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BACKGROUND: Food allergy (FA) impairs psychological wellbeing because of constant vigilance, planning and preparation, dietary and social restrictions, and fear of accidental ingestion, though psychological interventions are sparse. OBJECTIVE: To examine online, group, low-intensity psychological interventions for adults, children, young people (CYP), and parents with food allergies. METHODS: The randomized controlled trials assessed the feasibility and signal of the efficacy of a psychological intervention for adults, CYP, and parents with FA. Participants were randomized to receive the psychological intervention or treatment as usual. The intervention consisted of two, 3-hour manualized online sessions spaced 1 week apart. All participants completed relevant Food Allergy Quality of Life Questionnaires (FAQLQ) and worry (Penn State Worry Questionnaires), in addition to exploratory outcomes, at baseline, 1 month, and 3 months. RESULTS: A total of 129 participants (n = 44 adults, n = 52 CYP, and n = 33 parents) were recruited and randomized; 95 (74%) (n = 36 adults, n = 35 CYP, and n = 24 parents) were retained at 3 months. Owing to baseline differences, mean change was used for parent and CYP outcomes. The psychological intervention demonstrated large FAQLQ benefits across adults (g = -1.12, 95% CI -0.41 to -1.28), CYP (g = 1.23, 95% CI 0.51-1.95), and parents (g = 1.43, 95% CI 0.54-2.30) compared with controls at 3-months. CONCLUSION: This study provides encouraging findings regarding the feasibility of online, group, low-intensity psychological interventions, in terms of recruitment and retention as well as a signal of efficacy on FAQLQ. A definitive trial including health economic analysis and FA-specific psychological measures with consideration of best routes to implementation, is warranted. TRIAL REGISTRATION: Clinicaltrials.gov Identifiers: NCT04763889 (adults), NCT04770727 (CYP), and NCT04774796 (parents).
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Rumination is an established transdiagnostic factor in mental illness, but there remains a significant gap in understanding the subjective experiences of those affected by it. This study explored the lived experiences of depressive rumination in early adulthood, a population notably susceptible to its effects. We interviewed 20 participants aged between 18 and 35 years using a semistructured approach and generated five distinct but interconnected themes using reflective thematic analysis. The first theme delved into recurrent narratives of past traumas and unresolved pain, with participants unable to move on from their past. The second theme illustrated how participants, due to real or perceived pressure, often equated their self-worth with their ability to meet expectations, leading to a distorted self-view and diminished self-esteem. The third theme captured the relentless pursuit of mental peace, with tranquility remaining ever elusive despite the frequent use of distraction. The fourth theme highlighted the profound isolation stemming from internalized mental health stigma, with participants grappling with fears of being perceived as burdensome and facing rejection from their close ones. Finally, the fifth theme underscored the far-reaching and interconnected repercussions of rumination on mental, emotional, and physical health and individuals' ability to achieve their life goals. These findings emphasize the intertwined nature of psychological, physiological, and social risk factors for the development and maintenance of rumination, advocating for a holistic treatment approach to rumination and paving the way for more timely, tailored care. (PsycInfo Database Record (c) 2024 APA, all rights reserved).
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Ruminação Cognitiva , Autoimagem , Humanos , Adulto , Feminino , Masculino , Adulto Jovem , Adolescente , Depressão/psicologia , Pesquisa Qualitativa , Estigma SocialRESUMO
BACKGROUND: IgE-mediated food allergy (FA) is a global health concern with substantial individual and societal implications. While diverse intervention strategies have been researched, inconsistencies in reported outcomes limit evaluations of FA treatments. To streamline evaluations and promote consistent reporting, the Core Outcome Measures for Food Allergy (COMFA) initiative aimed to establish a Core Outcome Set (COS) for FA clinical trials and observational studies of interventions. METHODS: The project involved a review of published clinical trials, trial protocols and qualitative literature. Outcomes found as a result of review were categorized and classified, informing a two-round online-modified Delphi process followed by hybrid consensus meeting to finalize the COS. RESULTS: The literature review, taxonomy mapping and iterative discussions with diverse COMFA group yielded an initial list of 39 outcomes. The iterative online and in-person meetings reduced the list to 13 outcomes for voting in the formal Delphi process. One more outcome was added based on participant suggestions after the first Delphi round. A total of 778 participants from 52 countries participated, with 442 participating in both Delphi rounds. No outcome met a priori criteria for inclusion, and one was excluded as a result of the Delphi. Thirteen outcomes were brought to the hybrid consensus meeting as a result of Delphi and two outcomes, 'allergic symptoms' and 'quality of life' achieved consensus for inclusion as 'core' outcomes. CONCLUSION: In addition to the mandatory reporting of adverse events for FA clinical trials or observational studies of interventions, allergic symptoms and quality of life should be measured as core outcomes. Future work by COMFA will define how best to measure these core outcomes.
