Identifying barriers to outpatient appointment attendance in patient groups at risk of inequity: a mixed methods study in a London NHS trust.

BACKGROUND: There is significant health inequity in the United Kingdom (U.K.), with different populations facing challenges accessing health services, which can impact health outcomes. At one London National Health Service (NHS) Trust, data showed that patients from deprived areas and minority ethnic groups had a higher likelihood of missing their first outpatient appointment. This study's objectives were to understand barriers to specific patient populations attending first outpatient appointments, explore systemic factors and assess appointment awareness. METHODS: Five high-volume specialties identified as having inequitable access based on ethnicity and deprivation were selected as the study setting. Mixed methods were employed to understand barriers to outpatient attendance, including qualitative semi-structured interviews with patients and staff, observations of staff workflows and interrogation of quantitative data on appointment communication. To identify barriers, semi-structured interviews were conducted with patients who missed their appointment and were from a minority ethnic group or deprived area. Staff interviews and observations were carried out to further understand attendance barriers. Patient interview data were analysed using inductive thematic analysis to create a thematic framework and triangulated with staff data. Subthemes were mapped onto a behavioural science framework highlighting behaviours that could be targeted. Quantitative data from patient interviews were analysed to assess appointment awareness and communication. RESULTS: Twenty-six patients and 11 staff were interviewed, with four staff observed. Seven themes were identified as barriers - communication factors, communication methods, healthcare system, system errors, transport, appointment, and personal factors. Knowledge about appointments was an important identified behaviour, supported by eight out of 26 patients answering that they were unaware of their missed appointment. Environmental context and resources were other strongly represented behavioural factors, highlighting systemic barriers that prevent attendance. CONCLUSION: This study showed the barriers preventing patients from minority ethnic groups or living in deprived areas from attending their outpatient appointment. These barriers included communication factors, communication methods, healthcare the system, system errors, transport, appointment, and personal factors. Healthcare services should acknowledge this and work with public members from these communities to co-design solutions supporting attendance. Our work provides a basis for future intervention design, informed by behavioural science and community involvement.

Shorter night-time sleep duration and later sleep timing from infancy to adolescence.

BACKGROUND: Here, we (a) examined the trajectories of night-time sleep duration, bedtime and midpoint of night-time sleep (MPS) from infancy to adolescence, and (b) explored perinatal risk factors for persistent poor sleep health. METHODS: This study used data from 12,962 participants in the Avon Longitudinal Study of Parents and Children (ALSPAC). Parent or self-reported night-time sleep duration, bedtime and wake-up time were collected from questionnaires at 6, 18 and 30 months, and at 3.5, 4-5, 5-6, 6-7, 9, 11 and 15-16 years. Child's sex, birth weight, gestational age, health and temperament, together with mother's family adversity index (FAI), age at birth, prenatal socioeconomic status and postnatal anxiety and depression, were included as risk factors for persistent poor sleep health. Latent class growth analyses were applied first to detect trajectories of night-time sleep duration, bedtime and MPS, and we then applied logistic regressions for the longitudinal associations between risk factors and persistent poor sleep health domains. RESULTS: We obtained four trajectories for each of the three sleep domains. In particular, we identified a trajectory characterized by persistent shorter sleep, a trajectory of persistent later bedtime and a trajectory of persistent later MPS. Two risk factors were associated with the three poor sleep health domains: higher FAI with increased risk of persistent shorter sleep (OR = 1.20, 95% CI = 1.11-1.30, p < .001), persistent later bedtime (OR = 1.28, 95% CI = 1.19-1.39, p < .001) and persistent later MPS (OR = 1.30, 95% CI = 1.22-1.38, p < .001); and higher maternal socioeconomic status with reduced risk of persistent shorter sleep (OR = 0.99, 95% CI = 0.98-1.00, p = .048), persistent later bedtime (OR = 0.98, 95% CI = 0.97-0.99, p < .001) and persistent later MPS (OR = 0.99, 95% CI = 0.98-0.99, p < .001). CONCLUSIONS: We detected trajectories of persistent poor sleep health (i.e. shorter sleep duration, later bedtime and later MPS) from infancy to adolescence, and specific perinatal risk factors linked to persistent poor sleep health domains.

