Filipa Sampaio

Suicide is the leading cause of death among 10–18-year-olds in Sweden. Suicide attempt is the most robust predictor of future attempts and suicide. Yet, no evidence-based treatment currently exists for preventing suicide reattempts. Safe Alternatives for Teens and Youths (SAFETY) is a novel scalable family-based cognitive-behavioural suicide prevention program designed to fill this critical gap. SAFETY has shown promise in reducing suicide attempts. In the present trial we aim to evaluate the effect of SAFETY on youth suicide attempts by comparing SAFETY to the active control condition “Enhanced Treatment as Usual” in a randomized clinical trial (RCT

N=282), recruiting from five sites across Sweden. The analyses will be conducted on an intention-to-treat basis. The primary outcome is the difference in the proportion of individuals with a new suicide attempt between the two groups at 3- (primary end-point) and 12-month post-treatment, analyzed using Pearson´s chi-squared test. Patients will be enrolled and treated between 2025 and 2027. Our initial findings from a feasibility RCT of SAFETY (N=30) in Stockholm indicate that our research protocol, including participant recruitment and treatment conditions, is feasible. The present study will investigate the impact of SAFETY on suicide attempts, evaluate the durability of the effects, and evaluate the cost-effectiveness of the intervention. The pilot and planning for the RCT have already been partially funded by other sources.

Research problem and specific questionsYoung children with subclinical neurodevelopmental disorders (NDDs) and concurrent emotional and behavioral problems (EBP) are at significant risk of negative consequences in the short and long term. Early parenting support interventions are recommended and requested. However, there is a lack of interventions specifically designed for this group and adapted to a Swedish context. Based on this gap, a parenting support intervention for parents with children 2-5 years of age with subclinical NDD and EBP has been co-created with clinicians and parents. The current project aims to evaluate the clinical- and cost-effectiveness of this parenting support group intervention.RQs Does the parenting support intervention “Everyday life and parenting” have a clinically significant effect on child behavior problems, parent self-efficacy, stress, well-being and quality of life and, if so, is this related to child type and level of NDD symptoms and family background factors?What are the trajectories of mental health and well-being of the children and their parents and how are they related to each other over time?Is the “Everyday life and parenting” intervention cost-effective? Data and methodThe study uses a multiple-baseline single-case experimental design (SCED) with pre- and, post- measures and a 3-month follow-up. Outcomes will include child emotional and behavioral problems and parent self-efficacy, stress, well-being, and quality of life, as well as costs for the intervention, health care use, and QALYs.Relevance and utilizationThe findings in this project will be of relevance for children with subclinical NDDs and their parents as well as health care organizations and the scientific community.  The intervention is well suited to the end users and the clinical context, as it has been co-created with clinicians and parents. It has the potential of being cost-effective as it builds on evidence-based components and existing resources.The suggested proposal is well suited to Forte’s areas of coordination on children and adolescents, specifically targeting the vulnerable group of young children with subclinical NDDs and their mental health.Project realizationThis 3-year project incorporates three studies which build a shared data collected in three waves. It is based on a well-established co-creation between the multidisciplinary research group and the clinical project group. A parent advisory board will be consulted throughout.

Research problem and specific questions: Disorders of Gut-Brain Interaction (DGBI) are a group of highly prevalent gastrointestinal disorders with large healthcare costs and high comorbidity with psychological distress. Even though psychological distress is an important factor in DGBI, most patients never receive psychological treatment. Acceptance and Commitment Therapy (ACT) is a theory-based intervention with demonstrated efficacy in numerous psychological and physical conditions, but lacks evidence in DGBI. This project aims to develop and test a self-guided online ACT intervention (iACTforDGBI) designed for people with DGBI and comorbid psychological distress.Data and method: This project includes 4 studies with different aims: Study 1 comprises the development of the iACTforDGBI intervention from previously tested interventions and focus group interviews. Study 2 tests the intervention’s acceptability and feasibility through a pilot study with 30 people with DGBI and 15 healthcare professionals, and will inform the refinement of the intervention. Study 3 evaluates its efficacy through a Randomized Controlled Trial with 276 people with DGBI and comorbid psychological distress. The intervention will be compared to an active control condition (online education on DGBI). Evaluation of efficacy will include changes in anxiety and depressive symptoms, quality of life, work absenteeism and presentism, gastrointestinal symptoms, and psychological flexibility from baseline to post-treatment and 6- and 12-months follow-up. Study 4 will evaluate the cost-effectiveness (evaluation of economic costs) of the intervention, based on the data collected in Study 3.Societal relevance and utilisation: This project aims at alleviating the burden associated with DGBI and the lack of access to mental healthcare faced by people with these disorders. Results will create opportunities for the implementation of the iACTforDGBI intervention in the usual healthcare of people with DGBI in Sweden, promoting their well-being and empowerment, and potentially decreasing costs.Plan for project realisation: This project will be conducted by a multidisciplinary team comprising psychologists (ACT researchers), a physician, a dietitian, a nurse, a health economist, and a qualitative researcher, all with previous experience in DGBI. Funds required include the services of a web development company, ACT therapists, costs for time and effort from the research team, and dissemination.

