Clinical effectiveness of the psychological therapy Mental Health Intervention for Children with Epilepsy in addition to usual care compared with assessment-enhanced usual care alone: a multicentre, randomised controlled clinical trial in the UK.

BACKGROUND: Mental health difficulties are common in children and young people with chronic health conditions, but many of those in need do not access evidence-based psychological treatments. The study aim was to evaluate the clinical effectiveness of integrated mental health treatment for children and young people with epilepsy, a common chronic health condition known to be associated with a particularly high rate of co-occurring mental health difficulties. METHODS: We conducted a parallel group, multicentre, open-label, randomised controlled trial of participants aged 3-18 years, attending epilepsy clinics across England and Northern Ireland who met diagnostic criteria for a common mental health disorder. Participants were randomised (1:1; using an independent web-based system) to receive the Mental Health Intervention for Children with Epilepsy (MICE) in addition to usual care, or assessment-enhanced usual care alone (control). Children and young people in both groups received a full diagnostic mental health assessment. MICE was a modular psychological intervention designed to treat common mental health conditions in children and young people using evidence-based approaches such as cognitive behaviour therapy and behavioural parenting strategies. Usual care for mental health disorders varied by site but typically included referral to appropriate services. Participants, along with their caregivers, and clinicians were not masked to treatment allocation but statisticians were masked until the point of analysis. The primary outcome, analysed by modified intention-to-treat, was the parent-report Strengths and Difficulties Questionnaire (SDQ) at 6 months post-randomisation. The study is complete and registered with ISRCTN (57823197). FINDINGS: 1401 young people were potentially deemed eligible for study inclusion. Following the exclusion of 531 young people, 870 participants were assessed for eligibility and completed the SDQ, and 480 caregivers provided consent for study inclusion between May 20, 2019, and Jan 31, 2022. Between Aug 28, 2019, and Feb 21, 2022, 334 participants (mean ages 10·5 years [SD 3·6] in the MICE group vs 10·3 [4·0] in control group at baseline) were randomly assigned to an intervention using minimisation balanced by age, primary mental health disorder, diagnosis of intellectual disability, and autistic spectrum disorder at baseline. 168 (50%) of the participants were female and 166 (50%) were male. 166 participants were randomly assigned to the MICE group and 168 were randomly assigned to the control group. At 6 months, the mean SDQ difficulties for the 148 participants in the MICE group was 17·6 (SD 6·3) and 19·6 (6·1) for the 148 participants in the control group. The adjusted effect of MICE was -1·7 (95% CI -2·8 to -0·5; p=0·0040; Cohen's d, 0·3). 14 (8%) patients in the MICE group experienced at least one serious adverse event compared with 24 (14%) in the control group. 68% percent of serious adverse events (50 events) were admission due to seizures. INTERPRETATION: MICE was superior to assessment-enhanced usual care in improving symptoms of emotional and behavioural difficulties in young people with epilepsy and common mental health disorders. The trial therefore shows that mental health comorbidities can be effectively and safely treated by a variety of clinicians, utilising an integrated intervention across ages and in the context of intellectual disability and autism. The evidence from this trial suggests that such a model should be fully embedded in epilepsy services and serves as a model for other chronic health conditions in young people. FUNDING: UK National Institute for Health Research Programme Grants for Applied Research programme and Epilepsy Research UK Endeavour Project Grant.

Mental health in the COVID-19 pandemic: A longitudinal analysis of the CLoCk cohort study.

BACKGROUND: Little is known about the long-term mental health consequences of the pandemic in children and young people (CYP), despite extremely high levels of exposure to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus and the disruption to schooling and leisure activities due to the resultant restrictions. There are mixed findings from systematic reviews of how the pandemic affected CYP's mental health, which may be due to heterogeneous methods and poor quality studies. Most, but not all, suggest deterioration in mental health but population level studies may obscure the differing experiences of subgroups. The study questions are: (i) are there subgroups of CYP with distinct mental health profiles over the course of the second year of the Coronavirus Disease 2019 (COVID-19) pandemic (between April 2021 and May 2022); and (ii) do vulnerability factors influence CYP's mental health trajectories. METHODS AND FINDINGS: A matched longitudinal cohort study of non-hospitalised test-positive and test-negative 11- to 17-year-old CYP in England were recruited from the UK Health Security Agency having undergone PCR testing for COVID-19. They completed the Strengths and Difficulties Questionnaire (SDQ) at least twice over a 12-month follow-up period. Overall, 8,518 of 17,918 (47.5%) CYP who returned their first SDQ at 3 or 6 months post-testing were included in the analytical sample. Associations between age, sex, ethnicity, socioeconomic status (SES), and an educational health and care plan (EHCP, indicating special educational needs) on SDQ score trajectories were examined separately, after adjusting for PCR test result. Findings from multilevel mixed-effects linear regression model showed that on average mental health symptoms as measured by the total SDQ score increased over time (B = 0.11 (per month), 95% CI = 0.09 to 0.12, p < 0.001) although this increase was small and not clinically significant. However, associations with time varied by age, such that older participants reported greater deterioration in mental health over time (B = 0.12 (per month), 95% CI = 0.10 to 0.14 for 15 to 17y; 0.08 (95% CI = 0.06 to 0.10) for 11 to 14y; pinteraction = 0.002) and by sex, with greater deterioration in girls. Children with an EHCP experienced less deterioration in their mental health compared to those without an EHCP. There was no evidence of differences in rate of change in total SDQ by ethnicity, SES, or physical health. Those with worse prior mental health did not appear to be disproportionately negatively affected over time. There are several limitations of the methodology including relatively low response rates in CLoCk and potential for recall bias. CONCLUSIONS: Overall, there was a statistically but not clinically significant decline in mental health during the pandemic. Sex, age, and EHCP status were important vulnerability factors that were associated with the rate of mental health decline, whereas ethnicity, SES, and prior poor physical health were not. The research highlights individual factors that could identify groups of CYP vulnerable to worsening mental health.

