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

NCT06484205 | Recruiting

• 1 other identifier: Verbale n39
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver Burden

Keywords

psychosocial disabilities; caregivers; online training

Outcome Measures

Primary Outcomes (1)

• Improving the knowledge about human rights and the attitudes of caregivers towards people with psychosocial disabilities

  To evaluate it will be used: the World Health Organization's Knowledge about the Rights of persons with psychosocial disabilities questionnaire (16 items). It was developed by World Health Organization (WHO) to assess knowledge about the rights included in the United Nations Convention on the Rights of Persons with Disabilities (UN CRPD), and The World Health Organization's questionnaire on the attitudes towards people with psychosocial disabilities as rights-holders (17 items). It was developed by WHO and includes three sub-scales: attitudes towards institutionalization and living independently in the community; attitudes toward mandatory treatment and coercion; attitudes toward people with psychosocial disabilities as decision-makers.

  T0 (0 month), T1 (post intervention), T2; (3 months after post-intervention), T3 (6 months after post-intervention)

Secondary Outcomes (3)

• Change from Baseline to post intervention and to follow-ups of The Short Form Health Survey (Quality of life)

  T0 (0 month), T1 (post intervention), T2; (3 months after post-intervention), T3 (6 months after post-intervention)

• Change from Baseline to post intervention and to follow-ups of Patient Health Questionnaire-9 (Depressive symptoms)

  T0 (0 month), T1 (post intervention), T2; (3 months after post-intervention), T3 (6 months after post-intervention)

• Change from Baseline to post intervention and to follow-ups of Zarit Burden interview

  T0 (0 month), T1 (post intervention), T2; (3 months after post-intervention), T3 (6 months after post-intervention)

Study Arms (2)

WHO QualityRights e-training

EXPERIMENTAL

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.

Other: WHO QualityRights e-training

Emotional intelligence e-training

ACTIVE COMPARATOR

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

Other: Emotional intelligence e-training

Interventions

WHO QualityRights e-training 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.

WHO QualityRights e-training

Emotional intelligence e-training 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

Emotional intelligence e-training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cagliari: lead

Study Sites (1)

Azienda Ospedaliero Universitaria Cagliari

Cagliari, 09100, Italy

RECRUITING

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

Mauro G Carta, Md

CONTACT

070 51092158; maurogcarta@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a Randomized controlled clinical trial with four evaluation times (T0 pre- treatment; T1 post treatment; T2 3 months after T1 and T2 6 months after T1; aimed at evaluating the effectiveness of the World Health Organization QualityRights training compared to a control intervention (another online training program) in improving caregivers' human rights knowledge and attitudes towards people with psychosocial disabilities as rights holders.

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: June 26, 2024
• Primary Completion: June 26, 2025
• Study Completion: December 6, 2025
• Last Updated: July 19, 2024

Record last verified: 2024-07

Locations

IT (1)