The interaction between polygenic risk and environmental influences: A direct test of the 3P model of insomnia in adolescents.

BACKGROUND: Stress is a universal phenomenon and one of the most common precipitants of insomnia. However, not everyone develops insomnia after experiencing a stressful life event. This study aims to test aspects of Spielman's '3P model of insomnia' (during adolescence) by exploring the extent to which: (a) insomnia symptoms are predicted by polygenic scores (PGS); (b) life events predict insomnia symptoms; (c) the interaction between PGS and life events contribute to the prediction of insomnia symptoms; (d) gene-environment interaction effects remain after controlling for sex. METHODS: The sample comprised 4,629 twins aged 16 from the Twin Early Development Study who reported on their insomnia symptoms and life events. PGS for insomnia were calculated. In order to test the main hypothesis of this study (a significant interaction between PGS and negative life events), we fitted a series of mixed effect regressions. RESULTS: The best fit was provided by the model including sex, PGS for insomnia, negative life events, and their interactions (AIC = 26,158.7). Our results show that the association between insomnia symptoms and negative life events is stronger for those with a higher genetic risk for insomnia. CONCLUSIONS: This work sheds light on the complex relationship between genetic and environmental factors implicated for insomnia. This study has tested for the first time the interaction between genetic predisposition (PGS) for insomnia and environmental stressors (negative life events) in adolescents. This work represents a direct test of components of Spielman's 3P model for insomnia which is supported by our results.

Randomised controlled trial of the effects of kefir on behaviour, sleep and the microbiome in children with ADHD: a study protocol.

INTRODUCTION: Current interventions for children with attention-deficit/hyperactivity disorder (ADHD) are primarily medication, behavioural therapy and parent training. However, research suggests dietary manipulations may provide therapeutic benefit for some. There is accumulating evidence that the gut microbiome may be atypical in ADHD, and therefore, manipulating gut bacteria in such individuals may help alleviate some of the symptoms of this condition. The aim of this study is to explore the effects of supplementation with kefir (a fermented dairy drink) on ADHD symptomatology, sleep, attention and the gut microbiome in children diagnosed with ADHD. METHODS AND ANALYSIS: A 6-week randomised, double-blind, placebo-controlled trial in 70 children aged 8-13 years diagnosed with ADHD. Participants will be recruited throughout the UK, through support groups, community groups, schools, social media and word of mouth. Children will be randomised to consume daily either dairy kefir or a placebo dairy drink for 6 weeks. The primary outcome, ADHD symptomatology, will be measured by The Strengths and Weakness of ADHD-symptoms and Normal-behaviour scale. Secondary outcomes will include gut microbiota composition (using shotgun metagenomic microbiome sequencing), gut symptomatology (The Gastrointestinal Severity Index questionnaire), sleep (using 7-day actigraphy recordings, The Child's Sleep Habits Questionnaire and Sleep Self Report questionnaire), inattention and impulsivity (with a computerised Go/NoGo test). Assessments will be conducted prior to the intervention and at the end of the intervention. Interaction between time (preintervention/postintervention) and group (probiotic/placebo) is to be analysed using a Mixed Model Analysis of Variances. ETHICS AND DISSEMINATION: Ethical approval for the study was granted by St Mary's University Ethics Committee. Results will be disseminated through peer-reviewed publications, presentations to the scientific community and support groups. TRIAL REGISTRATION NUMBER: NCT05155696.

Lessons Learned From COVID-19 Lockdown: An ASPED/MENA Study on Lifestyle Changes and Quality of Life During Ramadan Fasting in Children and Adolescents Living With Type 1 Diabetes.

