recall information sources. Approximately 64% understood immediate post-ingestion steps, but only 31% were familiar with first-aid procedures. From an attitudinal standpoint, 95% understood the importance of child supervision around button batteries, 78% prioritised battery safety in toy purchases, and 17% found current safety labels unsatisfactory. This study provides a foundation for ongoing investigation of parent and caregiver perspectives on button battery home safety. Ongoing, comprehensive education and public-safety campaigns are needed to rectify gaps in knowledge regarding button battery safety, and to reduce the risk of button battery ingestion in children.

Young caregivers and COVID-19: a care-full approach through (post-)qualitative enquiry

Young caregivers and COVID-19: a care-full approach through (post-)qualitative enquiry

Youth Caregivers of Adults in the United States: Prevalence and the Association Between Caregiving and Education

A growing proportion of individuals adopt family caregiving roles. Family caregivers are the primary providers of long-term care in the United States yet limited federal policy supports exist, despite the known negative impacts of caregiving. There is also limited information about the prevalence of youth/young adult caregivers and the impacts of caregiving at formative ages in the United States. Our objective is to estimate the prevalence of youth caregivers and examine the association of caregiving with educational investments. We use the American Time Use Survey (2013–2019) to identify and describe youth caregivers (aged 15–18) and young adult caregivers (aged 19–22) and compare them with non-caregiving peers. We estimate that there are approximately 1,623,000 youth caregivers and 1,986,000 young adult caregivers, corresponding to 9.2% and 12.7% of these age groups, respectively. However, there is a wide range in the estimated prevalence per year, from approximately 364,000 to 2.8 million youth caregivers and from 353,000 to 2.2 million young adult caregivers, depending on caregiver definition. Unlike adult caregivers, we find that young men and women were nearly equally likely to provide care. We also find that non-White individuals are disproportionately represented as youth caregivers. Compared with non-caregiving peers, both youth and young adult caregivers are less likely to be enrolled in school and, among those enrolled in school, spend significantly less time on educational activities. Considering the association of caregiving among youth/young adults and education, policies supporting youth and young adult caregivers are critical.

PCR253 Knowledge, Attitude, and Practices (KAP) Regarding Vaccination Against Human Papillomavirus (HPV) Among Young People, Caregivers, and Healthcare Professionals (HCPs)

PCR253 Knowledge, Attitude, and Practices (KAP) Regarding Vaccination Against Human Papillomavirus (HPV) Among Young People, Caregivers, and Healthcare Professionals (HCPs)

Perceived helpfulness of caregiver support resources: Results from a state-wide poll

ObjectiveOur goal was to identify specific types of services desired by caregivers and determine subgroups most interested in each service type. MethodsCaregiving questions were added to a state-wide poll conducted in a majority-rural state. Those who identified as caregivers (n = 428) were asked to report on the helpfulness of 6 domains of services. Descriptive analysis and logistic regressions were conducted. ResultsTop resources caregivers identified as potentially helpful included hands-on services (33.9%), help coordinating care from multiple providers (21.5%), help with finances (18.9%), and help managing emotional stress (17.8%). Only 15% indicated no caregiver resources would be helpful. Younger caregivers endorsed several service domains as more helpful than older caregivers; caregivers reporting higher stress were more likely to endorse most domains as helpful. ConclusionData reinforces the overwhelming need to offer caregiver services. Navigation and integrated and tailored service models may be beneficial to help caregivers identify and access appropriate services within healthcare systems. InnovationThis study uses an innovative approach to identifying needs of caregivers, who are often invisible within the healthcare system. Our findings suggest a paradigm shift is needed to broaden the scope and depth of services offered to caregivers.