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Hipersensibilidade Alimentar , Qualidade de Vida , Humanos , Técnica Delphi , Hipersensibilidade Alimentar/diagnóstico , Hipersensibilidade Alimentar/terapia , Imunoglobulina E , Avaliação de Resultados em Cuidados de Saúde , Projetos de Pesquisa , Resultado do Tratamento , Ensaios Clínicos como Assunto , Estudos Observacionais como AssuntoRESUMO
This systematic review aimed to review the evidence for psychological support for children with food allergies and their families, identify effective psychological interventions, and highlight the support needs for this group. A systematic search was undertaken across six databases (up to October 2023). Articles were checked by three reviewers for inclusion. Study data were extracted, and quality was assessed using the Mixed Methods Appraisal Tool. A narrative synthesis was undertaken. A total of 11 papers were included (n = 838 participants). Intervention types were based on cognitive behavioral therapy (CBT; n = 7); psycho-education (n = 1); peer mentoring (n = 1); self-regulation theory (n = 1); and coping (n = 1). Two interventions were for children only, three were for children and parents and six for parents only. Cognitive behavioral therapy-based interventions with highly anxious parents or children or those facilitated by a psychologist showed significant improvements with moderate-to-large effect sizes. The one self-help CBT-based online program showed no effects. Other intervention types reported mainly trends in improvement due to small sample sizes. Most interventions were aimed at supporting children or parents in day-to-day management of food allergy, measuring outcomes such as quality of life, self-efficacy, anxiety, worry, and depression. One intervention was designed to assist with oral immunotherapy outcomes. The majority of the studies had small sample sizes and were feasibility or proof-of-concept studies. Available research evidence points to effectiveness of facilitated CBT-based interventions for those that have high food allergy-related anxiety, but as many studies have small sample sizes and few report effect sizes, no firm conclusions can yet be drawn. A stepped care approach is likely to be useful for this population. Research using large interventional designs, particularly for children and adolescents, are needed.
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Terapia Cognitivo-Comportamental , Hipersensibilidade Alimentar , Pais , Qualidade de Vida , Humanos , Hipersensibilidade Alimentar/psicologia , Hipersensibilidade Alimentar/terapia , Criança , Pais/psicologia , Terapia Cognitivo-Comportamental/métodos , Adaptação Psicológica , Família/psicologia , Adolescente , Pré-EscolarRESUMO
The coronavirus disease 2019 (COVID-19) pandemic substantially impacted different age groups, with children and young people not exempted. Many have experienced enduring health consequences. Presently, there is no consensus on the health outcomes to assess in children and young people with post-COVID-19 condition. Furthermore, it is unclear which measurement instruments are appropriate for use in research and clinical management of children and young people with post-COVID-19. To address these unmet needs, we conducted a consensus study, aiming to develop a core outcome set (COS) and an associated core outcome measurement set (COMS) for evaluating post-COVID-19 condition in children and young people. Our methodology comprised of two phases. In phase 1 (to create a COS), we performed an extensive literature review and categorisation of outcomes, and prioritised those outcomes in a two-round online modified Delphi process followed by a consensus meeting. In phase 2 (to create the COMS), we performed another modified Delphi consensus process to evaluate measurement instruments for previously defined core outcomes from phase 1, followed by an online consensus workshop to finalise recommendations regarding the most appropriate instruments for each core outcome. In phase 1, 214 participants from 37 countries participated, with 154 (72%) contributing to both Delphi rounds. The subsequent online consensus meeting resulted in a final COS which encompassed seven critical outcomes: fatigue; post-exertion symptoms; work/occupational and study changes; as well as functional changes, symptoms, and conditions relating to cardiovascular, neuro-cognitive, gastrointestinal and physical outcomes. In phase 2, 11 international experts were involved in a modified Delphi process, selecting measurement instruments for a subsequent online consensus workshop where 30 voting participants discussed and independently scored the selected instruments. As a result of this consensus process, four instruments met a priori consensus criteria for inclusion: PedsQL multidimensional fatigue scale for "fatigue"; PedsQL gastrointestinal symptom scales for "gastrointestinal"; PedsQL cognitive functioning scale for "neurocognitive" and EQ-5D for "physical functioning". Despite proposing outcome measurement instruments for the remaining three core outcomes ("cardiovascular", "post-exertional malaise", "work/occupational and study changes"), a consensus was not achieved. Our international, consensus-based initiative presents a robust framework for evaluating post-COVID-19 condition in children and young people in research and clinical practice via a rigorously defined COS and associated COMS. It will aid in the uniform measurement and reporting of relevant health outcomes worldwide.