Background: Lockdown was a unique experience that affected many aspects of life, particularly during the challenge of Ramadan fasting (RF). Studying this can increase understanding of the effects of lifestyle changes on quality of life (QoL) for children with type 1 diabetes (T1D) during RF. Methods: A cross-sectional study that assessed the effect of lockdown on lifestyle and QoL on fasting children living with T1D during Ramadan in the Middle East and North Africa region (2020-2021). We compared the child (self) and parent (proxy) reports using PEDQoL v3.0 disease specific questionnaire during lockdown and non-lockdown periods, and assessed correlations with lifestyle changes using regression and gap analyses. Results: A total of 998 reports from 499 children with T1D aged 8 to 18 years (study = 276, control = 223), and their parents during RF in lockdown and non-lockdown periods. Fathers were more involved in their children's care during lockdown (P = .019). Patients had better compliance with treatment (P = .002), a reversed sleep pattern (P = .033), increased food intake (P ⩽ .001), and less exercise (P < .001). Children and parents perceived better QoL during lockdown (P ⩽.001) with no differences between their reports in "Diabetes Symptoms", "Treatment Adherence," and "Communication" domains. Self and proxy reports were different in all domains during non-lockdown (P = <.001-.009). In gap analysis, although not statistically significant, the gap was approximated between children's and parents' perceptions in all domains during lockdown. Conclusion: COVID-19 lockdown had a positive impact on QoL of children living with T1D during RF, possibly due to lifestyle changes and superior psychosocial family dynamics.

Sub-types of insomnia in adolescents: Insights from a quantitative/molecular twin study.

Background: Insomnia with short sleep duration has been postulated as more severe than that accompanied by normal/long sleep length. While the short duration subtype is considered to have greater genetic influence than the other subtype, no studies have addressed this question. This study aimed to compare these subtypes in terms of: (1) the heritability of insomnia symptoms; (2) polygenic scores (PGS) for insomnia symptoms and sleep duration; (3) the associations between insomnia symptoms and a wide variety of traits/disorders. Methods: The sample comprised 4000 pairs of twins aged 16 from the Twins Early Development Study. Twin models were fitted to estimate the heritability of insomnia in both groups. PGS were calculated for self-reported insomnia and sleep duration and compared among participants with short and normal/long sleep duration. Results: Heritability was not significantly different in the short sleep duration group (A = 0.13 [95%CI = 0.01, 0.32]) and the normal/long sleep duration group (A = 0.35 [95%CI = 0.29, 0.40]). Shared environmental factors accounted for a substantial proportion of the variance in the short sleep duration group (C = 0.19 [95%CI = 0.05, 0.32]) but not in the normal/long sleep duration group (C = 0.00 [95%CI = 0.00, 0.04]). PGS did not differ significantly between groups although results were in the direction expected by the theory. Our results also showed that insomnia with short (as compared to normal/long) sleep duration had a stronger association with anxiety and depression (p < .05)-although not once adjusting for multiple testing. Conclusions: We found mixed results in relation to the expected differences between the insomnia subtypes in adolescents. Future research needs to further establish cut-offs for 'short' sleep at different developmental stages and employ objective measures of sleep.

Problematic technology use and sleep quality in young adulthood: novel insights from a nationally representative twin study.

STUDY OBJECTIVES: Digital technology use is associated with poor sleep quality in adolescence and young adulthood although research findings have been mixed. No studies have addressed the association between the two using a genetically informative twin design which could extend our understanding of the etiology of this relationship. This study aimed to test: (1) the association between adolescents' perceived problematic use of digital technology and poor sleep quality, (2) whether the association between problematic use of technology and poor sleep quality remains after controlling for familial factors, and (3) genetic and environmental influences on the association between problematic use of technology and poor sleep quality. METHODS: Participants were 2232 study members (18-year-old twins) of the Environmental Risk (E-Risk) Longitudinal Twin Study. The sample was 48.9% male, 90% white, and 55.6% monozygotic. We conducted regression and twin difference analyses and fitted twin models. RESULTS: Twin differences for problematic use of technology were associated with differences for poor sleep quality in the whole sample (p < 0.001; B = 0.15) and also when we limited the analyses to identical twins only (p < 0.001; B = 0.21). We observed a substantial genetic correlation between problematic use of technology and sleep quality (rA = 0.31), whereas the environmental correlation was lower (rE = 0.16). CONCLUSIONS: Adolescent reported problematic use of digital technology is associated with poor sleep quality-even after controlling for familial factors including genetic confounds. Our results suggest that the association between adolescents' sleep and problematic digital technology use is not accounted for by shared genetic liability or familial factors but could reflect a causal association. This robust association needs to be examined in future research designed to test causal associations.