Prevalence and co-occurrence of cognitive impairment in children and young people up to 12-months post infection with SARS-CoV-2 (Omicron variant).

BACKGROUND: Cognitive impairment is often reported after SARS-CoV-2 infection, yet evidence gaps remain. We aimed to (i) report the prevalence and characteristics of children and young people (CYP) reporting "brain fog" (i.e., cognitive impairment) 12-months post PCR-proven SARS-CoV-2 infection and determine whether differences by infection status exist and (ii) explore the prevalence of CYP experiencing cognitive impairment over a 12-month period post-infection and investigate the relationship between cognitive impairment and poor mental health and well-being, mental fatigue and sleep problems. METHODS: The Omicron CLoCk sub-study, set up in January 2022, collected data on first-time PCR-test-positive and PCR-proven reinfected CYP at time of testing and at 3-, 6- and 12-months post-testing. We describe the prevalence of cognitive impairment at 12-months, indicating when it was first reported. We characterise CYP experiencing cognitive impairment and use chi-squared tests to determine whether cognitive impairment prevalence varied by infection status. We explore the relationship between cognitive impairment and poor mental health and well-being, mental fatigue and trouble sleeping using validated scales. We examine associations at 3-, 6- and 12-months post-testing by infection status using Mann-Whitney U and chi-square tests. RESULTS: At 12-months post-testing, 7.0 % (24/345) of first-positives and 7.5 % (27/360) of reinfected CYP experienced cognitive impairment with no difference between infection-status groups (p = 0.78). The majority of these CYP experienced cognitive impairment for the first time at either time of testing or 3-months post-test (no difference between the infection-status groups; p = 0.60). 70.8 % of first-positives experiencing cognitive impairment at 12-months, were 15-to-17-years-old as were 33.3 % of reinfected CYP experiencing cognitive impairment (p < 0.01). Consistently at all time points post-testing, CYP experiencing cognitive impairment were more likely to score higher on all Strengths and Difficulties Questionnaire subscales, higher on the Chalder Fatigue sub-scale for mental fatigue, lower on the Short Warwick-Edinburgh Mental Wellbeing Scale and report more trouble sleeping. CONCLUSIONS: CYP have a fluctuating experience of cognitive impairment by 12-months post SARS-CoV-2-infection. Cognitive impairment is consistently correlated with poorer sleep, behavioural and emotional functioning over a 12-month period. Clinicians should be aware of cognitive impairment post-infection and its co-occurring nature with poorer sleep, behavioural and mental health symptoms.

Developing survey weights to ensure representativeness in a national, matched cohort study: results from the children and young people with Long Covid (CLoCk) study.

BACKGROUND: Findings from studies assessing Long Covid in children and young people (CYP) need to be assessed in light of their methodological limitations. For example, if non-response and/or attrition over time systematically differ by sub-groups of CYP, findings could be biased and any generalisation limited. The present study aimed to (i) construct survey weights for the Children and young people with Long Covid (CLoCk) study, and (ii) apply them to published CLoCk findings showing the prevalence of shortness of breath and tiredness increased over time from baseline to 12-months post-baseline in both SARS-CoV-2 Positive and Negative CYP. METHODS: Logistic regression models were fitted to compute the probability of (i) Responding given envisioned to take part, (ii) Responding timely given responded, and (iii) (Re)infection given timely response. Response, timely response and (re)infection weights were generated as the reciprocal of the corresponding probability, with an overall 'envisioned population' survey weight derived as the product of these weights. Survey weights were trimmed, and an interactive tool developed to re-calibrate target population survey weights to the general population using data from the 2021 UK Census. RESULTS: Flexible survey weights for the CLoCk study were successfully developed. In the illustrative example, re-weighted results (when accounting for selection in response, attrition, and (re)infection) were consistent with published findings. CONCLUSIONS: Flexible survey weights to address potential bias and selection issues were created for and used in the CLoCk study. Previously reported prospective findings from CLoCk are generalisable to the wider population of CYP in England. This study highlights the importance of considering selection into a sample and attrition over time when considering generalisability of findings.

