Methodology of the SORENTO clinical trial: a prospective, randomised, active-controlled phase 3 trial assessing the efficacy and safety of high exposure octreotide subcutaneous depot (CAM2029) in patients with GEP-NET.

BACKGROUND: The current standard of care (SoC) for the initial treatment of unresectable or metastatic well-differentiated gastroenteropancreatic neuroendocrine tumours (GEP-NET) requires initiation of first-generation somatostatin receptor ligand (SRL) therapy, octreotide and lanreotide, which provide safe and efficacious tumour/symptom control in most patients. However, disease progression can occur with SoC SRL treatment and the optimal dose response of SRL remains unknown. Octreotide subcutaneous depot (CAM2029) is a novel, long-acting, high-exposure formulation that has shown greater bioavailability and improved administration than octreotide long-acting release (LAR) with a well-tolerated safety profile. Retrospective data have highlighted a potential benefit of high-exposure SRL for improved disease control in patients who did not adequately respond to the current SoC SRL treatment. This trial will investigate the efficacy and tolerability of CAM2029 compared to the current SoC, including octreotide LAR and lanreotide autogel (ATG). METHODS: SORENTO is a prospective, multicentre, randomised, active-controlled, open-label phase 3 trial aiming to demonstrate superiority of treatment with 20 mg octreotide subcutaneous depot (CAM2029) every 2 weeks (Q2W) compared to treatment with the Investigator's choice of SRL therapy at standard doses for tumour control (octreotide LAR 30 mg or lanreotide ATG 120 mg every 4 weeks [Q4W]) as assessed by progression-free survival (PFS) in approximately 300 patients with unresectable/metastatic and well-differentiated GEP-NET. Upon confirmation of disease progression (determined by a Blinded Independent Review Committee [BIRC] and defined as per RECIST 1.1), patients may enter an open-label extension treatment period with once weekly dosing, to investigate the effects of higher frequency dosing. Overall survival follow-up will end a maximum of 2 years after primary analysis. The primary endpoint will be analysed after 194 confirmed PFS events. DISCUSSION: This is the first trial investigating the efficacy of CAM2029 versus SoC SRL therapy using a head-to-head, superiority trial design. It is expected to be the first trial to investigate the efficacy of increased dosing frequency of a high-exposure SRL. A BIRC will limit bias and measurement variability and ensure high-quality efficacy data. Additionally, inclusion of patients with well-differentiated Grade 3 NET may elucidate treatment strategies for this rarely investigated patient population. TRIAL REGISTRATION: ClinicalTrials.gov NCT05050942. Registered on 21st September 2021.

Children and youth's perceptions of mental health-a scoping review of qualitative studies.

BACKGROUND: Recent research indicates that understanding how children and youth perceive mental health, how it is manifests, and where the line between mental health issues and everyday challenges should be drawn, is complex and varied. Consequently, it is important to investigate how children and youth perceive and communicate about mental health. With this in mind, our goal is to synthesize the literature on how children and youth (ages 10-25) perceive and conceptualize mental health. METHODS: We conducted a preliminary search to identify the keywords, employing a search strategy across electronic databases including Medline, Scopus, CINAHL, PsychInfo, Sociological abstracts and Google Scholar. The search encompassed the period from September 20, 2021, to September 30, 2021. This effort yielded 11 eligible studies. Our scoping review was conducted in accordance with the PRISMA-ScR Checklist. RESULTS: As various aspects of uncertainty in understanding of mental health have emerged, the results indicate the importance of establishing a shared language concerning mental health. This is essential for clarifying the distinctions between everyday challenges and issues that require treatment. CONCLUSION: We require a language that can direct children, parents, school personnel and professionals toward appropriate support and aid in formulating health interventions. Additionally, it holds significance to promote an understanding of the positive aspects of mental health. This emphasis should extend to the competence development of school personnel, enabling them to integrate insights about mental well-being into routine interactions with young individuals. This approach could empower children and youth to acquire the understanding that mental health is not a static condition but rather something that can be enhanced or, at the very least, maintained.

Interprofessional Teamwork to Promote Health: First-Time Parents' Experiences of a Combined Home Visit by Midwife and Child Health Care Nurse.

Background: To achieve the requisites for a child's healthy development and to reduce health inequalities, it is important to promote health initiatives at an early stage in a child's life and to include the parents. Home visits by healthcare professionals have been found to have positive health effects for both the baby and the parents. From an extended home visit programme in Sweden, our aim was to illuminate first-time parents' experience of a home visit conducted by a midwife and a child health care nurse 1-2 weeks postnatal. Methods: Data was collected by interviews (n = 13) with first-time parents. The transcribed texts were analyzed using inductive content analysis. Results: The participants' experiences could be understood from the two themes, A trust in the professionals and Feeling safe as a new parent. The participants experienced that the midwives and the child health care nurses complemented each other and appreciated to get knowledge and information from both professions. In their own home, they felt secured and relaxed, and the professionals could help them provide a safe home environment for the child. Conclusion: By meeting both professionals at the same time and in their own home, the participants experienced that the needs of the baby and their needs and concerns as new parents were included and supported.