Sleep and Mental Health Problems in Children and Adolescents.

Previous reviews have described the links between sleep and mental health extensively. In this narrative review, we focus on literature published during the last decade investigating the links between sleep and mental health difficulties in childhood and adolescence. More specifically, we focus on the mental health disorders listed in the most recent edition of the Diagnostic and Statistical Manual of Mental Disorders. We also discuss possible mechanisms underlying these associations. The review ends with a discussion of possible future lines of enquiry.

Associations between sleep variables and ostensibly paranormal experiences and paranormal beliefs: A scoping review.

Night-time is a period of great significance for many people who report paranormal experiences. However, there is limited understanding of the associations between sleep variables and seemingly paranormal experiences and/or beliefs. The aim of this review is to improve our understanding of these associations while unifying a currently fragmented literature-base into a structured, practical review. In this pre-registered scoping review, we searched for relevant studies in MEDLINE (PubMed), PsycINFO (EBSCO), Web of Science and EMBASE using terms related to sleep and ostensibly paranormal experiences and beliefs. Forty-four studies met all inclusion criteria. All were cross-sectional and most investigated sleep paralysis and/or lucid dreaming in relation to ostensibly paranormal experiences and paranormal beliefs. Overall, there were positive associations between many sleep variables (including sleep paralysis, lucid dreams, nightmares, and hypnagogic hallucinations) and ostensibly paranormal experiences and paranormal beliefs (including those of ghosts, spirits, and near-death experiences). The findings of this review have potential clinical implications such as reducing misdiagnosis and treatment development and provide foundations for further research. Our findings also highlight the importance of understanding why so many people report 'things that go bump in the night'.

Behaviour genetics and sleep: A narrative review of the last decade of quantitative and molecular genetic research in humans.

During the last decade quantitative and molecular genetic research on sleep has increased considerably. New behavioural genetics techniques have marked a new era for sleep research. This paper provides a summary of the most important findings from the last ten years, on the genetic and environmental influences on sleep and sleep disorders and their associations with health-related variables (including anxiety and depression) in humans. In this review we present a brief summary of the main methods in behaviour genetic research (such as twin and genome-wide association studies). We then discuss key research findings on: genetic and environmental influences on normal sleep and sleep disorders, as well as on the association between sleep and health variables (highlighting a substantial role for genes in individual differences in sleep and their associations with other variables). We end by discussing future lines of enquiry and drawing conclusions, including those focused on problems and misconceptions associated with research of this type. In this last decade our knowledge about genetic and environmental influences on sleep and its disorders has expanded. Both, twin and genome-wide association studies show that sleep and sleep disorders are substantially influenced by genetic factors and for the very first time multiple specific genetic variants have been associated with sleep traits and disorders.

Isolated sleep paralysis: Clinical features, perception of aetiology, prevention and disruption strategies in a large international sample.

