Brief Education Supported Treatment for adolescent borderline personality disorder
| ISRCTN | ISRCTN16862589 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16862589 |
| Secondary identifying numbers | 40236 |
- Submission date
- 28/01/2019
- Registration date
- 11/02/2019
- Last edited
- 22/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Current plain English summary as of 09/01/2020:
Background and study aims
This study investigates a brief intervention that aims to equip education professionals with the knowledge and skills to support pupils with symptoms of borderline personality disorder (BPD) who have self-harmed. Staff from participating schools and colleges will take part in a training workshop in preparation for co-delivering a series of 3 – 6 sessions to individual pupils from their institution together with a mental health professional. The intervention is designed to reduce BPD symptoms by decreasing the emotional instability at the heart of the disorder, both by: (a) delivering the key elements of evidence-based interventions for adolescent BPD at an early stage, before symptoms become entrenched, and (b) reducing the confusion and anxiety that often surrounds young people with BPD who have self-harmed by equipping education professionals with the knowledge and skills to support pupils with BPD.
Who can participate?
Young people aged 13-18 at participating schools/colleges with symptoms of BPD who have self-harmed
What does the study involve?
In the first stage of the study, the findings of existing research are used to refine the intervention and pilot it within schools and colleges. In the second stage, to test whether it is possible to evaluate the effects of the intervention in a fair and unbiased way in a future trial, participants are allocated at random to either receive the study intervention or standard care. All participants are offered an assessment of their mental health with a study research assistant on entry to the study and 12 and 24 weeks later. The results of the study are shared with participating schools and colleges and used to inform the design of a future study evaluating whether the intervention leads to improved outcomes for young people.
What are the possible benefits and risks of participating?
Eligible participants will have the opportunity to try out a new treatment designed to help them understand and cope with some of the things they have been finding difficult. However, because the BEST intervention is new, it is not known for sure that it will be helpful. The results of the study will be used to to improve the support available to other young people in the future. To thank participants for their time and effort, they will be given a £10 shopping voucher for each assessment they participate in. Some people can find talking about personal things difficult or upsetting. If a participant becomes upset whilst taking part in the research, a member of the team will stay with them until they feel better and make sure they know where to go for further support if they need it later.
Where is the study run from?
1. City College Norwich (UK)
2. East Coast College (UK)
3. Dereham Neatherd High School (UK)
4. Acle Academy (UK)
5. Catch 22 Include (UK)
6. East Norfolk Sixth Form (UK)
7. Hellesdon High School (UK)
8. Jane Austen College (UK)
9. Ormiston Victory Academy (UK)
10. Taverham High School (UK)
11. Thorpe St Andrew School (UK)
When is the study starting and how long is it expected to run for?
November 2018 to March 2021
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Brioney Gee
Brioney.gee@nsft.nhs.uk
Previous plain English summary:
Background and study aims
This study investigates a brief intervention that aims to equip education professionals with the knowledge and skills to support pupils with symptoms of borderline personality disorder (BPD) who have self-harmed. Staff from participating schools and colleges will take part in a training workshop in preparation for co-delivering a series of 3 – 6 sessions to individual pupils from their institution together with a mental health professional. The intervention is designed to reduce BPD symptoms by decreasing the emotional instability at the heart of the disorder, both by: (a) delivering the key elements of evidence-based interventions for adolescent BPD at an early stage, before symptoms become entrenched, and (b) reducing the confusion and anxiety that often surrounds young people with BPD who have self-harmed by equipping education professionals with the knowledge and skills to support pupils with BPD.
Who can participate?
Young people aged 13-18 at participating schools/colleges with symptoms of BPD who have self-harmed
What does the study involve?
In the first stage of the study, the findings of existing research are used to refine the intervention and pilot it within schools and colleges. In the second stage, to test whether it is possible to evaluate the effects of the intervention in a fair and unbiased way in a future trial, participants are allocated at random to either receive the study intervention or standard care. All participants are offered an assessment of their mental health with a study research assistant on entry to the study and 12 and 24 weeks later. The results of the study are shared with participating schools and colleges and used to inform the design of a future study evaluating whether the intervention leads to improved outcomes for young people.