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COVID-19 , Síndrome de COVID-19 Pós-Aguda , Adolescente , Criança , Humanos , Técnica Delphi , Avaliação de Resultados em Cuidados de Saúde , Projetos de Pesquisa , Resultado do TratamentoRESUMO
BACKGROUND: There is a high prevalence and complex overlap between type 1 diabetes (T1D) and disordered eating. However, screening for disordered eating in children and young people (CYP) with T1D is not routinely conducted, with reluctance reported by both professionals and parents. This study aimed to validate a parent-reported version of a validated disordered eating screening tool for CYP with T1D (the Diabetes Eating Problems Survey-Revised; DEPS-R). METHODS: The existing DEPS-R was adapted for parental use. Eighty-nine parents of CYP with T1D aged 11-14 years completed the parent-reported DEPS-R and other questionnaires related to demographics, child eating behaviours and parental well-being. CYP of parents were invited to participate, with 51 CYP completing the validated CYP-reported DEPS-R for comparison. RESULTS: The parent-reported DEPS-R demonstrated good internal consistency (Cronbach's α = 0.89). Moderate to good inter-rater reliability was found between the parent-reported DEPS-R and CYP-reported DEPS-R (ICC 0.746, 95% CI = 0.554-0.855, p < 0.001), indicating good convergent validity. Construct validity with hypothesised variables, including specific eating behaviours, diabetes-related distress, well-being, CYP BMI, gender and parental worry about CYP disordered eating, suggested validity of the measure. However, some hypothesised variables did not significantly correlate with the parent-reported DEPS-R as expected. CONCLUSIONS: The parent-reported DEPS-R has demonstrated good reliability and validity, and it may provide clinical benefit by increasing screening and early detection of disordered eating in CYP with T1D. Whilst novel and providing stepped increase in our knowledge, these findings would benefit from further validation (e.g. in a larger sample and responsiveness).
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Diabetes Mellitus Tipo 1 , Transtornos da Alimentação e da Ingestão de Alimentos , Criança , Humanos , Adolescente , Diabetes Mellitus Tipo 1/complicações , Diabetes Mellitus Tipo 1/diagnóstico , Diabetes Mellitus Tipo 1/epidemiologia , Reprodutibilidade dos Testes , Inquéritos e Questionários , Transtornos da Alimentação e da Ingestão de Alimentos/diagnóstico , Transtornos da Alimentação e da Ingestão de Alimentos/epidemiologia , PaisRESUMO
AIMS: Children and young people (CYP) with type 1 diabetes (T1D) are at increased risk of disordered eating. This study aimed to determine the feasibility and acceptability of a novel, theoretically informed, two-session psychoeducational intervention for parents to prevent disordered eating in CYP with T1D. METHODS: Parents of CYP aged 11-14 years with T1D were randomly allocated to the intervention or wait-list control group. Self-reported measures including the Diabetes Eating Problem Survey-Revised (DEPS-R), Problem Areas in Diabetes Parent Revised (PAID-PR), Child Eating Behaviour Questionnaire subscales (CEBQ), Warwick Edinburgh Mental Wellbeing Scale (WEMWBS), clinical outcomes (e.g. HbA1c, BMI, medication and healthcare utilisation) and process variables, were collected at baseline, 1-and 3-month assessments. Acceptability data were collected from intervention participants via questionnaire. RESULTS: Eighty-nine parents were recruited, which exceeded recruitment targets, with high intervention engagement and acceptability (<80% across domains). A signal of efficacy was observed across outcome measures with moderate improvements in the CEBQ subscale satiety responsiveness (d = 0.55, 95% CI 0.01, 1.08) and child's BMI (d = -0.56, 95% CI -1.09, 0.00) at 3 months compared with controls. Trends in the anticipated direction were also observed with reductions in disordered eating (DEPS-R) and diabetes distress (PAID-PR) and improvements in wellbeing (WEMWBS). CONCLUSIONS: This is the first study to have co-designed and evaluated a novel parenting intervention to prevent disordered eating in CYP with T1D. The intervention proved feasible and acceptable with encouraging effects. Preparatory work is required prior to definitive trial to ensure the most relevant primary outcome measure and ensure strategies for optimum outcome completion.
