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NCT ID: NCT05647499 Recruiting - Depression, Anxiety Clinical Trials

Evaluating the Back 2 School Program in a Norwegian Setting: A Multicenter Pilot Study

Start date: September 20, 2022
Phase: N/A
Study type: Interventional

The goal of this interventional pilot study is to gain experiences in using the Back 2 School (B2S) program for youth with school attendance problems in Norwegian community school- and health services. The main questions it aims to answer are: • What is the feasibility of the Back 2 School program when implemented in Norwegian community school- and health services? • What are the changes in school attendance rates, measures of psychological difficulties, and school related self-efficacy following the intervention? • How do participants experience the B2S program? 16 youth (6-16 years) with school attendance problems, their caregivers and the school participate in the B2S program provided by an interdisciplinary team during the school term of 2022-2023. Researchers will compare school attendance rates before entrance to the B2S program, at termination of the program and at 3-month follow-up. Also, researchers will compare reports on psychological difficulties, quality of life, and school related-self efficacy at baseline and after the intervention. Researchers investigate participants experiences with the program through qualitative interviews with youths, caregivers, teachers and service providers. The researchers further aim to prepare and establish resources and infrastructure for a large intervention study, and to establish a well-functioning cooperation between researchers, research organizations, and municipalities in different regions.

NCT ID: NCT05154019 Completed - Clinical trials for Mental Health Wellness 1

Managing Minds at Work: A Feasibility Pilot Trial

Start date: October 20, 2021
Phase: N/A
Study type: Interventional

This feasibility pilot cluster RCT aims to pilot and feasibility test an online training toolkit (Managing Minds at Work) for line managers to develop their knowledge and confidence in preventing work-related stress and promoting mental health at work. The setting is work organisations of different types and sectors across the Midlands region of the United Kingdom. Participants must have direct managerial or supervisor responsibilities for 3 or more staff members. The intervention consists of five modules of online learning: Looking after your own Mental Health; Designing and managing work to promote mental well-being; Management competencies to prevent work-related stress; Developing a psychologically safe work environment; Having conversations about mental health at work. Each module includes some descriptive content, interactive elements and opportunities for reflections, and take between 20-30 minutes to complete. Participating organisations will be allocated to either the intervention or control arm. A waiting list control will be used, with line managers in the control organisations starting the intervention 3-months after baseline. Data will be collected through online surveys with the intervention group at baseline, immediately post-intervention (around 6 weeks post baseline), 3-months follow-up and 6-months follow-up. Control group will complete the online surveys at baseline and 3-months (as they start the intervention) and immediately after completing the intervention. As a feasibility pilot study, analysis will be focused on acceptability of the intervention, feasibility of recruitment, retention and data collection, and estimating parameters for a larger trial. The primary outcome measure is line managers' confidence to create a mentally healthy workplace. The secondary outcomes line manger mental health knowledge, line manager workplace mental health literacy, line manager self-rating of behaviour. In addition, the direct reports of line managers will be invited to participate to assess the feasibility of collecting the outcome data related to: employee well-being, employee rating of line manager behaviour, employee sickness absence, employee productivity. A process evaluation will be conducted to assess intervention acceptability, usability, implementation and effectiveness. Qualitative data will be collected via module feedback forms and in-depth interviews with a sample of line managers from the intervention arm and stakeholders.

NCT ID: NCT04543097 Active, not recruiting - Clinical trials for Musculoskeletal Pain

Work And Vocational advicE Study - Effectiveness of Adding a Brief Vocational Support Intervention to Usual Primary Care

WAVE
Start date: December 23, 2020
Phase: N/A
Study type: Interventional

Maintaining the population's fitness for work is a priority for the UK Government. People with poor health often struggle at work and take sick leave. Work brings financial, social and health benefits. Few employees receive support to manage their health at work, known as vocational advice, so when their health affects work they visit their general practitioner (GP). The investigators have recently shown the benefits of providing vocational advice for adults consulting in primary care with musculoskeletal pain. The WAVE study research question is: in patients consulting in general practice who receive a fit note for time off work, does a brief vocational advice intervention lead to fewer days lost from work than usual primary care, and is it cost-effective? WAVE includes a feasibility phase to adapt a vocational advice intervention for a broader group of patients and test it in a small sample of patients; followed by a pragmatic, multi-centre, two-arm, parallel-group randomised (1:1) trial with internal pilot phase, mixed methods process evaluation and health economic analysis. Patients will be randomised to either (i) vocational advice intervention plus usual care, or (ii) usual care alone. The vocational advice intervention is designed as a stepped care model based on the principles of case management and delivered by trained Vocational Support Workers (VSWs). The investigators will also interview patients, General Practitioners (GPs), VSWs and employers to understand their views about the intervention and return to work. Participants in the trial will be followed-up over 6 months with fortnightly text messages and postal questionnaires at 6 weeks and 6 months.

NCT ID: NCT03382080 Completed - Mental Health Clinical Trials

A School-based Intervention Project to Increase Completion of Upper Secondary School in Norway

COMPLETE
Start date: February 1, 2016
Phase: N/A
Study type: Interventional

Drop out from upper secondary school represents a risk for the future health and wellbeing of young people. Strengthening of psychosocial aspects of the learning environment may be an effective strategy to promote completion of upper secondary school. The COMPLETE study is a school based cluster randomized controlled trial (RCT) evaluating two school-based interventions, namely the Dream School Program (DSP) and the Mental Health Support Team (MHST) among 1st grade upper secondary school students in four counties in Norway. The interventions aim to improve psychosocial learning environments and subsequently school achievements and decrease drop-out and absence. Specifically, the COMPLETE study will 1. Evaluate whether the DSP alone 1. increases completion 2. increases presence 3. improves school achievements 4. improves mental health and wellbeing 2. Evaluate whether the DSP and the MHST combined 1. increase completion 2. increase presence 3. improve school achievements 4. improve mental health and wellbeing The COMPLETE study will also evaluate the effect of the DSP and MHST combined and the DSP alone against secondary outcomes of school satisfaction and loneliness. 3. Evaluate through a process evaluation whether the interventions were implemented in line with guidelines for each of the interventions, and whether the degree of program fidelity has influenced the effect of the interventions on the primary and secondary outcomes.