NCT05878743

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
12mo left

Started Apr 2024

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Apr 2024May 2027

First Submitted

Initial submission to the registry

May 19, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2027

Expected
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

2.1 years

First QC Date

May 19, 2023

Last Update Submit

May 19, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Formal theory described which explains how, why, for whom and in what circumstances safety planning works.

    two years

Interventions

Developing the skills to manage risks associated with mental health difficulties in ways which increase personal recovery for individuals.

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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 /

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Health Risk Behaviors

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2023

First Posted

May 26, 2023

Study Start

April 1, 2024

Primary Completion

April 30, 2026

Study Completion (Estimated)

May 16, 2027

Last Updated

May 26, 2023

Record last verified: 2023-05