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Diabetes Mellitus Tipo 1 , Transtornos da Alimentação e da Ingestão de Alimentos , Criança , Humanos , Adolescente , Diabetes Mellitus Tipo 1/complicações , Diabetes Mellitus Tipo 1/terapia , Estudos de Viabilidade , Pais , Inquéritos e Questionários , Transtornos da Alimentação e da Ingestão de Alimentos/prevenção & controleRESUMO
This European Academy of Allergy and Clinical Immunology guideline provides recommendations for diagnosing IgE-mediated food allergy and was developed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. Food allergy diagnosis starts with an allergy-focused clinical history followed by tests to determine IgE sensitization, such as serum allergen-specific IgE (sIgE) and skin prick test (SPT), and the basophil activation test (BAT), if available. Evidence for IgE sensitization should be sought for any suspected foods. The diagnosis of allergy to some foods, such as peanut and cashew nut, is well supported by SPT and serum sIgE, whereas there are less data and the performance of these tests is poorer for other foods, such as wheat and soya. The measurement of sIgE to allergen components such as Ara h 2 from peanut, Cor a 14 from hazelnut and Ana o 3 from cashew can be useful to further support the diagnosis, especially in pollen-sensitized individuals. BAT to peanut and sesame can be used additionally. The reference standard for food allergy diagnosis is the oral food challenge (OFC). OFC should be performed in equivocal cases. For practical reasons, open challenges are suitable in most cases. Reassessment of food allergic children with allergy tests and/or OFCs periodically over time will enable reintroduction of food into the diet in the case of spontaneous acquisition of oral tolerance.
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Hipersensibilidade Alimentar , Criança , Humanos , Hipersensibilidade Alimentar/diagnóstico , Testes Cutâneos , Imunoglobulina E , Alérgenos , PólenRESUMO
BACKGROUND: Recent years have seen record levels of migration to Europe. Female migrants are at heightened risk of developing mental health disorders, yet they face barriers to accessing mental health services in their host countries. This systematic review aims to summarise the barriers and facilitators to accessing mental health support for female migrants in Europe. METHODS: The review follows PRISMA guidelines, and the protocol was pre-published on PROSPERO. Six electronic databases were searched: CINAHL, Global Health Database, Medline, PsycARTICLES, PsycINFO and Web of Science. Thematic analysis was undertaken on the identified studies. A feminist quality appraisal tool was applied. RESULTS: Eight qualitative, six quantitative and five mixed methods studies were identified. Barriers included a lack of information, stigma, religious and cultural practices and beliefs, and a lack of consideration of gender-specific needs within the health system. Gender-sensitive services, supportive general practitioners and religious leaders facilitated access. CONCLUSIONS: The design of mental health research, services, policies, and commissioning of support for migrants must consider female migrant needs. Mental health support services must be culturally aware and gender sensitive. REGISTRATION: The review protocol was registered on the International Prospective Register of Systematic Reviews (PROSPERO, registration number CRD42021235571.