Caregiver Burden for Carers of Chronically Mentally Ill Patients: A Study With Families in Cyprus

Having a chronically mentally ill person in the family presents a challenge for the entire family system, not only on a daily life basis but also regarding their psycho-emotional and social life. The present study focuses on caregivers of chronically ill patients' burden on four levels of possible disruption: the economic burden, the impact on family life, sociability, health, and behavior, and the impact of perceived aggression by considering the demographic characteristics of the caregivers, but also the socio-demographic characteristics of the chronically ill family member(s) they are taking care of. We conducted a quantitative survey with a sample of 90 family members/caregivers and the corresponding 90 chronically ill patients under their care from all districts of the Republic of Cyprus. Participants completed the "Family Burden Scale" (FBS-23) (Madianos et al., 2004), a personal information form with demographic information, and a questionnaire regarding the demographics and the illness trajectory of the chronically mentally ill family member (age of disease onset, diagnosis, frequency of episodes). Our findings showed that most caregivers providing systematic care for a family member experienced high levels of disruption in their daily routine and sociability, perceived high levels of aggressive behaviors, felt moderately affected in their health and behavior, and carried a heavy economic burden. Older participants felt a significantly higher economic burden than younger caregivers, who perceived a significantly more significant negative impact on their health and behavior from taking care of a chronically ill family member.

Information needs of caregivers of adults with intellectual and/or developmental disabilities in India.

Many families of adults with intellectual and/or developmental disabilities in India experience difficulty in accessing services/supports, due to lack of awareness/knowledge of disability rights/laws and available services, and in accessing the services. There remains insufficient research on the information needs of these caregivers and on designing interventions that aim to increase their awareness/knowledge about human rights and supports/services. A strengths-based mixed methods needs assessment was conducted to understand the information needs of these family caregivers. Results showed that caregivers ≥50 years had significantly higher information needs than younger caregivers. Specifically, caregivers with no proficiency in English needed more information on the available services for the care recipients (n = 100). Qualitative results showed that very few caregivers had any awareness or access to information on human rights, disability-related laws/policies or available supports/services (n = 15). Study findings underscore the government's role in improving awareness-raising initiatives and imparting the information in multiple Indian languages.

Understanding caregiver burden and quality of life in Kerala’s primary palliative care program: a mixed methods study from caregivers and providers’ perspectives

BackgroundFamily caregivers are vital for long-term care for persons with serious health-related suffering in Kerala. Long-term caregiving and ageing may become burdensome and detrimental to patients and caregivers. We compared the caregiver burden and quality-of-life of ageing caregivers with younger caregivers. We also explored the palliative care nurses’ perceptions of the family caregivers’ issues.MethodsWe did a mixed method study focusing on two groups: (i) three in-depth interviews and a cross-sectional survey among 221 caregivers of palliative care patients in five randomly selected panchayats (most peripheral tier of three-tier local self-government system in India concerned with governance of a village or small town) of Kollam district, Kerala, as part of development and validation of the Achutha Menon Centre Caregiver Burden Inventory; (ii) five in-depth interviews with purposively selected primary palliative care nurses as part of a study on local governments and palliative care. We used a structured interview schedule to collect cross-sectional data on sociodemographic and caregiving-related characteristics, caregiver burden, and health-related quality of life using the EuroQol EQ5D5L and interview guidelines on caregiver issues tailored based on participant type for qualitative interviews.ResultsOlder caregivers comprised 28.1% of the sample and had significantly poorer health and quality-of-life attributes. More senior caregivers experiencing caregiver burden had the lowest mean scores of 0.877 (Standard deviation (SD 0.066, 95% confidence intervals (CI) 0.854–0.899) followed by younger caregivers with high burden (0.926, SD 0.090, 95% CI 0.907–0.945), older caregivers with low burden (0.935, SD 0.058, 95% CI 0.912–0.958) and younger caregivers with low burden (0.980, SD 0.041, 95% CI 0.970–0.990). Caregivers faced physical, psychological, social, and financial issues, leading to a caregiver burden. The relationships between the palliative care nurses and family caregivers were complex, and nurses perceived caregiver burden, but there were no specific interventions to address this.ConclusionIn our study from Kollam, Kerala, three out of ten caregivers of palliative care patients were 60 years of age or older. They had significantly lower health-related quality of life, particularly if they perceived caregiver burden. Despite being recognized by palliative care nurses, caregiver issues were not systematically addressed. Further research and suitable interventions must be developed to target such problems in the palliative care programme in Kerala.

