Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06317155 |
Other study ID # |
BournemouthU-AS |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
December 2024 |
Est. completion date |
December 2025 |
Study information
Verified date |
March 2024 |
Source |
Bournemouth University |
Contact |
Andrew J Sweetmore |
Phone |
01202524111 |
Email |
asweetmore[@]bournemouth.ac.uk |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The goal of this qualitative observational study is to explore the experiences of children
and their carers, receiving occupational therapy for self-harm and the experiences of health
professionals delivering these interventions. The child cohort within the study will have a
history of self-harm and have been under the care of Children and Adolescent Mental Health
Services.
The main questions it aims to answer are:
- What are the experiences of children and their carers who have received occupational
therapy interventions as either a standalone, or adjunct, treatment for self-harm,
whilst under the care of Tier 4 CAMHS service.
- What are the experiences of healthcare professionals delivering occupational therapy
interventions working within a T4 CAMHS service.
- To understand the participants views on whether occupational therapy interventions are a
viable and effective approach to address self-harm amongst young people.
Participants will be asked to complete a questionnaire and take part in a single
semi-structured interview. 25% of participants may be asked to take part in a further in
depth semi-structured interview.
Description:
Study design:
This study will take a qualitative approach, utilising a reflexive thematic analysis for data
collection, coding and description of themes to provide a contextualised understanding of the
experiences of the participants to achieve the aims of the study. It will involve a
questionnaire, semi-structured interviews and possibly a further semi-structured interview
for some participants in order to gain a further data and a deeper understanding.
Participant recruitment:
The participants will be purposefully selected by the chief investigator, with reference to
the inclusion / exclusion criteria. Participant data will be sought from locally held
healthcare records. Access to these records will be sought post NHS Ethics and University
Ethics approval, and via the local NHS healthcare provider, with their agreement.
The young people and their carers will be invited to join the study by letter, one letter per
pair if they live in the same household. The letter will contain a participant information
sheet, containing a broad outline of the study. The letter will also contain a QR code which
will take them to an online site outlining further details of the study and should they wish
to take part in the study, a consent form to be signed by the carer only.
Healthcare professionals will be contacted via email. The letter will contain a participant
information sheet, containing a broad outline of the study. It will also contain a QR code
which will take them to an online site outlining further details of the study and should they
wish to take part in the study, a consent form to be signed.
All written communication will be written using HRA transparency wording.
Following confirmation and consent to join the study the chief investigator will contact the
participants via telephone or video call. The purpose of this step is to answer any questions
the participants may have with regards to the study, confirm contact details and for the
young person, to gain verbal consent to join the study. An individual safety protocol will be
discussed and co-created with the young person and their carer, which will outline the
measures in place with regards to managing any distress that may occur during the
questionnaire and subsequent interview, this will include signposting to services and
reference to any crisis plans that may already be in place.
Method:
Questionnaires:
Three separate online questionnaires will be created, tailored to the three categories of
participants. The questions will be focused on the experiences of the participants in
relation to either receiving or delivering a occupational therapy (OT) informed intervention.
A paper questionnaire can be provided if access to the internet is unavailable.
All necessary adjustments will be made to ensure that each participant is able to understand
and engage in the questionnaire, this may take the form of an 'easy read' version or a
questionnaire adapted for participants with vision or hearing impairment, for example.
There will be four key topics within the questionnaire, with no more than 4 questions per
topic (language of questions TBC):
Young people:
- Whether they found the occupational therapy (OT) informed interventions delivered during
their time under a T4 service helpful with managing thoughts or acts of self-harm / if
helpful or unhelpful why? / what did they like or dislike about the OT interventions? /
what could be different from their perspective?
- Whether they found the OT interventions better or worse when compared against standard
interventions for self-harm they may have received / better or worse in what way? / what
is good or bad about standard interventions?
- Whether they found OT interventions to be effective in empowering them to manage their
own mental health / more or less effective when compared to typical interventions? / did
it have any effect on the their confidence to manage thoughts or acts of self-harm? / As
a young person, would they have liked to take a greater or lesser role during the
interventions?
- General thoughts around the care they may have received from children and adolescent
mental health services / if liked or dislike, why? / what could be better or improved
upon? / If they could design a Child and Adolescent Mental Health Service (CAMHS)
service to support people who self-harm, what would it look like?
Carers:
- Whether they found the OTs interventions delivered under a T4 service helpful with
managing or reducing their young person's thoughts or acts of self-harm / if helpful or
unhelpful why? / what did they like or dislike about the OT interventions? / what could
be different from their perspective?
- Whether they found the OT interventions better or worse when compared against standard
interventions for self-harm they may have received / better or worse in what way? / what
is good or bad about standard interventions?