Training and supervision of physical health professionals to implement mental health care in paediatric epilepsy clinics.

BACKGROUND: Children and young people with epilepsy are more likely to experience multiple mental health problems than those without chronic physical health conditions, yet they often do not receive evidence-based (or indeed any) psychological interventions. Integrated healthcare is recommended as a solution to address these inequalities, but remains limited in the United Kingdom. This is partly due to the lack of training and availability of ongoing supervision for clinicians to ensure the safe and effective delivery of treatments. This study aimed to train and provide supervision for health professionals to deliver a modular cognitive-behavioural intervention for common mental health problems, optimised for use in paediatric epilepsy. Specifically, this study aimed to measure therapist competence and evaluate the acceptability of training and supervision. METHODS: Fifteen health professionals working in paediatric epilepsy services were trained over a six-month period. Training included face-to-face training workshops and completing at least one training case of a young person with epilepsy and anxiety, depression and/or behavioural problems under close clinical supervision. Throughout the training, health professionals were offered weekly one-hour supervisions with an experienced Clinical Psychologist. Clinical competence was assessed using a widely used measure of therapist competence in cognitive-behavioural therapy. Rates of attendance at supervision sessions and therapist ratings of satisfaction were recorded. RESULTS: At the end of the six-month training, 14 health professionals reached clinical competence in delivering the mental health intervention. One person left the service and therefore did not complete the training. Overall, health professionals were satisfied with the training and supervision. However, 14 % of supervision sessions were cancelled and a further 11 % were not attended. Supervision sessions were also often shorter than the standard hour used in mental health settings (M = 41.18 min, SD = 10.30). CONCLUSIONS: Our findings suggest that health professionals working in paediatric epilepsy services can be trained to deliver a psychological intervention with proficiency. However, the supervision model typically used in mental health may need adaptation to be sustainable in physical health settings. Future research is needed to evaluate the impact of training and supervision on patient outcomes and to ensure that ethical delivery of psychological interventions by health professionals without a mental health background.

Using a novel methodology to map Post-COVID services for children and young people in England: a web-based systematic search.

BACKGROUND: Post-COVID Condition (PCC), also known as 'Long COVID,' refers to persistent symptoms following a coronavirus 2 (SARS-CoV-2) infection. The prevalence of PCC in children and adolescents varies, impacting multiple body systems and affecting daily functioning. Specialised paediatric hubs were established in England to address the needs of young individuals with PCC. Additional local services also emerged, yet patients report challenges accessing services. To better understand the landscape of paediatric PCC services, we used a novel methodology using a web-based systematic search. METHODS: A web-based search was conducted in July 2023 using DEVONagent Pro. Search terms related to Long COVID and Pediatrics in England. Eligible sources providing information on PCC services for children and young people were included. A supplementary manual search and NHS England Post-COVID Network were also consulted. Data extraction included service location, characteristics, and referral pathways. Population estimates were derived from UK Census data. RESULTS: Among 342 identified records, 27 services met eligibility criteria, distributed unevenly across regions. Specialised hubs covered 13 locations, while additional services were concentrated in the South of England and London. Services varied in team composition, age range treated, and support offered. A lack of standardised approaches for paediatric PCC was evident. DISCUSSION: We used a novel methodology for systematically mapping online resources, providing valuable insights into service accessibility and aiding the identification of potential gaps. We observed geographical disparities in access to paediatric PCC services and the absence of standardised approaches in managing symptoms. Given the challenges faced by young individuals seeking support for their PCC the need for equitable and standardised care became apparent. The study contributes to closing the research-practice gap and calls for further research to identify effective treatments for paediatric PCC, acknowledging the diversity of reported symptoms and the importance of tailored approaches.

Long COVID in Children and Young after Infection or Reinfection with the Omicron Variant: A Prospective Observational Study.

To describe the prevalence of long COVID in children infected for the first time (n = 332) or reinfected (n = 243) with Omicron compared with test-negative children (n = 311). Overall, 12%-16% of those infected with Omicron met the research definition of long COVID at 3 and 6 months after infection, with no evidence of difference between cases of first positive and reinfected (Pχ2 = 0.17).

Predictive model for long COVID in children 3 months after a SARS-CoV-2 PCR test.

