Evaluation of the Effectiveness of the World Health Organization QualityRights Training in Italy

NCT ID: NCT06484205

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-26
• Study Completion Date: 2025-12-06

Brief Summary

The research aims to promote human rights of people with psychosocial disabilities. The design will be a randomized controlled trial (RCT) with two groups. The intervention will consist of participation in an online training, with a central focus on the human rights of people with psychosocial disabilities. The measured outcomes will be knowledge of human rights, caregivers' attitudes towards people with psychosocial disabilities as rights holders, caregiver burden, depressive symptoms, and quality of life.

Detailed Description

Throughout the world, people with psychosocial disabilities are frequently exposed to human rights violations, such as discrimination and exclusion from society, inability to access health services, physical, sexual and psychological abuse, violence, neglect and denial of the right to legal capacity.

Another obstacle to access to care, to social inclusion and which encourages violations of the human rights of people with psychosocial disabilities is represented by the stigma and discrimination it entails.

Furthermore, caregivers themselves can also be the recipients of stigma, and previous research suggests it affects more than half of them.

This stigmatization represents a real burden, especially in emotional terms, for caregivers and can reduce access to support, resources and opportunities in the social sphere with an impact that also has repercussions on the person with psychosocial disabilities for whom they take care. treatment.

The importance of providing positive support to caregivers in their supporting role emerges; an increasingly broad evidence base underlines the benefits of caregiver involvement on the well-being of their family member, in particular it is associated with an improvement in the quality of life, a reduction in symptoms, the risk of relapses and hospital admissions.

In this context, Internet-based interventions can be a useful tool to increase the knowledge of caregivers of people with psychosocial disabilities and to reduce the physical and psychological consequences resulting from burden and stigma.

The implementation of a mental health human rights literacy intervention among caregivers is of crucial importance in the current context. This type of initiative aims to provide caregivers with the knowledge and skills needed to understand, respect, defend and promote the human rights of people with psychosocial disabilities and can help caregivers identify situations where the rights of people with psychosocial disabilities could be violated. Such action can contribute to the empowerment of caregivers and people with mental health conditions and can help combat the stigma and discrimination associated with mental disorders.

The specific objective of the research is to conduct a randomized controlled trial in Italy to evaluate the effectiveness of the World Health Organization QualityRights training compared to a control intervention (another online training program) in improving human rights knowledge and caregivers' attitudes towards people with psychosocial disabilities as rights holders.

Conditions

Caregiver Burden

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

WHO QualityRights e-training

Participants assigned to the intervention group (n 40) will participate in the WHO QualityRights (QR) online training course on "Mental Health, Recovery and Community Inclusion". The QR training aims to increase knowledge of the rights of people with psychosocial disabilities and to change negative attitudes towards them and their role as rights holders.

Group Type: EXPERIMENTAL

WHO QualityRights e-training

Intervention Type: OTHER

WHO QualityRights training provides the necessary skills to support people with psychosocial disabilities in advocating for their rights. The QualityRights online course includes six main modules: 1) Human Rights; 2) Human rights, mental health and disability; 3) Legal capacity and the right to decide; 4) Stop coercion, violence and mistreatment; 5) Quality services and inclusion in the community; 6) Mental health, well-being and recovery and it will take approximately 8 hours for completion. QualityRights course modules can be completed at each participant's pace and needs. The training is considered concluded once the quizzes provided at the end of each of the six modules have been successfully completed and upon completion of the course it will be possible to download your official WHO certificate from the QR platform.

Emotional intelligence e-training

Participants assigned to the control group (n 40) will receive the online "Emotional Intelligence Training for Informal Caregivers" offered by PeerCare.

Group Type: ACTIVE_COMPARATOR

Emotional intelligence e-training

Intervention Type: OTHER

This course offers caregivers resources and knowledge so that they are able to manage their emotions and gain quality in the care they provide to others and in their own lives. The course duration is similar to that of the QualityRights online course and is intended for caregivers of people with disabilities and others interested

Interventions

WHO QualityRights e-training

WHO QualityRights training provides the necessary skills to support people with psychosocial disabilities in advocating for their rights. The QualityRights online course includes six main modules: 1) Human Rights; 2) Human rights, mental health and disability; 3) Legal capacity and the right to decide; 4) Stop coercion, violence and mistreatment; 5) Quality services and inclusion in the community; 6) Mental health, well-being and recovery and it will take approximately 8 hours for completion. QualityRights course modules can be completed at each participant's pace and needs. The training is considered concluded once the quizzes provided at the end of each of the six modules have been successfully completed and upon completion of the course it will be possible to download your official WHO certificate from the QR platform.

Intervention Type: OTHER

Emotional intelligence e-training

This course offers caregivers resources and knowledge so that they are able to manage their emotions and gain quality in the care they provide to others and in their own lives. The course duration is similar to that of the QualityRights online course and is intended for caregivers of people with disabilities and others interested

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• people aged 18 or over;
• caregivers of people with psychosocial disabilities relating to local mental health services;
• italian speaking people

Exclusion Criteria

• individuals under 18 years of age;
• people who have already participated in the WHO QualityRights online course.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Cagliari

OTHER

Sponsor Role: lead

Responsible Party

Mauro Giovanni Carta

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Azienda Ospedaliero Universitaria Cagliari

Cagliari, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Mauro G Carta, Md

Role: CONTACT

maurogcarta@gmail.com

070 51092158

Facility Contacts

Mauro G Carta, MD

Role: primary

maurogcarta@gmail.com

070 51092158

Carta

Role: backup

Other Identifiers

Verbale n39

Identifier Type: -

Identifier Source: org_study_id