Research problemSweden makes major investments in universal child health and early education services. However, inequities in child health have increased. We propose that the reason for this paradox is that welfare services have failed to provide services proportionate to need

i.e. proportionate universalism (PU), to reduce differential exposure and differential vulnerability to health risks.The purpose of this research program is to examine the compensatory capacity of universal child health and early education services in Sweden and propose models for service provision according to the principles of PU.RQsIs PU practiced in Swedish child health services and do such practices impact children´s health (WP1)?Are there inequalities in the provision and utilization of child health services (CHS) and what health economic impacts would providing services according to PU have (WP2)?Is mapping preschool performance using the Early Development Instrument (EDI) feasible in the Swedish context and is it a potential planning tool for compensatory resource allocation (WP3)?Can the preschool’s compensatory task be improved in a co-designed manner together with structurally vulnerable children (WP4)?Data and methodWP1 Registry data on sociodemographics and child perinatal health will create a composite score for structural vulnerability

regional data will be used to assess CHS practice of PU through multilevel structural equation modelling

registry data will be used on child health outcomes.WP2 CHS provision in relation to SES stratification (the Winkler Index) will be examined using Benefit Incidence Analysis. Current versus ideal scenario of services with PU will be compared through a cost-utility framework to model health and economic outcomes at age 20, and a return-on-investment framework for returns at age 65.WP3 The EDI measures school readiness and is conceptualized as preschool performance in this proposal. A model for the use and necessary adaptations of the EDI in Sweden will be followed by a feasibility test and trialing scale-up. Co-design workshops will help develop the EDI for resource allocation.WP4 A toolkit to engage preschool-aged children in research will be developed and tested. Children will participate in ‘forum play’ to generate ideas for preschool compensatory activities, which will undergo participatory evaluation. The participatory process will be studied using behavioral observations.RelevanceThis proposal addresses four focus areas of the call aiming to generate equitable health and development for children in Sweden. By proposing co-designed ways to improve universal child health and early education services according to the principles of PU, results from this program can be implemented in national and local policies and practices.This 6-year program is built on four interrelated, yet independent WPs. Our multidisciplinary, applied research group Child Health And Parenting (CHAP) is complemented by experts in early education.

Research questionsPrimary: Does physical exercise have an effect on depression in adolescents?Secondary: Is there a correlation between changes in the degree of depression, in fitness and in strength towards biomarkers for neuroinflammation and neuroprotection? What is the cost-effectiveness compared with regular care? How are young people´s lifestyles affected by and how to increase adherence to exercise?Data and MethodMaterial: 122 adolescents with mild to moderate depression in CAMHS specialist care in Halmstad, Kungsbacka, Stockholm and Malmö who participated in at least three sessions and still depressed.Methods: Randomised multicenter study with active control group.Inclusion after psychiatric interview (K-SADS-PL) with psychiatrist. Control group with group leisure activity where the positive effect of social activation is controlled for. Measurement at baseline, after intervention at 3 months and at 6 months (RCT) and after one year (open phase) of investigator assessed depressive symptoms and function via interview CDRS-R and C-GAS, fitness via submaximal VO2 max test, three tests on muscle strength, nine biomarkers for neuroprotection and inflammation, questionnaire for cost assessment to parents and for quality of life to adolescents and qualitative interviews with both adolescents, parents and group leaders. Self-report of symptoms every two weeks during the intervention and every month thereafter.ImplementationGroup activity for 12 weeks with 60 minutes x3 per week of either physical exercise or calm leisure activity in a group. Training group with the same structure has been used for several years. Leisure group has been tested in a pilot study during 2021. Data collection via surveys is web-based. Interviews for depression and qualitatively takes place via video link to minimize the number of assessors and simplify for participants. A centre has experience in methods, weekly video link meetings with local monitors are planned for support in the implementation. Reliability in the primary outcome measure was good when co-estimating prior to the pilot study.RelevancePhysical exercise for depression in adolescents is promising but the quality of evidence is inadequate due to method shortcomings. Thus, National guidelines do not recommend physical exercise for depression. This RCT addresses the shortcomings in today´s knowledge base and can answer the question of whether group training should be included in care for young people with depression.