BACKGROUND: To update and internally validate a model to predict children and young people (CYP) most likely to experience long COVID (i.e. at least one impairing symptom) 3 months after SARS-CoV-2 PCR testing and to determine whether the impact of predictors differed by SARS-CoV-2 status. METHODS: Data from a nationally matched cohort of SARS-CoV-2 test-positive and test-negative CYP aged 11-17 years was used. The main outcome measure, long COVID, was defined as one or more impairing symptoms 3 months after PCR testing. Potential pre-specified predictors included SARS-CoV-2 status, sex, age, ethnicity, deprivation, quality of life/functioning (five EQ-5D-Y items), physical and mental health and loneliness (prior to testing) and number of symptoms at testing. The model was developed using logistic regression; performance was assessed using calibration and discrimination measures; internal validation was performed via bootstrapping and the final model was adjusted for overfitting. RESULTS: A total of 7139 (3246 test-positives, 3893 test-negatives) completing a questionnaire 3 months post-test were included. 25.2% (817/3246) of SARS-CoV-2 PCR-positives and 18.5% (719/3893) of SARS-CoV-2 PCR-negatives had one or more impairing symptoms 3 months post-test. The final model contained SARS-CoV-2 status, number of symptoms at testing, sex, age, ethnicity, physical and mental health, loneliness and four EQ-5D-Y items before testing. Internal validation showed minimal overfitting with excellent calibration and discrimination measures (optimism-adjusted calibration slope: 0.96575; C-statistic: 0.83130). CONCLUSIONS: We updated a risk prediction equation to identify those most at risk of long COVID 3 months after a SARS-CoV-2 PCR test which could serve as a useful triage and management tool for CYP during the ongoing pandemic. External validation is required before large-scale implementation.

"A greatest hits compilation of mental health support": A qualitative study of health professionals' perceptions of modular CBT in pediatric epilepsy services.

OBJECTIVES: The primary aim of this qualitative study was to explore the views of health professionals, with little previous clinical mental health training, of an adapted modular cognitive-behavioral intervention (MATCH-ADTC) for common mental health problems in children and young people with epilepsy. METHODS: Healthcare Professionals (HCPs) and their supervisors were interviewed at the start (n = 23) and end (n = 15) of the six-month training period. The interviews were transcribed verbatim and analyzed using thematic analysis. RESULTS: Three higher order themes with sub-themes were identified: (1) strengths of the MATCH-ADTC content and manual; (2) expectations of the treatment; and (3) improving practice with MATCH-ADTC. Overall impressions of the training and treatment were largely positive, with HCPs viewing MATCH-ADTC as an acceptable treatment for the families that they worked with. HCPs highlighted some challenges in delivering an integrated service, particularly relating to the time commitment involved and their own confidence in delivering the intervention, as many participants did not have a mental health background. CONCLUSIONS: The findings suggested that the intervention and training was acceptable to HCPs working in pediatric epilepsy services, and confidence grew over the six-month training period. Further research is needed to understand how to best train, supervise, and support HCPs in pediatric epilepsy services to deliver mental health treatments.

Feasibility of telephone-delivered therapy for common mental health difficulties embedded in pediatric epilepsy clinics.

BACKGROUND: Mental and physical health treatment should be delivered together for children and young people with epilepsy. Training healthcare professionals (HCPs) in epilepsy services to deliver mental health interventions is an important way to facilitate integrated care. OBJECTIVE: To determine the feasibility of remotely delivered assessment and psychological treatment for mental health difficulties delivered by HCPs in pediatric epilepsy clinics with limited formal training in psychological interventions. We hypothesized that it would be (i) feasible to train HCPs to deliver the psychological intervention and (ii) that participants receiving the psychological therapy would report reductions in symptoms of mental health difficulties including anxiety, depression, and behavior difficulties and improve quality of life. METHODS: Thirty-four children and young people with epilepsy who had impairing symptoms of a common mental health difficulty (anxiety, depression, disruptive behavior, and/or trauma) were allocated to receive 6 months of a modular cognitive behavioral intervention delivered by a HCP with limited formal psychological therapy experience. Thirteen HCPs were trained in delivery of the intervention. Healthcare professional competence was assessed in a two-stage process. Parent-reported measures of mental health symptoms and quality of life were completed at baseline and following the intervention. Paired t-tests were used to analyze changes in symptoms over time. RESULTS: All thirteen HCPs who participated in the training were considered competent in therapeutic delivery by the end of the training period. Twenty-three patients completed pre- and post-intervention measures and were included in the analysis. There were statistically significant improvements in: symptoms of mental health problems (p = 0.01; Cohen's d = 0.62), total impact of mental health problems (p = 0.03; Cohen's d = 0.52), anxiety and depression symptoms (p = 0.02; Cohen's d = 0.57) and quality of life (p = 0.01; Cohen's d = 0.57). CONCLUSION: A modular cognitive behavioral treatment delivered over the telephone by HCPs with limited experience of psychological therapy was feasible and effective in treating mental health problems in children and young people with epilepsy. Health-related Quality of Life also improved over the duration of treatment. A randomized controlled trial (RCT) is needed to demonstrate efficacy of the intervention.