STUDY OBJECTIVES: Isolated sleep paralysis is a benign but frightening condition characterised by a temporary inability to move at sleep onset or upon awakening. Despite the prevalence of this condition, little is known concerning its clinical features, associated demographic characteristics, and prevention as well as disruption strategies. METHODS: An online cross-sectional study was conducted. The sample comprised 3523 participants who had reported at least one lifetime episode of ISP and 3288 participants without a lifetime episode. Participants answered a survey including questions about sleep quality, sleep paralysis, and sleep paralysis prevention/disruption techniques. RESULTS: A total of 6811 participants were investigated (mean age = 46.9, SD = 15.4, age range = 18-89, 66.1% female). Those who reported experiencing ISP at least once during their lives reported longer sleep onset latencies, shorter sleep duration, and greater insomnia symptoms. Females (vs. male) and younger (vs. older) participants were more likely to experience ISP. Significant fear during episodes was reported by 76.0% of the participants. Most people (63.3%) who experienced ISP believed it to be caused by 'something in the brain'. A minority endorsed supernatural causes (7.1%). Five prevention strategies (e.g., changing sleep position, adjusting sleep patterns) with at least 60.0% effectiveness, and five disruption strategies (e.g., physical/bodily action, making noise) with varying degrees of effectiveness (ranging from 29.5 to 61.8) were identified through open-ended responses. CONCLUSIONS: ISP is associated with shorter sleep duration, longer sleep onset latency, and greater insomnia symptoms. The multiple prevention and disruption techniques identified in this study support existing treatment approaches and may inform subsequent treatment development. Implications for current diagnostic criteria are discussed.

The role of inflammation in the prospective associations between early childhood sleep problems and ADHD at 10 years: findings from a UK birth cohort study.

BACKGROUND: Several underlying mechanisms potentially account for the link between sleep and attention deficit and hyperactivity disorder (ADHD), including inflammation. However, studies so far have been cross sectional. We investigate (a) the association between early childhood sleep and probable ADHD diagnosis in childhood and (b) whether childhood circulating inflammatory markers mediate these prospective associations. METHODS: Data from the Avon Longitudinal Study of Parents and Children were available for 7,658 10-year-old children. Parent-reported sleep duration, night awakening frequency and regular sleep routines were collected at 3.5 years. The Development and Wellbeing Assessment was administered to capture children with clinically relevant ADHD symptoms, or probable ADHD diagnosis. Blood samples were collected at 9 years, from which two inflammatory markers were obtained [interleukin-6 (IL-6) and C-reactive protein (CRP)]. Logistic regression analyses were applied to investigate the associations between sleep variables at 3.5 years and probable ADHD diagnosis at 10 years. Further, path analysis was applied to examine the potential mediating role of inflammation at 9 years (as measured by CRP and IL-6) in the associations between early sleep and ADHD at 10 years. RESULTS: Less regular sleep routines (OR = 0.51, 95% CI = 0.28-0.93, p = .029), shorter nighttime sleep (OR = 0.70, 95% CI = 0.56-0.89, p = .004) and higher night awakening frequency (OR = 1.27, 95% CI = 1.06-1.52, p = .009) at 3.5 years were associated with higher odds of ADHD at 10 years. Further, IL-6 at 9 years, but not CRP, mediated the association between irregular sleep routines and ADHD (bias-corrected estimate, -0.002; p = .005) and between night awakening and ADHD (bias-corrected estimate, 0.002; p = .003). CONCLUSIONS: Several sleep problems in early childhood constitute a risk factor for probable ADHD diagnosis at 10 years. Further, these associations are partially mediated by IL-6 at 9 years. These results open a new research vista to the pathophysiology of ADHD and highlight sleep and inflammation as potential preventative targets for ADHD.

Editorial: Therapies for mental health difficulties: finding the sweet spot between standardization and personalization.

There are strong arguments for standardizing therapies for mental health difficulties in young people and for the development of digital therapies. At the same time, the importance of personalized treatments is also increasingly apparent. In this editorial, we discuss challenges and the continued need to find the sweet spot between standardization and personalization when it comes to therapies for mental health difficulties. We illustrate our discussion with reference to insomnia in adolescents/young adults as well as the chronic health condition type 1 diabetes.

The associations between paranormal beliefs and sleep variables.

