Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06317155
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-07
Brief Title:
Occupational Therapy for Children and Young People Who Self-harm A Qualitative Study
Sponsor:
Bournemouth University
Organization:
Bournemouth University
Study Overview
Official Title:
Occupational Therapy for Young People Who Self-harm A Qualitative Study to Understand the Experiences of Children Their Carers and Healthcare Professionals
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 persons 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 persons 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 persons carers 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 Universitys 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
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 persons 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 persons 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 persons carers 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 Universitys 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None