Internet-assisted cognitive behavioural therapy with telephone coaching for anxious Finnish children aged 10-13 years: study protocol for a randomised controlled trial.

INTRODUCTION: Childhood anxiety is common, causes significant functional impairment and may lead to psychosocial problems by adulthood. Although cognitive behavioural therapy (CBT) is effective for treating anxiety, its availability is limited by the lack of trained CBT therapists and easily accessible local services. To address the challenges in both recognition and treatment, this study combines systematic anxiety screening in the general population with a randomised controlled trial (RCT) on internet-assisted CBT (ICBT) with telephone coaching. Child, family and intervention-related factors are studied as possible predictors or moderators, together with the COVID-19 pandemic. METHODS AND ANALYSIS: The study is an open two-parallel group RCT, stratified by sex, that compares ICBT with telephone coaching to an education control. Children aged 10-13 are screened at yearly school healthcare check-ups using five items from the Screen for Child Anxiety Related Disorders (SCARED) Questionnaire. The families of children who screen positive for anxiety are contacted to assess the family's eligibility for the RCT. The inclusion criteria include scoring at least 22 points in the 41-item SCARED Questionnaire. The primary outcome is the SCARED child and parent reports. The secondary outcomes include the impact of anxiety, quality of life, comorbidity, peer relationships, perceptions of school, parental well-being and service use. Additional measures include demographics and life events, anxiety disorder diagnoses, as well as therapeutic partnerships, the use of the programme and general satisfaction among the intervention group. ETHICS AND DISSEMINATION: The study has been approved by the research ethics board of the Hospital District of South West Finland and local authorities. Participation is voluntary and based on informed consent. The anonymity of the participants will be protected and the results will be published in a scientific journal and disseminated to healthcare professionals and the general public. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT03310489, pre-results, initially released on 30 September 2017.

Finnish Prenatal Study of Autism and Autism Spectrum Disorders (FIPS-A): overview and design.

This article presents an overview of the Finnish Prenatal Study of Autism and Autism Spectrum Disorders (FIPS-A), a new study designed to examine the relationship between prenatal serologic factors, mediating and moderating developmental antecedents, and risk of autism spectrum disorders (ASD). The FIPS-A is based on register linkages between births from 1987 to 2005 ascertained from the Finnish Medical Birth Register (FMBR) and other national registers on treatment for this group of disorders. All subjects were members of the Finnish Maternity Cohort (FMC), which consists of virtually all births in Finland from 1983 to the present, and which includes archived maternal serum samples. This study also capitalizes on other registry information, such as systematically collected data on pregnancy, prenatal and neonatal complications and manual data collection from well-child clinics providing developmental data from birth to the age of 7 years. In this paper, we describe the methods used in the FIPS-A study, including a description of the national registers, available data and case ascertainment procedures. Finally, we discuss implications of the data for future work on uncovering putative aetiologies of ASD and key strengths and limitations of the design.