Post-Covid-19 condition (Long Covid) in children and young people 12 months after infection or reinfection with the Omicron variant: a prospective observational study.

Our previous study in children and young people (CYP) at 3- and 6-months post-infection showed that 12-16% of those infected with the Omicron (B.1.1.529) variant of SARS-CoV-2 met the research definition of Long Covid, with no differences between first-positive and reinfected CYP. The primary objective of the current study is to explore the impact of the Omicron variant of SARS-CoV-2 infection on young people 12 months post infection. 345 CYP aged 11-17 years with a first laboratory-confirmed infection with the Omicron variant and 360 CYP reinfected with the Omicron variant completed an online questionnaire assessing demographics, symptoms, and their impact shortly after testing and again at 3-, 6-and 12-months post-testing. Vaccination status was determined from information held at UKHSA. Comparisons between groups were made using chi-squared, Mann-Whitney U, and Kruskal-Wallis tests. The most common symptoms in first-positive and reinfected CYP 12-months post-testing were tiredness (35.7 and 33.6% respectively) and sleeping difficulties (27.5 and 28.3% respectively). Symptom profiles, severity and impact were similar in the two infection status groups. Overall, by 12-months, 17.4% of first-positives and 21.9% of reinfected CYP fulfilled the research consensus Long Covid definition (p = 0.13). 12-months post Omicron infection, there is little difference between first-positive and reinfected CYP with respect to symptom profiles and impact. Clinicians may not therefore need to consider number of infections and type of variant when developing treatment plans. Further studies are needed to assess causality of reported symptoms up to 12-months after SARS-CoV-2 infection.

Examining change in the mental health of young people with epilepsy following a successful psychological intervention.

OBJECTIVE: Evaluate the cognitive, behavioural and affective processes involved in therapeutic change for young people with epilepsy and mental health difficulties receiving an integrated mental health intervention. METHODS: As part of a mixed methods convergent design, qualitative data were gathered in parallel to quantitative data at two timepoints in a randomised controlled trial testing the Mental Health Intervention for Children with Epilepsy in addition to usual care. Twenty-five young people and/or their families were interviewed before and after the intervention about the young person's mental and physical health, and their experience of therapy. Interview data were analysed inductively, idiographically and longitudinally using Interpretative Phenomenological Analysis combined with Framework Analysis. RESULTS: The young people's emotional and behaviour problems improved, mirroring the trial's quantitative outcomes. Their anxiety decreased and behaviour improved as they acquired tools and understanding through therapy. Problems, like aggressive behaviours and emotional outbursts, were also reduced, with young people gaining increased awareness and ability to self-regulate and parents learning to contain their child's impulsive behaviours. CONCLUSIONS: The qualitative findings complement the MICE trial's significant positive quantitative results by providing insight and context to the therapeutic change, providing vivid insight into the mechanisms of therapy for individual families.

This study involves young people with epilepsy and mental health difficulties who received an integrated mental health intervention called the Mental Health Intervention for Children with Epilepsy (MICE). The effectiveness of the MICE intervention (in addition to usual care) was assessed by comparing it to only usual care. This article reports on the changes in the behaviour, thinking, feeling of the young people after they received therapy. The research data was qualitative, using transcripts from interviews with 25 young people and/or their families. There was also some quantitative data, in the form of questionnaires. Both types of data were gathered at two different time points and compared over time. Then the results from the two types of data were considered together in a so-called mixed methods approach. During the qualitative interviews, participants were asked about the young person's mental and physical health, as well as their therapy experiences. The interview data were analysed using an in-depth approach to the analysis. This article describes improvements in emotional and behavioural problems among the young participants, which align with the positive mental health outcomes observed in the trial's quantitative data. Participant quotes before and after the intervention reveal reduced anxiety and improved behaviour as the therapy gave the young people new tools and understanding. Parents of young people with intellectual disabilities also felt more confident in managing their children's fears. Aggressive behaviours and emotional outbursts decreased, and young people developed greater self-awareness and self-control. The qualitative findings provide context and insight into the therapeutic change observed in the MICE trial. Understanding the mechanisms of therapy is crucial. In summary, this study sheds light on how therapy positively impacts young people's mental health and behaviour, with benefits for both the young people and their families.

"People don't have the answers": A qualitative exploration of the experiences of young people with Long COVID.