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Refugiados , Migrantes , Feminino , Humanos , Saúde Mental , Feminismo , Europa (Continente) , Refugiados/psicologia , Atenção Primária à Saúde , Acessibilidade aos Serviços de SaúdeRESUMO
BACKGROUND: Emerging evidence points to rising levels of psychological distress resulting from the COVID-19 pandemic. There is a need for self-administered, low-cost, and accessible interventions that facilitate wellbeing and growth. METHODS: This study used a randomised controlled trial (RCT) design to investigate the effects of a two-week positivity-oriented photography intervention on wellbeing and posttraumatic growth in comparison to a control group. Participants were adults between the ages of 21 and 80 living in the UK recruited between May and August 2020 (n = 109). RESULTS: After adjusting for baseline wellbeing, both wellbeing and PTG were significantly higher in the intervention group compared to the control group following intervention completion, with this effect remaining similar at one-month follow-up. CONCLUSIONS: The study offers preliminary evidence that a brief self-administered photography intervention could hold therapeutic value.
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COVID-19 , Crescimento Psicológico Pós-Traumático , Adulto , Humanos , Adulto Jovem , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou maisRESUMO
BACKGROUND: Older adult carers of people who experience psychosis are at increased risk of developing physical and mental health problems due to the compounding factors of supporting their care-recipient and the health changes associated with ageing. Effective interventions exist but can be difficult to access and maintain prolonged engagement. Self-directed writing therapies, frequently referred to as Written Emotional Disclosure (WED), might be a suitable alternative intervention to improve the wellbeing of carers. METHODS: This study aimed to determine the feasibility (recruitment, retention and primary outcome completion) and acceptability of a specific WED intervention known as Positive Written Disclosure (PWD). Informal carers of people with psychosis were randomised to PWD, neutral writing or no writing. Quantitative outcomes including positive and negative affect, carer wellbeing, quality of life, depression, anxiety, stress, self-efficacy, leisure time satisfaction as well as health care utilisation were collected at baseline, 1-, 3-, and 6-month assessments. Qualitative feedback was also collected via questionnaire and semi-structured interviews from those randomised to either writing group. RESULTS: We successfully met our progression criteria, recruiting to target and within timeframes whilst attaining 97% retention and 84% primary outcome data completed at 6 months. Carers randomised to the positive writing group described the intervention as enabling them to have a more positive attitude and focus on activities for themselves. Both writing groups described their tasks as providing distraction from caring responsibilities. However, some carers found the narrow positive emotion focus challenging. CONCLUSIONS: PWD is a feasible and acceptable intervention for older adult carers of people with psychosis within a community setting. Further refinement of the writing protocol to include choice in type of emotion disclosed in addition to screening for some level of need may be required in future trials to reduce floor/ceiling effects of outcomes which may explain the lack of change observed.
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Cuidadores , Transtornos Psicóticos , Humanos , Idoso , Cuidadores/psicologia , Revelação , Qualidade de Vida , Estudos de Viabilidade , Transtornos Psicóticos/psicologiaRESUMO
Eating disorders (EDs) have an estimated prevalence rate of 1%-5% across Europe. Effective adjunct interventions are needed to support the 20%-40% of families whose recovery requires additional support to first line approaches. This systematic review and meta-analysis aimed to establish whether multi-family therapy (MFT) improves the physical and psychological health of patients and family members. Searches were conducted in PsycINFO, MEDLINE, PubMed, EMBASE, CINAHL, and the Cochrane Library in March 2021. 15 studies (850 patients) met the inclusion criteria. Meta-analysis demonstrated MFT resulted in significant benefits in weight gain, ED symptoms, patients' and parents' depression symptoms, and parents' negative experiences of caregiving. However, significant improvements were only evident when comparisons were drawn before and after the intervention; these dissipated when MFT was compared to another intervention. There was no evidence MFT improves family functioning, positive aspects of caregiving, nor patient and parental anxiety. Intervention completion rates ranged from 86% to 100% indicating a high level of acceptability. Studies varied with regard to intervention length and structure, follow-up period, and outcome measures utilised; most were rated as moderate or weak in methodological quality. More rigorous and large scale randomised controlled trials are needed to fully assess the effectiveness of MFT.