Life Challenges and Barriers to Help Seeking: Adolescents' and Young Adults' Voices of Mental Health.

Listening to the voices of adolescents and young adults regarding their lived experiences could be a way to identify important skills and abilities for adaptive and positive behaviour that will enable youth to deal effectively with the demands and challenges of everyday life. Hence, the aim with the current study is to explore the experiences and understandings of the life situation among adolescents and young adults of today, by making their voices heard in regards to mental health and help-seeking behaviour. A total of 6 group interviews were conducted with 22 adolescents and young adults (13 girls and 9 boys) ages 17-25 (M = 18.6 years). Data analysis was conducted using qualitative content analysis and resulted in two categories and five subcategories. The first category, Life challenges, included views on the sources of mental health, how to manage different types of relationships, and thoughts on accepted ways to express mental health problems. The second category, The need of present adults, highlighted important aspects for seeking help, such as an expressed need to be seen and heard by adults including parents, school staff, and other professionals as well as a need for adults' increased availability. The challenges to students' well-being and mental health are many, and there are no simple solutions. Based on the results in this study, life skills training should include elements to enhance the development of individual coping strategies, to be applied when life feels tough and when the body is experiencing stress reactions. Further, to minimize the risk of self-stigma and the internalization of negative stereotypes and self-blame, life skills training should include elements to increase knowledge of structural factors that have effects on the life situation as well as parents, school personnel, and other important adults.

Views on Adolescents' Mental Health in Sweden-A Qualitative Study among Different Professionals Working with Adolescents.

Professionals who meet and work with adolescents hold important information and perspectives on adolescents' mental health that, in addition to the adolescents' voices, can shed light on complex issues. The aim was to explore professionals' views on what challenges they face and how they can strengthen today's adolescents' mental health. This study involves four group interviews, conducted in March and October of 2020, including professionals with different working backgrounds. Data were analyzed with a qualitative content analysis. Two categories emerged: navigating life arenas and support for mental health. The first category included the demanding aspects of school, the challenges of social media, and the professionals' thoughts on which pieces of mental health knowledge adolescents are lacking. The second category included what the professionals thought today's parents need to develop and do to best support their children. Moreover, self-critical views were expressed on which aspects the professionals could do better to improve adolescents' mental health. In conclusion, listening to professionals working with adolescents talk about adolescents' mental health gives important insights. According to the professionals, both adolescents and their parents need improved life skills, including a strengthened and empowered self-esteem as well as improved mental health literacy.

An Extended Home Visit Programme Within the Swedish Child Healthcare System for First-Time Parents in Scania, Sweden: A Study Protocol.

Background: The Swedish Child Healthcare (CHC) system aims to provide equal and fair health care for all children and families in Sweden. Currently in Sweden, the CHC offers every family two home visits during the child's 1st year of life. During 2019, an extended home visit programme, called Grow Safely, was started in the region of Scania for first-time parents. The aim of the extended home visit programme was to provide support for first-time parents in order to improve the overall health of the child and family and contribute to better conditions for equal health. Instead of two home visits during the 1st year, a subsample of first-time parents would receive six visits during the child's first 15 months. These six visits would be conducted by CHC nurses and social workers, midwives, and dental assistants. In the present paper, we describe a research project related to the regional extended home visit programme; the project aims to illuminate the experiences of the participants and to investigate the perceived benefits of the programme in relation to improved health, social and emotional interaction between parent and child, and attitudes toward authorities and surrounding society. Method/Analysis: In order to evaluate the introduction of the intervention, three qualitative interview studies and one quantitative study with follow-up questionnaires will be conducted. Since the research project also comprises studies focusing on the implementation and expectations of politicians, civil servants, organizational managers, and professionals working within the programme, interviews within these fields will be conducted. Discussion: Sweden has a well-established CHC programme, but improvements are always possible. Previous research has shown that home visits are an effective tool to improve both the child's physical and mental health as well as the parents' well-being. However, this kind of intervention involves a significant investment from all organizations involved in the home visits; hence, it is important that the intervention is evaluated. The research project described in the present paper intends to examine the impact of the intervention, and its findings will aid decisionmakers in determining the future of the home visit programme.

Adolescents' perception of gender differences in bullying.