Young people living with Long COVID are learning to navigate life with a constellation of poorly understood symptoms. Most qualitative studies on experiences living with Long COVID focus on adult populations. This study aimed to understand the experiences of young people living with Long COVID. Qualitative, semi-structured interviews were conducted (n = 16); 11 young people (aged 13-19) and five parents were recruited from the Children and Young People with Long COVID (CLoCk) study (n = 11) or its patient and public involvement and engagement (PPIE) group (n = 5). Thematic analysis generated four themes: (i) Unravelling Long COVID: Exploring Symptom Journeys and Diagnostic Dilemmas; (ii) Identity Disruption and Adjustment; (iii) Long COVID's Ripple Effect: the impact on Mental Health, Connections, and Education; and (iv) Navigating Long COVID: barriers to support and accessing services. Treatment options were perceived as not widely available or ineffective, emphasising the need for viable and accessible interventions for young people living with Long COVID.

Why was the study done? Capturing the broad impact of Long COVID and the experiences of young people and their families living with persisting symptoms will help to identify the unique needs and challenges experienced by this population and help shape effective treatments going forward. What did the researchers do? Researchers conducted interviews with children and young people living with Long COVID. Parents of young people were also invited to participate to gain a comprehensive understanding of the effects of Long COVID and its impact on the wider family. What did the researchers find? Analysis of 11 interviews with young people and 5 with parents revealed four themes central to young people's experiences of living with Long COVID relating to unknowns and uncertainties, identity shifts, the impact of symptoms and accessing support. What do findings mean? Findings from the study suggest the implications of Long COVID were far-reaching and impairing. Current treatment options were not perceived as widely available or effective, suggesting a need for further research to develop effective interventions for young people living with Long COVID.

Reporting involvement activities with children and young people in paediatric research: a framework analysis.

BACKGROUND: The active involvement of patients and the public in the design and delivery of health research has been increasingly encouraged, if not enforced. Knowledge of how this is realised in practice, especially where children and young people (CYP) are concerned, is limited, partly due to the low level of reporting of patient and public involvement (PPI) in general. The aim of this work was to assess how researchers funded by the National Institute for Health and Care Research (NIHR) report the involvement of CYP in the design and conduct of child health research to better understand the opportunities offered to CYP, and the realities of involvement in practice. METHODS: A participation matrix, analysis framework and accompanying tools were adapted from existing frameworks, including a child-rights informed framework, the Guidance for Reporting Involvement of Patients and the Public Checklist Short Form (GRIPP2SF), and NIHR reporting expectations. Child-focused research reports were identified from the NIHR Journals Library, including any interventional or observational study involving CYP aged 0-< 24 years. In two co-design workshops with healthcare professionals and CYP, we tested and refined the participation matrix, analysis framework and accompanying tools. RESULTS: Only thirty-two NIHR reports out of 169 (19%) were identified as relevant and included reporting of PPI with CYP. We identified significant variability in the way PPI with CYP was reported. Only 4/32 (12%) reports fully met NIHR (and GRIPP2SF) reporting criteria. Only 3/32 (9%) reports formally evaluated or self-reflected on PPI activities with CYP, whilst 15/32 (47%) provided minimal information about CYP involvement. The most common approach to involving CYP (23/32, 72%) was through the medium of existing groups or networks. CONCLUSION: Despite the NIHR's commitment to increase the quality, transparency, and consistency of reporting PPI, the reporting of involvement with CYP remains sub-optimal. Neglecting to report key details of involvement methods and impacts deprives the research community of knowledge to advance the field of delivering 'meaningful' PPI with CYP. Practical guidance on how researchers can report the processes and outputs of CYP involvement more rigorously may help child health researchers to involve them more meaningfully. This research offers practical tools informed by CYP to aid the reporting process.

BACKGROUND: Children and young people can (and should) be involved in the design of child-health research. How this works in practice is limited due to the low-level reporting of involvement activities. AIM: We wanted to understand how researchers funded by the National Institute for Health and Care Research (NIHR) are reporting involvement activities with children and young people in child-health research. WHAT WE DID AND HOW WE DID IT: A team of healthcare researchers (working in child-health research), a parent, and children and young people adapted existing tools to assess how the involvement of children and young people is reported in child-health research. We looked at reports in an online library to see how researchers are meeting the reporting guidelines set by the NIHR. FINDINGS: Despite the reporting guidelines provided by the NIHR, only four out of thirty-two reports followed this. It is still unclear who is involved, why, and what outcomes and impact involvement has on the research process, on children and young people and/or on researchers. This is a missed opportunity to learn from previous experiences and to build on good practice. Further work is needed to understand why and how the NIHR, and other funders of health research collect such information, and what their plans are for sharing the findings with the wider research community.

Loneliness Trajectories, Associated Factors and Subsequent Health in Children and Young People During the COVID-19 Pandemic: A National Matched Cohort Study.

