A Qualitative Mixed Methods Realist Evaluation of Safety Planning

May 19, 2023 updated by: King's College London

A Survivor Researcher-led Qualitative Mixed Methods Realist Evaluation of Safety Planning: a Recovery-orientated Mental Health Risk Management Intervention.

Safety Planning is a recovery-orientated approach to risk management within mental health context. This study wants to answer the question 'how, why, for whom and it what circumstances does safety planning work? It will do this by carrying out a realist evaluation to identify programme theories by conducting a three phase study, reviewing materials of a Safety Planning training course, interviewing service users, carers and mental health professionals who have attended the training course, and/or use safety planning tools and techniques, adopting theory from existing literature and adding evaluator's insider knowledge. This data will be used to describe programme theory of safety planning that can be applied across diverse mental health settings, including NHS inpatient and community, and is designed to be adopted across different contexts. It will use a realist methodology to understand how safety planning works to develop the skills needed to manage risks associated with mental health difficulties in ways which increase an individual's quality of life.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Mental health service users accessing a service from Norfolk & Suffolk NHS Foundation Trust, Carers (family members, friends) of someone accessing a service from NSFT and Mental Health practitioners.

Description

Inclusion Criteria:

  • Service user participants - must have direct lived experience of managing safety from risks associated with their mental health difficulties / have attended the safety planning recovery college course delivered within Norfolk & Suffolk NHS Foundation Trust (NSFT) / Be accessing a service from NSFT and have an identified care team, lead care professional and/or know how to access help and support.

Carer participants - have cared for someone who lived with risks associated with their mental health difficulties / have attended the safety planning recovery college course delivered by NSFT / know how to access emotional support should they require it during the study Mental health professionals - have either a) supported people in a professional capacity to manage risks associated with mental health difficulties, b) attended either the safety planning recovery college course (NSFT) OR a version of safety planning training delivered within NSFT c) have some responsibility for safety planning and risk management within the trust. MUST HAVE knowledge of how to access staff wellbeing and support systems for emotional support should they require it during the study.

Exclusion Criteria:

  • People under 16 years of age / people who are unable to communicate in English / people with no access to computer, internet or basic IT skills /

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Formal theory described which explains how, why, for whom and in what circumstances safety planning works.
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

May 16, 2027

Study Registration Dates

First Submitted

May 19, 2023

First Submitted That Met QC Criteria

May 19, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 19, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 293012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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