- Whether they found OT interventions to be effective in empowering the young person to
manage their own mental health / more or less effective when compared to typical
interventions? / did it have any effect on the young persons confidence to manage
thoughts or acts of self-harm? As a carer, would they have liked to take a greater or
lesser role during the interventions?
- General thoughts around the care they young person may have received from children and
adolescent mental health services / if liked or dislike, why? / what could be better or
improved upon from the perspective of a carer? / If they could design a CAMHS service to
support young people who self-harm, what would it look like?
Healthcare professional:
- What was their experience of helping to deliver OT informed interventions young people
who self-harm? How does this differ from the interventions you would typically deliver
to help support someone who self-harmed?
- Whether they found the OTs interventions delivered effective managing or reducing the
young person's thoughts or acts of self-harm / if helpful or unhelpful why? / what did
they like or dislike about the OT interventions? / what could be different from their
perspective?
- Whether they found OT interventions to be more effective in empowering the young person
to manage their own mental health compared to typical interventions? / better or worse
in what way? / did it have any effect on their confidence to manage thoughts or acts of
self-harm? / As a healthcare professional, would they have liked to take a greater or
lesser role during the interventions?
- General thoughts around the care they may have delivered to children and their carers as
part of child and adolescent mental health services / what could be better or improved
upon from the perspective of a staff member? / If they could design a CAMHS service for
young people who self-harm and their carers, what would it look like?
The questionnaires will contain no other questions with regards to self-harm or suicide.
Interviews:
The interviews will be conducted in either the young person's / carer's home, at an NHS venue
or online via a video call, at the preference of the participant.
If an NHS venue is requested this shall be organised by the chief investigator and will the
closest available one to the participant.
Before the interview starts, confirmation to proceed will be sought. The co-created safety
protocol will then be revisited with the young person, to confirm the procedures in place to
manage any potential distress during and after the interview. These procedures may include a
system to identify and communicate any distress experienced, either verbally or via emotion
cards, with the option of time out from the interview or stopping it.
At the conclusion of the interview the opportunity will be given to discuss how the interview
went and whether any further support may be required. This support may include signposting to
support services such as local and national mental health services and charities. Support may
also include reference to any CAMHS crisis plans that may already be in place.
If the interview takes place within an NHS venue then the safety plan will include discussion
of the fire procedure.
The interviews are expected to last for no longer than 60 minutes, for the young people the
interviews are likely to be around 30 minutes.
The semi-structured interview will follow on from the answers given within the questionnaire
and seek to draw out further information from the previous answers. The interviewed will
loosely adhered to an interview agenda to ensure each of these four key topics are addressed.
Discussions ay follow tangents which are interpreted to be meaningful to the interviewee and
may consider a variety of different topics, whilst still keeping within the intended
boundaries of the study.
The epistemic and ontological nature of the research objective and questions for this study
were conceived of, and will be conducted within, an analytical naturalist methodology, which
is akin to a paradigmatic framework consisting of elements of both constructivism and
essentialism, and experiential and critical, working along a continuum of these positions
with the intention to give equal prominence to all aspects of the knowledge sourced within
the interviews, seeking primarily to avoid the imposition of meaning onto the data.
A predominantly inductive approach to data interpretation will be taken, however a deductive
analysis of the participant data will occur to ensure that they data captured is relevant to
the research questions. In keeping with the methodology, latent and semantic coding will be
utilised.
This study will take place over a period of 12 months.
Data collection and storage:
Prior to beginning the study a data management plan will be created and agreed upon with the
study sponsor.
Questionnaires will be conducted using an online questionnaire platform. All interviews will
be recorded and transcribed using professional transcription software. In person interviews
will be recorded via electronic tape recorder. Online interviews will be recorded via the
video recording option on the application.
The data will be drawn from the platform and plotted onto spreadsheets or converted into data
files used within a data analysis platform, which in turn will be stored securely within
Bournemouth University's Microsoft OneDrive account, adhering to all relevant local and
national policies for data management and storage.
Any paperwork will be scanned, uploaded to the secure OneDrive folders, then destroyed.
Access to the OneDrive account will be limited to the chief investigator and study
researchers.
Reporting of adverse incidents:
Any adverse incidents which occur during participation within the study - either as a result
of, or separately during participation- will be documented as part of the study and will be
reported to both the university and healthcare provider, inline with local policies and
procedures.
Exactly one-month post-participation with the study the chief investigator will contact all
participants to check up on welfare post-participation and to document any adverse incidents
resulting from participation.
Any adverse incidents will be managed with reference to the co-created safety protocols.