Purpose: Loneliness is common amongst children and young people (CYP) and is an independent risk factor for poor health. This study aimed to i) determine whether subgroups of CYP with different loneliness trajectories (during the second year of the pandemic) exist; ii) examine associations with socio-demographic characteristics and subsequent health; and iii) understand whether associations between loneliness and subsequent health were modified by SARS-CoV-2 infection. Methods: A total of 5851 CYP (N=3260 SARS-CoV-2 positive and 2591 SARS-CoV-2 negative) provided data on loneliness (via the validated 3-item version of the UCLA Loneliness Scale for Children) at least twice in a 12-month period post PCR index-testing (conducted October 2020-March 2021). Latent class growth analyses were used to identify distinct classes of loneliness trajectories. Multinomial logistic regression was used to identify socio-demographic characteristics associated with class membership. Logistic regression models assessed the odds of reporting impairing symptoms 12-months post index-test. Results: Four distinct loneliness trajectories were identified: three mostly stable (low, medium, high) and one low-increasing trajectory. Being older, female, living in more deprived areas and testing negative were associated with greater odds of being in the highest vs lowest loneliness trajectory; eg OR for female vs male: 5.6 (95% CI:4.1,7.8); OR for 15-17 vs 11-14 years: 4.5 (95% CI:3.4,6.0). Following higher loneliness trajectories was associated with higher odds of experiencing impairing symptoms 12-months post index-test: ORadjusted (compared to lowest loneliness trajectory) were 15.9 (95% CI:11.9,21.3) (high loneliness), 6.5 (5.3,7.9) (medium loneliness) and 2.3 (1.9,2.8) (low-increasing loneliness). There was no evidence that this association was modified by PCR index-test result. Conclusion: About 5.3% of CYP were classified into a group experiencing (chronically) high loneliness. Being female, older and from more deprived areas were risk factors of belonging to this group. Results suggest that even small increases from low loneliness levels may be associated with worse health outcomes.

Factor associated with the occurrence of epilepsy in autism: a systematic review.

This systematic review aimed to identify factors significantly associated with the occurrence of epilepsy in autistic individuals and to consider the impact of study quality on findings. Electronic databases were systematically searched on October 2nd, 2020 and records retrieved were limited to those published from 2000 onwards. Study quality was categorised as 'good', 'moderate' or 'weak'. Fifty-three studies were included and in studies where the prevalence of epilepsy was reported (n = 257,892), 18,254 (7%) had co-occurring epilepsy. Intellectual disability/cognitive impairment was the most commonly reported risk factor associated with occurrence of epilepsy in autistic individuals. The evidence supporting other, potentially relevant factors was weak and inconsistent and requires further evaluation. Only 9/53 studies were considered 'good' quality.

Children and Young People with Long COVID-Comparing Those Seen in Post-COVID Services with a Non-Hospitalised National Cohort: A Descriptive Study.

BACKGROUND: Post-COVID services have been set up in England to treat children with ongoing symptoms of Long COVID. To date, the characteristics of children seeking treatment from these services has not been described. PURPOSE: (1) to describe the characteristics of children aged 11-17 referred to the Pan-London Post-COVID service and (2) to compare characteristics of these children with those taking part in the United Kingdom's largest research study of Long COVID in children (CLoCk). DESIGN: Data from 95 children seeking treatment from the Post-COVID service between May 2021 and August 2022 were included in the study. Their demographic characteristics, symptom burden and the impact of infection are described and compared to children from CLoCk. RESULTS: A high proportion of children from the Post-COVID service and CLoCk reported experiencing health problems prior to the pandemic. Almost all Post-COVID service children met the research Delphi definition of Long COVID (94.6%), having multiple symptoms that impacted their lives. Symptoms were notably more severe than the participants in CLoCk. CONCLUSIONS: This study describes the characteristics of children seeking treatment for Long COVID compared to those identified in the largest longitudinal observational study to date. Post-COVID service children have more symptoms and are more severely affected by their symptoms following infection with COVID-19 than children in the CLoCk study. Research to understand predisposing factors for severity and prognostic indicators is essential to prevent this debilitating condition. Evaluation of short- and long-term outcomes of interventions by clinical services can help direct future therapy for this group.

The CLoCk study: A retrospective exploration of loneliness in children and young people during the COVID-19 pandemic, in England.