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Terapia Familiar , Transtornos da Alimentação e da Ingestão de Alimentos , Terapia Familiar/métodos , Transtornos da Alimentação e da Ingestão de Alimentos/terapia , Humanos , Longevidade , Saúde Mental , PaisRESUMO
We conducted a systematic review to answer the following: (a) Is there any evidence to support increased prevalence of suicidality and self-harm (i.e. self-harm or suicidality) in urban versus rural environments? (b) What aspects of the urban environment pose risk for suicidality and self-harm? Thirty-five studies met our criteria. Our findings reflect a mixed picture, but with a tendency for urban living to be associated with an increased risk of suicidality and self-harm over rural living, particularly for those living in deprived areas. Further research should focus on the clustering and additive effects of risk and protective factors for suicidality and self-harm in urban environments.
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Comportamento Autodestrutivo , Suicídio , Humanos , Irlanda/epidemiologia , Comportamento Autodestrutivo/epidemiologia , Ideação Suicida , Reino Unido/epidemiologiaRESUMO
The COVID-19 pandemic raised acute awareness regarding inequities and inequalities and poor clinical outcomes amongst ethnic minority groups. Studies carried out in North America, the UK and Australia have shown a relatively high burden of asthma and allergies amongst ethnic minority groups. The precise reasons underpinning the high disease burden are not well understood, but it is likely that this involves complex gene-environment interaction, behavioural and cultural elements. Poor clinical outcomes have been related to multiple factors including access to health care, engagement with healthcare professionals and concordance with advice which are affected by deprivation, literacy, cultural norms and health beliefs. It is unclear at present if allergic conditions are intrinsically more severe amongst patients from ethnic minority groups. Most evidence shaping our understanding of disease pathogenesis and clinical management is biased towards data generated from white population resident in high-income countries. In conjunction with standards of care, it is prudent that a multi-pronged approach towards provision of composite, culturally tailored, supportive interventions targeting demographic variables at the individual level is needed, but this requires further research and validation. In this narrative review, we provide an overview of epidemiology, sensitization patterns, poor clinical outcomes and possible factors underpinning these observations and highlight priority areas for research.
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Asma , COVID-19 , COVID-19/epidemiologia , Países Desenvolvidos , Minorias Étnicas e Raciais , Etnicidade , Humanos , Grupos Minoritários , PandemiasRESUMO
BACKGROUND: Parents of children with food allergies (CwFA) experience reduced quality of life (QoL) and may have reduced access to in-person interventions in the COVID-19 pandemic. This trial developed and evaluated an online, self-help, information provision website, aimed at improving QoL in parents of CwFA. METHODS: In a single-blinded, randomised controlled trial (RCT), participants were randomised to either receive access to the website or a waiting-list control. At baseline, post-intervention (week 4) and follow-up (week 8), measures of parental food allergy-related QoL, depression, anxiety, stress, intolerance of uncertainty (IU) and self-efficacy were obtained. RESULTS: A total of 205 participants were randomised; 97% were females, 91% white and 78% educated ≥ degree level, with a mean age of 38.95 years (SD = 6.89). 44.9% (n = 92) were retained at follow-up. The arms did not significantly differ on any outcome at any time point. For a sub-group of participants above the clinical cut-off for depression at baseline, the intervention may have improved QoL. Participants reported the website content as useful and accessible, but accessed it infrequently. In baseline data, IU and self-efficacy were significantly associated with QoL. CONCLUSION: While the COVID-19 pandemic has encouraged greater provision of online interventions, our RCT suggests this particular website is not suitable for this population in general, although future research could examine its efficacy for depressed parents of CwFA, to increase confidence that the sub-group finding was not a Type 1 error. The baseline data suggest IU and self-efficacy remain potential proximal targets for intervention.
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COVID-19 , Hipersensibilidade Alimentar , Intervenção Baseada em Internet , Adulto , COVID-19/epidemiologia , Criança , Feminino , Hipersensibilidade Alimentar/terapia , Humanos , Pais , Qualidade de Vida , SARS-CoV-2RESUMO
Children and young people (CYP) with type 1 diabetes (T1D) are twice as likely to develop disordered eating (T1DE) and clinical eating disorders than those without. This has significant implications for physical and mental health, with some eating disorders associated with repeated diabetic ketoacidosis and higher HbA1c levels, both of which are life threatening. There is currently limited psychological support for CYP and families with T1D but increasingly, policy and practice are suggesting disordered eating in T1D may be effectively prevented through psychological intervention. We describe the development and theoretical underpinnings of a preventative psychological intervention for parents of CYP aged 11-14, with T1D. The intervention was informed by psychological theory, notably the Information Motivation Behaviour Skills model and Behaviour Change Technique Taxonomy. The intervention was co-developed with an expert advisory group of clinicians, and families with T1D. The manualised intervention includes two online group workshops, and supplementary online materials. The intervention continues to evolve, and feasibility findings will inform how best to align the intervention with routine care in NHS diabetes teams. Early detection and intervention are crucial in preventing T1DE, and it is hoped that the current intervention can contribute to improving the psychological and physical wellbeing of young people and families managing T1D.