What are the possible benefits and risks of participating?
Eligible participants will have the opportunity to try out a new treatment designed to help them understand and cope with some of the things they have been finding difficult. However, because the BEST intervention is new, it is not known for sure that it will be helpful. The results of the study will be used to to improve the support available to other young people in the future. To thank participants for their time and effort, they will be given a £10 shopping voucher for each assessment they participate in. Some people can find talking about personal things difficult or upsetting. If a participant becomes upset whilst taking part in the research, a member of the team will stay with them until they feel better and make sure they know where to go for further support if they need it later.
Where is the study run from?
1. City College Norwich (UK)
2. East Coast College (UK)
3. Dereham Neatherd High School (UK)
When is the study starting and how long is it expected to run for?
November 2018 to March 2021
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Brioney Gee
Brioney.gee@nsft.nhs.uk
Contact information
Scientific
Norfolk and Suffolk NHS Foundation Trust
80 St Stephens Road
Norwich
NR1 3RE
United Kingdom
 ORCID ID |
0000-0003-0781-7753 |
|---|---|
| Phone | +44 (0)1603 974701 |
| Brioney.gee@nsft.nhs.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Process of Care, Psychological & Behavioural, Complex Intervention |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | School |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Brief Education Supported Treatment (BEST) for adolescent borderline personality disorder: a feasibility study of delivery of specialised early intervention for borderline personality disorder through collaboration with education providers, incorporating a feasibility randomised controlled trial |
| Study acronym | BEST for adolescent BPD |
| Study hypothesis | The study hypothesis is that it will be feasible to implement the modified BEST intervention and evaluate its effectiveness and cost-effectiveness in a randomised controlled trial. |
| Ethics approval(s) | Yorkshire & The Humber - South Yorkshire Research Ethics Committee, NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, Tel: +44 (0)207 1048091, Email: nrescommittee.yorkandhumber-southyorks@nhs.net, 07/11/2018, ref: 18/YH/0416 |
| Condition | Borderline personality disorder (BPD) and self-harm |
| Intervention | This study investigates a brief intervention that aims to equip education professionals with the knowledge and skills to support pupils with symptoms of borderline personality disorder (BPD) who self-harm. Staff from participating schools and colleges will take part in a training workshop in preparation for co-delivering a series of 3 – 6 sessions to individual pupils from their institution together with a mental health professional. The intervention is designed to reduce BPD symptoms by decreasing the emotional instability at the heart of the disorder, both by: (a) delivering the key elements of evidence-based interventions for adolescent BPD at an early stage, before symptoms become entrenched, and (b) reducing the confusion and anxiety that often surrounds young people with BPD who self-harm by equipping education professionals with the knowledge and skills to support pupils with BPD symptoms. In the first stage of the study, the trialists will use the findings of existing research to refine the intervention and pilot it within schools and colleges. In the second stage, to test whether it will be possible to evaluate the effects of the intervention in a fair and unbiased way in a future trial, participants will be allocated at random to either receive the study intervention or standard care. Participants will be randomised in a 1:1 allocation ratio using pre-set lists of permuted blocks with randomly distributed block size. Randomisation will be stratified by school/college. The allocation sequence will be generated and managed remotely via a web-based system and will not be accessible by the research team, school/college staff or study participants. Young people aged 13-18 years with symptoms of BPD including self-harm will be invited to take part and, if they consent, will be screened to ensure the study is suitable for them. All participants will be offered an assessment of their mental health with a study research assistant on entry to the study and 12 and 24 weeks later. The results of the study will be shared with participating schools and colleges and will be used to inform the design of a future study evaluating whether the intervention leads to improved outcomes for young people. |
| Intervention type | Behavioural |