Estimating additional health and social costs in eating disorder care for young people during the COVID-19 pandemic: implications for surveillance and system transformation

BackgroundThe impact of the COVID-19 pandemic on young people with eating disorders (EDs) and their families was profound, with surging rates of hospitalizations and referrals reported internationally. This paper provides an account of the additional health and social costs of ED care for young people living in Canada incurred during the COVID-19 pandemic, drawing attention to the available data to inform these estimates while noting gaps in data capacities to account for a full view of the ED system of care.MethodsThree methodologies were used to capture costs: (1) provincial administrative data holdings available at the Canadian Institute of Health Information (CIHI) were used by Deloitte Access Economics to conduct analyses on costs related to hospitalizations, emergency room visits, outpatient visits with physicians and loss of well-being from being on a waitlist. These were examined across three fiscal years (April 1 to March 31, 2019–2022) to compare costs from one year before to two years after the onset of the pandemic, (2) data collected on support-based community ED organizations and, (3) costs identified by young people, caregivers and health care professionals.ResultsEstimates of additional health care costs and social costs arising from ED care waitlists were estimated to have increased by 21% across the two years after the onset of the pandemic and is likely to represent an underestimate of costs. Costs related to some standard ED care services (e.g. day treatment programs) and support-based community ED organizations that saw a 118% increase in services during this time, are some examples of costs not captured in the current cost estimate.ConclusionsThis paper provides a first account of the additional health and social ED care costs associated with the pandemic, which indicate at minimum, a 21% increase. The results invite discussion for more investments in ED services for young people in Canada, as it is unclear if needs are expected to remain elevated. We suggest a call for a national surveillance strategy to improve data holdings to aid in managing services and informing policy. A robust strategy could open the door for much-needed, data-informed, system transformation efforts that can improve ED care for youth, families and clinicians.

Receipt of seasonal malaria chemoprevention by age-ineligible children and associated factors in nine implementation states in Nigeria

BackgroundAs part of implementation quality standards, community distributors are expected to ensure that only age-eligible children (aged 3–59 months) receive seasonal malaria chemoprevention (SMC) medicines during monthly campaigns. There is uncertainty about the extent to which SMC medicines are administered to ineligible children. This study aimed to assess the magnitude of this occurrence, while exploring the factors associated with it across nine states where SMC was delivered in Nigeria during the 2022 round.MethodsThis analysis was based on data from representative end-of-round SMC household surveys conducted in nine SMC-implementing states in Nigeria. Data of 3299 age-ineligible children aged > 5 years and their caregivers were extracted from the survey dataset. Prevalence of receipt of SMC medicines by ineligible children was described by child-, caregiver- and SMC-related factors. Mixed-effects multivariable logistic regression models were fitted to explore the factors associated with ineligible receipt of SMC medicines.Results30.30% (95% CI 27.80–32.90) of ineligible children sampled received at least one dose of SMC medicines in 2022, the majority (60.60%) of whom were aged 5–6 years while the rest were aged 7–10 years. There were lower odds of an age-ineligible child receiving SMC medicines among caregivers who were knowledgeable of SMC age eligibility (OR: 0.53, 95% CI 0.37–0.77, p < 0.001), compared with those who were not knowledgeable of age eligibility. Higher odds of receipt of SMC were found among age-ineligible children whose caregivers had higher confidence in the protective effect of SMC against malaria (OR: 2.01, 95% CI 1.07–3.72, p = 0.030), compared with those whose caregivers were less confident. Compared with ineligible children of younger caregivers (aged < 20 years), those whose caregivers were older had lower odds of receiving SMC than those whose caregivers were younger; with lower odds among children of caregivers aged 20–39 years (OR: 0.50, 95% CI 0.30–0.82, p = 0.006).ConclusionsThis study contributes important evidence on the magnitude of the receipt of SMC medicines by age-ineligible children, while identifying individual and contextual factors associated with it. The findings provide potentially useful insights that can help inform and guide context-specific SMC implementation quality improvement efforts.

Effective Relationships Between Younger Caregivers and Older Care Recipients Across a Continuum of Formal Residential Care Settings: A Scoping Review and a Critical Analysis.

Objective: This article aims to conduct a scoping review of what constitutes effective relational interactions between caregivers (CGs) and older persons (OPs) across formal residential care settings. Methods: A scoping review of publications between January 2000 and December 2021 yielded 10,929 articles, and after removing duplicates and applying exclusion criteria, 36 articles were analysed. Results: Articles were scrutinised for interactions involving both CGs and OPs, using a thematic framework analysis to identify effective relational constructs. Four themes emerged: 1) Diverse perspectives on the same context: for OPs it is home, and for CGs, workplace. 2) CGs move for a one-up position and OPs submit to a one-down, or as friends. 3) Relational qualities have been mostly associated with CGs, confirming care as a unidirectional action 4). Relationships between CGs and OPs result either in effective or ineffective care outcomes. Conclusion: The dual meanings attached to the same context limit the authentic interactions between CGs and OPs. We propose a relational caregiving approach by considering the interactions of both CGs and OPs, changing the relational definition, and demonstrating effective relational qualities.