Previous studies have found significant associations between paranormal beliefs and sleep variables. However, these have been conducted on a small scale and are limited in the number of sleep variables investigated. This study aims to fill a gap in the literature by investigating paranormal beliefs in relation to a wide range of sleep variables in a large sample. Participants (N = 8853) completed a survey initiated by the BBC Focus Magazine. They reported on their demographics, sleep disturbances and paranormal beliefs. Poorer subjective sleep quality (lower sleep efficiency, longer sleep latency, shorter sleep duration and increased insomnia symptoms) was associated with greater endorsement of belief in: (1) the soul living on after death; (2) the existence of ghosts; (3) demons; (4) an ability for some people to communicate with the dead; (5) near-death experiences are evidence for life after death; and (6) aliens have visited earth. In addition, episodes of exploding head syndrome and isolated sleep paralysis were associated with the belief that aliens have visited earth. Isolated sleep paralysis was also associated with the belief that near-death experiences are evidence for life after death. Findings obtained here indicate that there are associations between beliefs in the paranormal and various sleep variables. This information could potentially better equip us to support sleep via psychoeducation. Mechanisms underlying these associations are likely complex, and need to be further explored to fully understand why people sometimes report "things that go bump in the night".

Sleep disturbances in ADHD: investigating the contribution of polygenic liability for ADHD and sleep-related phenotypes.

Sleep disturbances are common in attention deficit hyperactivity disorder (ADHD) and associated with poor outcomes. We tested whether, in children with ADHD, (1) polygenic liability for sleep phenotypes is over- or under-transmitted from parents, (2) this liability is linked to comorbid sleep disturbances, and (3) ADHD genetic risk is associated with comorbid sleep disturbances. We derived polygenic scores (PGS) for insomnia, chronotype, sleep duration, and ADHD, in 758 children (5-18 years old) diagnosed with ADHD and their parents. We conducted polygenic transmission disequilibrium tests for each sleep PGS in complete parent-offspring ADHD trios (N = 328) and an independent replication sample of ADHD trios (N = 844). Next, we tested whether insomnia, sleep duration, and ADHD PGS were associated with co-occurring sleep phenotypes (hypersomnia, insomnia, restless sleep, poor sleep quality, and nightmares) in children with ADHD. Children's insomnia and chronotype PGS did not differ from mid-parent average PGS but long sleep duration PGS were significantly over-transmitted to children with ADHD. This was supported by a combined analysis using the replication sample. Insomnia, sleep duration, and ADHD PGS were not associated with comorbid sleep disturbances. There is weak evidence that children with ADHD over-inherit polygenic liability for longer sleep duration and do not differentially inherit polygenic liability for insomnia or chronotype. There was insufficient evidence that childhood sleep disturbances were driven by polygenic liability for ADHD or sleep traits, suggesting that sleep disturbances in ADHD may be aetiologically different to general population sleep phenotypes and do not index greater ADHD genetic risk burden.

Sex differences in sleep quality and psychological distress: Insights from a middle-aged twin sample from Spain.

There is a moderate association between poor sleep and psychological distress. There are marked sex differences in the prevalence of both variables, with females outnumbering males. However, the origin of these sex differences remains unclear. The objectives of this study were to: (1) study genetic and environmental influences on the relationship between poor sleep quality and psychological distress; and (2) test possible sex differences in this relationship. The sample comprised 3544 participants from the Murcia Twin Registry. Univariate and multivariate twin models were fitted to estimate the magnitude of genetic and environmental influences on both individual variance and covariance between poor sleep quality and psychological distress. Sleep quality and psychological distress were measured using the Pittsburgh Sleep Quality Index and the EuroQol five-dimensions questionnaire, respectively. The results reveal a strong genetic association between poor sleep quality and psychological distress, which accounts for 44% (95%CI: 27%-61%) of the association between these two variables. Substantial genetic (rA = 0.50; 95%CI: 0.32, 0.67) and non-shared environmental (rE = 0.41; 95%CI: 0.30, 0.52) correlations were also found, indicating a moderate overlap between genetic (and non-shared environmental) factors influencing both phenotypes. Equating sexes in sex-limitation models did not result in significant decreases in model fit. Despite the remarkable sex differences in the prevalence of both poor sleep quality and psychological distress, there were no sex differences in the genetic and environmental influences on these variables. This suggests that genetic factors play a similar role for men and women in explaining individual differences in both phenotypes and their relationship.