BACKGROUND: During the COVID-19 pandemic children and young people (CYP) were socially restricted during a stage of life crucial to development, potentially putting an already vulnerable population at higher risk of loneliness, social isolation, and poorer wellbeing. The objectives of this study are to conduct an exploratory analysis into loneliness before and during the pandemic, and determine which self-reported factors are associated with loneliness. METHODS AND FINDINGS: Participants from The Children with Long COVID (CLoCk) national study were invited to take part via an online survey, with a total of 31,017 participants taking part, 31,016 of which reported on their experience of loneliness. Participants retrospectively answered questions on demographics, lifestyle, physical health and mental health and loneliness before the pandemic and at the time of answering the survey. Before the pandemic 6.5% (2,006/31,016) of participants reported experiencing loneliness "Often/Always" and at the time of survey completion 17.4% (5,395/31,016) reported feeling lonelier. There was an association between meeting the research definition of long COVID and loneliness [3.49 OR, 95%CI 3.28-3.72]. CYP who reported feeling lonelier at the time of the survey than before the pandemic were assigned female at birth, older CYP, those from Black/African/Caribbean/Black British or other ethnicity groups, those that had 3-4 siblings and lived in more deprived areas. CONCLUSIONS: We demonstrate associations between multiple factors and experiences of loneliness during the pandemic. There is a need for a multi-faceted integrated approach when developing interventions targeted at loneliness. It is important to follow up the CYP involved at regular intervals to investigate the progression of their experience of loneliness over time.

A Cross-Sectional Study of the Health of Emerging Young Adults in England Following a COVID-19 Infection.

PURPOSE: This study describes long COVID symptomatology in a national sample of 18- to 20-year-olds with Polymerase Chain Reaction (PCR)-confirmed Severe acute respiratory syndrome coronavirus 2 (SARS­CoV­2) and matched test-negative controls in England. Symptoms in 18- to 20-year-olds were compared to symptoms in younger adolescents (aged 11-17 years) and all adults (18+). METHODS: A national database was used to identify SARS-CoV-2 PCR-positive 18- to 20-year-olds and test-negative controls matched by time of test, age, gender, and geographical region. Participants were invited to complete a questionnaire about their health retrospectively at time of test and also when completing the questionnaire. Comparison cohorts included children and young people with long COVID and REal-time Assessment of Community Transmission studies. RESULTS: Of 14,986 people invited, 1,001 were included in the analysis (562 test-positive; 440 test-negative). At testing, 46.5% of test-positives and 16.4% of test-negatives reported at least one symptom. At the time of questionnaire completion (median 7 months post-testing), 61.5% of test-positives and 47.5% of test-negatives reported one or more symptoms. The most common symptoms were similar amongst test-positives and test-negatives and included tiredness (44.0%; 35.7%), shortness of breath (28.8%; 16.3%), and headaches (13.7%; 12.0%). Prevalence rates were similar to those reported by 11-17-year-olds (66.5%) and higher than those reported in all adults (37.7%). For 18- to 20-year-olds, there was no significant difference in health-related quality of life and well-being (p > .05). However, test-positives reported being significantly more tired than test-negatives (p = .04). DISCUSSION: Seven months after PCR test, a high proportion of test-positive and test-negative 18- to 20-year-olds reported similar symptoms to each other and to those experienced by younger and older counterparts.

Post-COVID-19 condition at 6 months and COVID-19 vaccination in non-hospitalised children and young people.

OBJECTIVES: To describe the physical and mental health of children and young people (CYP) 6 months after infection with SARS-CoV-2 and explore whether this varies by COVID-19 vaccination. DESIGN: A non-hospitalised, national cohort of people aged 11-17 years old with PCR-confirmed SARS-CoV-2 infection and PCR negatives matched at study invitation, by age, sex, region and date of testing who completed questionnaires 6 months after PCR testing. The questionnaire included 21 symptoms and standardised scales (eg, EQ-5D-Y and Chalder Fatigue Scale). RESULTS: 6407 test-positive and 6542 test-negative CYP completed the 6-month questionnaire: 60.9% of test-positive vs 43.2% of test-negative CYP reported at least one symptom 6 months post-test; 27.6% of test-positive vs 15.9% of test-negative CYP reported 3+ symptoms. Common symptoms at 6 months were tiredness and shortness of breath among both test-positive and test-negative CYP; however, the prevalence of both was higher in test-positive (38.4% and 22.8%, respectively) compared with test-negative CYP (26.7% and 10.9%, respectively). 24.5% test-positive vs 17.8% test-negative CYP met the Delphi research definition of long COVID. Mental health, well-being, fatigue and health-related quality of life scores were similar among test-positive and test-negative CYP 6 months post-test. Similarly, symptomatology was similar among COVID-19-vaccinated and COVID-19-unvaccinated test-positive and test-negative CYP. CONCLUSIONS: Six-months post-PCR testing, CYP who tested positive for SARS-CoV-2 had similar symptoms to those who tested negative, but test-positive CYP had higher symptom prevalence. Mental health, well-being, fatigue and health-related quality of life were similar among test-positive and test-negative CYP, and symptoms at 6 months were similar in COVID-19 vaccinated and unvaccinated. TRIAL REGISTRATION NUMBER: ISRCTN 34804192.