A mixed-method systematic review of the perspectives of young people, carers and professionals on psychiatric diagnosis in childhood and adolescence.

The significance and complexities of a psychiatric diagnosis have been well-documented in existing literature. Despite the reliability and accuracy of such diagnoses, the impact and use of diagnostic labelling on young people remains unclear. A systematic review was conducted using six databases, identifying 13 studies that explored psychiatric diagnosis experiences in professionals, caregivers, and young people. This review focuses on three main themes related to psychiatric diagnosis in young people. The first theme is diagnostic subjectivity, which explores the accuracy, usefulness, potential harm and alternatives (e.g. psychological formulation) to psychiatric diagnosis in this population. The second theme is the utility of psychiatric diagnosis, which considers whether it helps young people access appropriate support and gain a better understanding of themselves and their presenting issues. The third theme is stigma, which examines the negative experiences and discrimination that young people may face due to their psychiatric diagnosis. There is relatively limited literature which discusses the experience of psychiatric diagnosis in young people, caregivers and professionals. The available literature is difficult to compare due to discrepancies between methodologies and services, and there are several gaps i.e. a limited focus on the experience of young people themselves. Different views and experiences of psychiatric diagnosis among professionals, caregivers, and young people could impact young people's quality of life, access to healthcare, and identity development. The current literature needs to be more comprehensive to draw firm conclusions about young people's experiences with psychiatric diagnosis.

Association of filial attitude, filial behavior and death literacy: implications for development of death system in Guangdong-Hong Kong-Macao Greater Bay Area of China

BackgroundFilial piety, as a major traditional norm in Chinese culture and in Chinese families, affects the attitudes and behaviors of adult children toward their parents and impacts their end-of-life decision-making and the quality of death of their parents. Death literacy is a novel concept aimed at promoting palliative care in the context of public health.AimsTo understand attitudes and behaviors related to filial piety and to examine the role of death literacy in filial behaviors toward dying parents among residents in the Guangdong-Hong Kong-Macao Greater Bay Area of China.MethodsA cross-sectional online survey that employed the convenient and snowball sampling methods was adopted. Filial Piety Representations at Parents’ End of Life Scale and Death Literacy Index were used.ResultsThis study identified a significant gap between the filial piety attitudes and behaviors of Chinese adult children. Gender, caregiving experience and death literacy were predictors of filial behaviors in an end-of-life context.ConclusionProviding truth disclosure support, offering guidance to young adult children and caregivers of terminally ill fathers, and strengthening factual and community knowledge of death are necessary to enhance the reciprocal comfort of both adult children and dying parents in the context of Chinese filiality.

Burden and quality of life of family caregivers of Alzheimer’s disease patients: the role of forgiveness as a coping strategy

Objectives This study aimed to evaluate the variables that were associated, contributed and moderated quality of life (QoL) and burden in family caregivers. Methods A total of 130 participants were evaluated using the following instruments: Depression, Anxiety and Distress Scale; Index of Family Relations; Heartland Forgiveness Scale; Burden Interview Scale; Short Form Health Survey. Results Being a younger caregiver, less distress, better family relationships and greater use of forgiveness were associated with more QoL. Also, family caregivers who chosethe caregiving role, less distress, better family relationships and greater use of forgiveness showed lower levels of burden. Age, distress and forgiveness contributed to QoL. In turn, the choice to become a family caregiver, distress, and forgiveness contributed to burden. Forgiveness played a moderating role in the relationship between family relationships and burden. Conclusion Based on the results, there is a need to intervene in older family caregivers, particularly those who did not choose to become a caregiver, who report greater distress, have worse family relationships, and display less use of forgiveness, in order to decrease their burden and promote QoL.

Impact of age and comorbid heart failure on the utility of smart voice-assistant devices.