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AIMS: Increasing evidence suggests that children and young people with type 1 diabetes (T1D) are at greater risk of disordered eating compared to children without T1D. Disordered eating in T1D has been linked to impaired wellbeing, increased health service use and early mortality. To address this problem, we will co-develop a psycho-education intervention for parents of children and young people with T1D, informed by the Information Motivation Behavioural Skills model. METHODS: The objective of this study is to assess the feasibility and acceptability of the intervention compared to a waitlist control group using a feasibility randomised controlled trial (RCT) design. We aim to recruit 70 parents of children and young people with T1D (11-14 years), 35 in each arm. Those assigned to the intervention will be invited to participate in two workshops of 2 h each. Parents will be asked to complete outcome measures regarding eating habits, diabetes management, as well as a questionnaire based on the Information Motivation Behavioural Skills model which provides a theoretical foundation for the intervention. These will be completed at baseline, 1- and 3-month post-intervention. Children and young people will be asked to complete questionnaires on their eating behaviours at the same time intervals. Parents randomised to receive the intervention will be invited to take part in interviews to feedback on the intervention and research protocol acceptability. CONCLUSION: It is anticipated that the psycho-education intervention aimed at parents will help prevent the development of disordered eating in children and young people with T1D and improve parental wellbeing. The results of this feasibility trial will determine whether this intervention approach is acceptable to families living with T1D, and whether a definitive RCT of intervention effectiveness is justified. Qualitative findings will be used to refine the intervention and study protocols. TRIAL REGISTRATION: This protocol has been registered with ClinicalTrials.gov [Identifier: NCT04741568].
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Diabetes Mellitus Tipo 1 , Transtornos da Alimentação e da Ingestão de Alimentos , Adolescente , Criança , Diabetes Mellitus Tipo 1/complicações , Diabetes Mellitus Tipo 1/terapia , Estudos de Viabilidade , Transtornos da Alimentação e da Ingestão de Alimentos/prevenção & controle , Humanos , Pais , Ensaios Clínicos Controlados Aleatórios como Assunto , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Due to an increased risk of sexually transmitted infections (STIs), gay, bisexual and other men who have sex with men (MSM) have been recommended to receive vaccinations against human papillomavirus, meningitis C and hepatitis A/B. This review aimed to compare the rates of vaccine acceptability, uptake and completion, and to identify determinants of vaccine outcomes specific to MSM to inform a theoretical framework. METHODS: In January 2020 four databases were explored to identify vaccination behaviours and associated factors among MSM. A narrative systematic review and meta-analysis were performed. Data were synthesised for theoretical modelling. RESULTS: Seventy-eight studies, mostly from the USA, were included. The average vaccine acceptability was 63% (median = 72%, range: 30%-97%), vaccine uptake 45% (median = 42%, range: 5%-100%) and vaccine completion 47% (median = 45%, range: 12%-89%). Six categories of factors associated with vaccination acceptability, uptake and completion were conceptualised: Individual (e.g., demographic and psychosocial); Interpersonal (e.g., peer education); Healthcare provider (e.g., vaccine recommendation); Organisational and practice setting (e.g., routine collection of patient sexual orientation information that is integrated into a clinical decision support system); Community environment (e.g., targeted health promotion campaigns); and National, state and local policy environment (e.g., public health guidelines targeting MSM). CONCLUSION: Despite overall high levels of acceptability, uptake and completion rates were below targets predicted by cost-effectiveness modelling across all recommended vaccines. These parameters may need to be adjusted for more precise estimations of cost-effectiveness. Addressing the multiple levels of determinants, as outlined in our theoretical framework, will help guide interventions to increase vaccine completion among MSM.