Research problem and specific questionsA stepped-care approach can lead to more effective care, reduced costs and work burden for mental health professionals. However, few models have been evaluated for children with externalizing behaviors (Oppositional Defiant Disorder, Conduct Disorder). These youth are at higher risk for continuous aggressive behaviors, academic failures, and mental health problems. Treatments mainly provide low to moderate treatment effects and the knowledge of change mechanisms is not satisfying, pointing towards a need for improved treatments. In this project, we aim to evaluate the effects, costs, scalability and acceptability of a stepped care model for families with a child with externalizing behaviors.Data and methodThis study uses a mixed-methods-design, with evaluations directly after treatment and after 6 months. The first step in the stepped care model is a digital parent intervention at selective-indicated preventive level (families with children 8-16 years at risk for/with oppositional, aggressive behavior

N=750) where an AB multiple baseline informs about changes over time. The second step is individual youth/parental treatment based on Cognitive Behavior Therapy (CBT) and virtual reality (VR) where families whose children still show signs of externalizing behaviors after the parent intervention are randomized to youth or parent CBT with/without VR. The evaluation will provide information on changes in children’s externalizing behaviors, well-being and parental strategies, as well as weekly measurements of change mechanisms will add to the understanding of factors contributing to change. We will also collect information on treatment costs and other societal resource use, and conduct interviews with children, parents and stakeholders for information about scalability and acceptability.Plan for project realisation Treatments are shaped in collaborations between researchers, families and clinicians. Parents will be recruited from child and adolescent psychiatry, primary care and through advertisements. Treatments will be managed by clinicians. Costs are necessary for a large treatment study. Relevance The study is expected to lead to new knowledge about effects and cost effectiveness of low- and highly intensive interventions for parents and youth, scalability of a digital parenting program, experiences and usefulness of VR in CBT, factors related to treatment effectiveness and societal use of a stepwise model.

Research problem / specific questions Autism Spectrum Disorders (ASD) are neurodevelopmental disorders associated with life-long struggles and high societal costs affecting about 2% of all children and adults. A large majority of young people with autism have comorbid mental disorders, such as obsessive-compulsive disorder (OCD), which are potentially treatable. However, these treatments are rarely available because they require access to highly specialised clinics. The families of children with ASD demand more access to treatment for these comorbidities. Access to specialist treatment could be improved dramatically if routine aspects of treatment could be digitalised. The overarching purpose of this project is to co-develop and evaluate the efficacy and cost-effectiveness of a novel digital intervention for OCD in young people with autism, and to follow through with a nationwide implementation of the intervention.  Data and method We propose to partner with patients, families, and clinicians to develop a novel digital intervention and evaluate its efficacy and cost-effectiveness in a fully powered multicentric (Stockholm, Lund, Gothenburg) randomised controlled trial (N=220), comparing our novel digital intervention with an active comparator. Next, we will implement the intervention in the national Stöd och Behandling digital platform and will conduct a real-world evaluation of the intervention in the same three clinics.  Plan for project realisation The project brings together a multidisciplinary team of researchers with a track record in child and adolescent psychiatry, clinical trials, digital interventions, biostatistics, health economics, and implementation science. The team also includes service users and patient organisations that will contribute with their lived experience, as well as health professionals.  RelevanceThis project originated as a direct response to a demand from families who have children with ASD. This will be the first properly powered trial of a digital intervention for a comorbid psychiatric disorder in autistic children anywhere, and the first to conduct a health economic evaluation. This will also be a rare example of national implementation of a digital intervention for youth with mental health problems and of a formal evaluation of the implementation. If successful, this project could represent a new model for the development and implementation of digital interventions for a broader range of comorbidities in youth with ASD.