The accuracy of voice-assisted technologies, such as Amazon Alexa, to collect data in patients who are older or have heart failure (HF) is unknown. The aim of this study is to analyse the impact of increasing age and comorbid HF, when compared with younger participants and caregivers, and how these different subgroups classify their experience using a voice-assistant device, for screening purposes. Subgroup analysis (HF vs. caregivers and younger vs. older participants) of the VOICE-COVID-II trial, a randomized controlled study where participants were assigned with subsequent crossover to receive a SARS-CoV2 screening questionnaire by Amazon Alexa or a healthcare personnel. Overall concordance between the two methods was compared using unweighted kappa scores and percentage of agreement. From the 52 participants included, the median age was 51 (34-65) years and 21 (40%) were HF patients. The HF subgroup showed a significantly lower percentage of agreement compared with caregivers (95% vs. 99%, P = 0.03), and both the HF and older subgroups tended to have lower unweighted kappa scores than their counterparts. In a post-screening survey, both the HF and older subgroups were less acquainted and found the voice-assistant device more difficult to use compared with caregivers and younger individuals. This subgroup analysis highlights important differences in the performance of a voice-assistant-based technology in an older and comorbid HF population. Younger individuals and caregivers, serving as facilitators, have the potential to bridge the gap and enhance the integration of these technologies into clinical practice. ClinicalTrials.gov Identifier: NCT04508972.

Exploring the Lived Experiences of Caregiving for Older Family Members by Young Caregivers in Singapore: Transition, Trials, and Tribulations.

Amidst population ageing trends and epidemiological transitions, there has been a growing emergence of young family caregivers, about whom most studies have been conducted in Western countries. Their subjective experiences and perceptions toward caregiving remain underexplored in Asia. This qualitative study explored the lived experiences of caregiving for older family members by young caregivers in Singapore. Interpretative phenomenological analysis was employed to collect and analyse data from semi-structured, in-depth interviews with six young adult caregivers aged between 23 and 29. Interviews were supplemented with photo-elicitation techniques to deepen interview discussions and uncover experiential significance. Findings illustrated transitions into caregiving, challenges across role conflicts and expectations amidst developmental tasks and transitions, and navigation of intergenerational conflicts and ambivalence. Although no definitive conclusions can be reached from this small-scale study, the findings offer important insights into the convergence and intensity of young caregivers' experiences. Given that caregiving challenges are likely to continue amidst Singapore's rapidly ageing population, these necessitate further in-depth research efforts. Implications for policy and practice across multiple stakeholders interfacing with youth and older adults are presented. A whole-of-society approach is called for to enable young caregivers to realise their full potential while contributing to their ageing families and nation.

Misalignment of social support in the social media posts of young adult cancer caregivers.

Compared with older cancer caregivers, young adult cancer caregivers (YACC) experience greater stress and depression during the first 6 months of caregiving. Social support can buffer the negative psychological effects associated with cancer caregiving. However, the misalignment of social support is associated with increased distress and worse emotional well-being. As YACC are more likely to utilize social media (SM) to seek social support compared with older cancer caregivers, they may be at greater risk of experiencing the misalignment of social support and related negative outcomes. The purpose of this study was to identify ways that SM posts containing support for YACC's were potentially misaligned with the social support desired by YACC. In this secondary analysis, cancer-related SM posts (N = 760) from 34 YACC's SM accounts were extracted for 6 months following the day of cancer diagnosis and imported into NVivo qualitative analysis software. Open coding of posts from four YACC identified a pattern of SM posts containing responses that may misalign with social support requests, and could be perceived as dismissive of YACC's emotions. Similar posts were grouped together, forming categories which were used to create a codebook and applied in coding all posts from the remaining 30 YACC. Content analysis identified three categories of social support misalignment originating from YACC's SM posts: supplications (n = 251, 33%), prevailing (n = 7, 10.1%), and consolations (n = 16, 2.1%). Supplications involved prayer or trust in god, prevailing posts compared dealing with cancer to a fight and suggested that the person would overcome cancer, and consolations used quotes, song lyrics, and or general reassurances in SM posts. Findings suggest that when YACC use SM during cancer experiences, they may interpret SM posts as social support or as misalignment of social support requests, which in turn can lead to either improved quality of life or additional distress (respectively). This study adds to the body of knowledge regarding how YACC use social media for social support and may inform future interventions designed to match YACC's desired support with support offered.