Gender norms are normative societal expectations regarding the behaviors of girls and boys that can guide bullying behavior. As early adolescence is a time when peer relations become increasingly important, it is critical to understand the peer relationships of adolescents and what is considered gender non-confirming behavior. Therefore, the aim of this study is to analyze Swedish girls' and boys' perception of gender differences in bullying. Twenty-one Swedish adolescents (8 girls and 13 boys) took part in four focus group discussions separated by boys and girls. Data analysis was conducted using qualitative content analysis. "Expectations and needs to fit the norm" emerged as the main category as all categories emerging from the analysis related to boys' and girls' understandings of how expectations, strategies, expressions relating to bullying and the need to belong vary depending on gender. Further, girls and boys expressed admiration for each other's ways of coping with bullying indicating that also coping strategies are associated with expectations based on gender. For schools and adults to be better equipped to meet the needs of girls and boys and understand how these needs are expressed, adolescents voices regarding gender related bullying can be seen as helpful tools to develop strategies to work with gender norms and gender expectations. In light of the results of our study, schools may have work to do when it comes to the awareness of norms and attitudes and how they are expressed as these may be a foundation for bullying, among both staff and students.

Cyber bullying among children with neurodevelopmental disorders: A systematic review.

Children and young adults with neurodevelopmental disorders (ND) are at increased risk of bullying compared to typically developing peers. It is still unclear to what extent they are involved in cyber bullying. This systematic review aimed at studying the prevalence of cyber bullying as perpetrators, victims, or both ("bully-victims") among students with ND in a school setting and in need of special education. The Web of Science, Scopus, ERIC, PsycINFO, PubMED, and Cochrane databases were searched including a manual search of reference lists, until February 24, 2018. Eight studies conducted in Europe, North America, the Middle East, and Australia were included reporting a prevalence of cyber-victimization among students with ND of 0%-41%, a prevalence of cyber-perpetration of 0%-16.7%, and a prevalence of bully-victims of 6.7%. Three out of five studies using control groups showed that students with ND might be more involved in cyber bullying overall compared to typically developing students. Students in segregated school settings report slightly higher prevalence rates of cyber bullying compared to students with ND in inclusive school settings, especially among girls. When comparing prevalence rates among studies using the same definition, we found similar prevalence rates. There was a tendency towards students with ND being more involved in cyber bullying compared to typically developing students, but this needs to be confirmed in future studies that should include control groups with typically developing students as well as validated and standardized measurements of cyber bullying and ND diagnoses.

A Systematic Review of Polyvictimization among Children with Attention Deficit Hyperactivity or Autism Spectrum Disorder.

Children with Autism Spectrum Disorder (ASD) or Attention Deficit Hyperactivity Disorder (ADHD) have shown an increased risk for violence and victimization. However, research on exposure to multiple forms of victimization in different contexts are scarce. Hence, the current aim is to review the evidence about polyvictimization among children with ASD or ADHD. PsycInfo, ERIC, ERC, Scopus, and PubMed databases were systematically searched until 12 March 2019 to identify empirical studies with reported prevalence rates of at least four forms of victimization among children with ASD or ADHD. A total of 6/1300 articles were included in the review, ranging in sample sizes from 92 to 4114. The reported prevalence rates for polyvictimization were 1.8% and 23.1% for children with ASD and 7.3% for children with ADHD. The results emphasize the high prevalence of violence and victimization, including polyvictimization, among children with ASD or ADHD. Polyvictimization among children with ASD or ADHD is a highly under researched area. Significant knowledge gaps and important methodological considerations that provide important implications for future research include lack of information on cyber bullying, frequency or intensity of victimization, and the failure to include children as informants and to report health outcomes associated with polyvictimization.

Understanding and defining bullying - adolescents' own views.

BACKGROUND: The negative consequences of peer-victimization on children and adolescents are major public health concerns which have been subjected to extensive research. Given all efforts made to analyze and estimate the social and health consequences of peer-victimization, the adolescents' own experiences and understandings have had surprisingly little impact on the definition of bullying. Therefore, the aim of the current study is to explore adolescents' definitions of bullying. METHODS: A questionnaire study (n = 128) and four focus group interviews (n = 21) were conducted among students aged 13 and 15. First, gender and age differences were analyzed with respect to what behaviors are considered bullying (questionnaire data). Second, analysis of what bullying is (focus group interviews) was conducted using qualitative content analysis. RESULTS: The adolescents own understanding and definition of bullying didn't just include the traditional criteria of repetition and power imbalance, but also a criterion based on the health consequences of bullying. The results showed that a single but hurtful or harmful incident also could be considered bullying irrespective of whether the traditional criteria were fulfilled or not. Further, girls and older students had a more inclusive view of bullying and reported more types of behaviors as bullying compared to boys and younger students. CONCLUSIONS: The results of the current study adds to the existing literature by showing that adolescents consider the victim's experience of hurt and harm as a criterion for defining bullying and not only as consequences of bullying. This may be of special relevance for the identification and classification of bullying incidents on the internet where devastating consequences have been reported from single incidents and the use of the traditional criteria of intent, repetition and power imbalance may not be as relevant as for traditional bullying. It implies that the traditional criteria included in most definitions of bullying may not fully reflect adolescents' understanding and definition of bullying. Assessments of bullying behaviors that ask adolescents to strictly adhere to the traditional definition of bullying might not identify all adolescents experiencing peer victimization and therefore not provide estimates of prevalence rates reflecting adolescents' own understanding of bullying.