Optimizing indicated cognitive behavioral therapy to prevent child anxiety and depression: A cluster-randomized factorial trial.

Identifying effective components can lead to interventions that are less resource-intensive and better suited for real-world needs. In this 2×2×2 cluster-randomized factorial trial (clinicaltrials.gov NCT04263558), we investigated the effects of three components of an indicated, transdiagnostic CBT intervention for children: 1) Intervention Delivery Format (child group format versus a blended format with group sessions and automated web-based sessions), 2) Parental Involvement in the intervention (group-based versus psychoeducational brochure), and 3) a Measurement Feedback System (MFS; on versus off). The intervention was delivered at schools in a group-based format. The participants (N = 701 children) were school children (age 8-12 years) with elevated symptoms of anxiety or depression, and their parents. The main outcomes were self-reported (N = 633) and parent-reported (N = 725) symptoms of child anxiety and depression post-intervention. The secondary outcome was children's user satisfaction with the intervention. We did not find significant main or interaction effects of Delivery Format, Parental Involvement, or MFS on children's symptom levels. There were no significant effects on children's user satisfaction. Results were compatible with retaining the least resource intensive combination (i.e., blended format, parental brochure, no MFS) in an optimized intervention.

Guideline evaluation and implementation mechanisms in school health services (GuideMe): protocol for a hybrid randomized factorial trial.

BACKGROUND: Norwegian school health services received a national best-practice guideline in 2017. To promote healthy life skills and identify adolescents needing support, the guideline includes strong recommendations for individual consultations with all 8th graders and increased collaboration with schools. To help implement the recommendations, a blended implementation strategy (SchoolHealth) was co-created with school nurses, students, and stakeholders. SchoolHealth consists of three implementation elements: Digital dialog and administration tool (audit and feedback +), Dialog support (external consultation), and Collaboration materials (targeted dissemination). This hybrid study will test the main and combined effects of the elements on guideline fidelity and effectiveness. METHODS: The GuideMe study is a factorial cluster randomized controlled trial examining SchoolHealth's effectiveness on guideline fidelity and guideline effectiveness goals. Forty Norwegian secondary schools will be randomized to eight different combinations of the elements in SchoolHealth. Participants will include school nurses and school personnel from these schools, and 8th grade students (n = 1200). Primary outcomes are school nurses' fidelity to the guidelines and student's ability to cope with their life (i.e., health literacy, positive health behaviors and self-efficacy). Quantitative methods will be used to test effects and mechanisms, while mixed- and qualitative methods will be used to explore mechanisms, experiences, and other phenomena in depth. Participants will complete digital questionnaires at the start and end of the schoolyear, and after the consultation during the schoolyear. The study will run in two waves, each lasting for one school year. The multifactorial design allows testing of interactions and main effects due to equal distribution of all factors within each main effect. Sustainment and scale-up of optimized SchoolHealth elements using national infrastructure are simultaneously prepared. DISCUSSION: The study will investigate possible effects of the implementation elements in isolation and in combination, and hypothesized implementation mechanisms. In-depth study of user experiences will inform improvements to elements in SchoolHealth. The results will yield causal knowledge about implementation strategies and the mechanisms through which they assert effects. Mixed-methods will provide insights into how and when the elements work. Optimizing guideline implementation elements can support adolescents in a crucial life phase. TRAIL REGISTRATION: ISRCTN24173836. Registration date 8 August 2022.

Study protocol of a factorial trial ECHO: optimizing a group-based school intervention for children with emotional problems.

BACKGROUND: Youth mental health problems are a major public health concern. Anxiety and depression are among the most common psychological difficulties. The aim of this study is to evaluate an optimized version of a promising indicated group intervention for emotional problems. The program (EMOTION Coping Kids Managing Anxiety and Depression) targets school children 8-12 years with anxious and depressive symptoms and examines three factors. Factor 1 compares the standard EMOTION intervention delivered in 16 group-based sessions (Group), versus a partially-digital EMOTION intervention (DIGGI) delivered as eight group sessions and eight digital sessions. Both versions use virtual reality technology (VR) to improve behavioral experiments. Factor 2 compares parent participation in a 5-session parent group (high involvement) versus sharing information with parents via a brochure (low involvement). Factor 3 compares the use of a measurement and feedback system (MFS) designed to help group leaders tailor the intervention using feedback from children with no MFS. METHODS: Using a cluster-randomized factorial design, 40 schools across Norway will be randomized to eight different experimental conditions based on three, two-level factors. To assess internalizing symptoms in children, children and their parents will be given self-report questionnaires pre-, post-, and one year after intervention. Parents also report on demographics, user satisfaction, personal symptoms and perception of family related factors. Teachers report on child symptoms and school functioning. Group leaders and the head of the municipal services report on implementation issues. The primary outcomes are changes in depressive and anxious symptoms. Some secondary outcomes are changes in self-esteem, quality of life, and user satisfaction. Questions regarding the consequences of the COVID-19 pandemic are included. Treatment fidelity is based on checklists from group leaders, and on user data from the participating children. DISCUSSION: This study is a collaboration between three regional centers for child and adolescent mental health in Norway. It will provide knowledge about: (1) the effect of school-based preventive interventions on anxiety and depression in children; (2) the effect of feedback informed health systems, (3) the effect and cost of digital health interventions for children, and (4) the effect of parental involvement.