Navigating antenatal care: The lived experiences of adolescent girls and young women and caregiver perspectives in Zambia.

Adolescent pregnancy remains a global concern, especially in low- and middle-income countries. Sub-Saharan African nations, including Zambia, bear a disproportionate burden of adolescent pregnancies, contributing to high rates of maternal and child mortality. Despite efforts to improve antenatal care (ANC) services, utilization rates remain suboptimal, especially among adolescent girls and young women (AGYW). To explore the barriers and facilitators to ANC services among AGYW and how these factors might differ by age and HIV status. This qualitative study employs a combination of in-depth interviews (IDIs) and focus group discussions (FGDs) to gather comprehensive insights into the experiences of AGYW regarding ANC services. The study design follows a socio-ecological framework (SEF) to identify multiple levels of influence on ANC utilization. We conducted 40 IDIs with AGYW aged 15-24; and 2 FGDs with caregivers of AGYW (n = 16). IDIs explored AGYWs barriers and facilitators to accessing and utilizing healthcare services during pregnancy, as well as social support and HIV treatment and prevention. FGD topics included social support, barriers and facilitators to ANC, and HIV services. We developed a codebook based on the SEF and coded transcripts using Dedoose software. Results showed that early pregnancy knowledge did not always translate to AGYW seeking ANC services right away or within the first trimester. More than half of the AGYW did not initiate ANC until well into the second trimester. Factors including lack of motivation, denial of pregnancy, desires to terminate pregnancies, social norms, policies, clinic environment, and financial constraints contributed to delays in ANC initiation. Social support from family, partners, peers, and the community were crucial motivators for early ANC. Lastly, challenges to ANC continuation included lack of transportation, long clinic waiting times, perceived provider indifference, and stigma at both community and clinic levels. In conclusion, gaining insights from qualitative data is essential for comprehensively understanding the barriers and challenges to accessing ANC among this specific age group. By identifying and addressing these barriers while enhancing facilitators, effective programs can be developed and implemented to improve the health and well-being of young mothers and their children.

Guidelines for reporting pediatric and child health clinical trial protocols and reports: study protocol for SPIRIT-Children and CONSORT-Children

BackgroundDespite the critical importance of clinical trials to provide evidence about the effects of intervention for children and youth, a paucity of published high-quality pediatric clinical trials persists. Sub-optimal reporting of key trial elements necessary to critically appraise and synthesize findings is prevalent. To harmonize and provide guidance for reporting in pediatric controlled clinical trial protocols and reports, reporting guideline extensions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) guidelines specific to pediatrics are being developed: SPIRIT-Children (SPIRIT-C) and CONSORT-Children (CONSORT-C).MethodsThe development of SPIRIT-C/CONSORT-C will be informed by the Enhancing the Quality and Transparency of Health Research Quality (EQUATOR) method for reporting guideline development in the following stages: (1) generation of a preliminary list of candidate items, informed by (a) items developed during initial development efforts and child relevant items from recent published SPIRIT and CONSORT extensions; (b) two systematic reviews and environmental scan of the literature; (c) workshops with young people; (2) an international Delphi study, where a wide range of panelists will vote on the inclusion or exclusion of candidate items on a nine-point Likert scale; (3) a consensus meeting to discuss items that have not reached consensus in the Delphi study and to “lock” the checklist items; (4) pilot testing of items and definitions to ensure that they are understandable, useful, and applicable; and (5) a final project meeting to discuss each item in the context of pilot test results. Key partners, including young people (ages 12–24 years) and family caregivers (e.g., parents) with lived experiences with pediatric clinical trials, and individuals with expertise and involvement in pediatric trials will be involved throughout the project. SPIRIT-C/CONSORT-C will be disseminated through publications, academic conferences, and endorsement by pediatric journals and relevant research networks and organizations.DiscussionSPIRIT/CONSORT-C may serve as resources to facilitate comprehensive reporting needed to understand pediatric clinical trial protocols and reports, which may improve transparency within pediatric clinical trials and reduce research waste.Trial RegistrationThe development of these reporting guidelines is registered with the EQUATOR Network: SPIRIT-Children (https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials-protocols/#35) and CONSORT-Children (https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#CHILD).