Perspectives on interpersonal touch are related to subjective sleep quality.

Affective touch has been reported for its calming effects; however, it is less clear whether touch is associated with sleep. Here, the relationship between different touch variables and self-reported sleep indicators was investigated. Data were extracted from the Touch Test, a cross-sectional survey conducted in 2020. Data from a sample of 15,049 healthy adults from the UK (mean age = 56.13, SD = 13.8; 75.4% female) were analysed. Participants were asked to attribute positive, negative, or no effects on sleep to hugs, strokes, massages, intimate touch, and sleep onset with and without touch. The time since last intentional touch, touch amount satisfaction, and childhood bed routine with hugs and kisses were assessed. Sleep quality, duration, latency, wake after sleep onset and diurnal preference were measured. Data were analysed using chi-square tests and logistic regressions. Affective touch before sleep was perceived to have positive effects on sleep. Touch recency emerged as a significant predictor for some sleep variables, with a longer timespan since the last intentional touch relating to improved sleep quality, longer sleep duration, and shorter and fewer instances of waking up after sleep onset in some participants. Experiencing too much touch was related to lower sleep quality and higher instances of waking up after sleep onset. These findings highlight the importance of interpersonal touch for subjective sleep quality.

Trialling a microbiome-targeted dietary intervention in children with ADHD-the rationale and a non-randomised feasibility study.

BACKGROUND: Dietary interventions have been previously explored in children with ADHD. Elimination diets and supplementation can produce beneficial behaviour changes, but little is known about the mechanisms mediating change. We propose that these interventions may work, in part, by causing changes in the gut microbiota. A microbiome-targeted dietary intervention was developed, and its feasibility assessed. METHODS: A non-randomised feasibility study was conducted on nine non-medicated children with ADHD, aged 8-13 years (mean 10.39 years), using a prospective one-group pre-test/post-test design. Participants were recruited from ADHD support groups in London and took part in the 6-week microbiome-targeted dietary intervention, which was specifically designed to impact the composition of gut bacteria. Children were assessed pre- and post-intervention on measures of ADHD symptomatology, cognition, sleep, gut function and stool-sample microbiome analysis. The primary aim was to assess the study completion rate, with secondary aims assessing adherence, adverse events (aiming for no severe and minimal), acceptability and suitability of outcome measures. RESULTS: Recruitment proved to be challenging and despite targeting 230 participants directly through support groups, and many more through social media, nine families (of the planned 10) signed up for the trial. The completion rate for the study was excellent at 100%. Exploration of secondary aims revealed that (1) adherence to each aspect of the dietary protocol was very good; (2) two mild adverse events were reported; (3) parents rated the treatment as having good acceptability; (4) data collection and outcome measures were broadly feasible for use in an RCT with a few suggestions recommended; (5) descriptive data for outcome measures is presented and suggests that further exploration of gut microbiota, ADHD symptoms and sleep would be helpful in future research. CONCLUSIONS: This study provides preliminary evidence for the feasibility of a microbiome-targeted dietary intervention in children with ADHD. Recruitment was challenging, but the diet itself was well-tolerated and adherence was very good. Families wishing to trial this diet may find it an acceptable intervention. However, recruitment, even for this small pilot study, was challenging. Because of the difficulty experienced recruiting participants, future randomised controlled trials may wish to adopt a simpler dietary approach which requires less parental time and engagement, in order to recruit the number of participants required to make meaningful statistical interpretations of efficacy. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03737877 . Registered 13 November 2018-retrospectively registered, within 2 days of the first participant being recruited.