| Primary outcome measure | As this is a feasibility trial, the primary output will be the design of the subsequent definitive trial. A number of feasibility outcomes will be assessed to facilitate this output, including: 1. Recruitment rate: the ability to recruit participants to time and target 2. Retention rate: the ability to retain participants in the trial post randomisation, measured at 12 week and 24 week follow up 3. The ability of staff to deliver the intervention as intended, and the acceptability of the intervention from the perspective of staff and young people. Video/audio recordings of treatment sessions will be made and rated against the intervention adherence checklist. In-depth interviews will be conducted with a subsample of participants after the conclusion of their intervention to assess acceptability from the perspective of young people taking part and staff involved in intervention delivery will be invited to take part in focus groups at the end of each phase of the study. 4. The degree of contamination of the control arm, i.e. the extent to which participants randomised to the control arm receive elements of the trial intervention. Contamination will be assessed via staff logs of contact with control arm participants, observations within schools and colleges, in-depth interviews with a subsample of control arm participants, and staff focus groups 5. The acceptability and suitability of the proposed outcome measures. The rate of completion of each outcome measure at baseline, 12 and 24 weeks will be calculated. Qualitative information about acceptability of the measures will be gathered via in-depth interviews with participants. In addition, the usefulness of the EQ-5D-5L in adolescents with BPD symptoms will be explored by comparing EQ-5D-5L scores with other study outcome measures. |
| Secondary outcome measures | The proposed primary outcome measure for the definitive trial is severity of borderline personality features measured using the Borderline Personality Features Scale for Children (BPFS-C). In this feasibility trial, the BPFS-C will be administered at baseline, 12 and 24 weeks. In addition, the following data will be collected at baseline, 12 and 24 weeks: 1. Self-reported self-harm measured using the Risk Taking and Self Harm Inventory for Adolescents 2. Self-reported emotional dysregulation measured using the Difficulties in Emotion Regulation Scale 3. Perceived social support measured Childhood and Adolescent Social Support Scale 4. Time spent engaged in structured activity measured using the Time Use Survey 5. Health status measured using the EQ-5D-5L 6. Use of health and social care services measured using a modified version of the Client Service Receipt Inventory 7. School/college attendance and exclusions assessed using data on attendance and fixed-term and permanent exclusions collected by the participants school or college |
| Overall study start date | 01/11/2018 |
| Overall study end date | 31/03/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 66; UK Sample Size: 66 |
| Participant inclusion criteria | 1. Aged 13-18 years (school years 9-13) 2. Enrolled at a participating school/college 3. Score above 34 on the Borderline Personality Features Scale for Children 4. History of repeated self-harm assessed using the self-harm subscale of the Risk Taking and Self Harm Inventory for Adolescents (has intentionally harmed him/herself more than once) 5. Able to provide written informed consent or, for under 16s, written informed assent and parent/guardian consent |
| Participant exclusion criteria | 1. Currently receiving inpatient treatment or specific psychological intervention 2. Moderate/severe learning disability 3. Current psychotic disorder (those with sub-threshold psychotic symptoms will not be excluded) or substance dependence requiring care planned treatment (substance abuse will not be an exclusion criterion) |
| Recruitment start date | 01/01/2019 |
| Recruitment end date | 01/05/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Norwich
NR2 2LJ
United Kingdom
Great Yarmouth
NR31 0ED
United Kingdom
East Dereham
NR20 3AX
United Kingdom
Acle
Norwich
NR13 3ER
United Kingdom
Norwich
NR6 6HE
United Kingdom
Gorleston-On-Sea
Great Yarmouth
NR31 7BQ
United Kingdom
Norwich
NR6 5SB
United Kingdom
Norwich
NR3 1DD
United Kingdom
Norwich
NR5 0PX
United Kingdom
Norwich
NR8 6HP
United Kingdom
Norwich
NR7 0XS
United Kingdom
Sponsor information
Hospital/treatment centre
Hellesdon Hospital
Drayton High Road
Norwich
NR6 5BE
England
United Kingdom
| Phone | +44 (0)1603 421255 |
|---|---|
| RDOfficeMailbox@nsft.nhs.uk | |
"ROR" |
https://ror.org/03400ft78 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | The trialists plan to publish the study protocol. This is currently being prepared for publication. Findings will be disseminated to participants and other key stakeholders, including commissioners, CAMHS managers and service-users, academics and practitioners in mental health and education. Dissemination vehicles will include study newsletters, a dissemination event, publications in peer-reviewed journals and presentation at scientific conferences. We intend to publish the key study findings in a high-impact peer reviewed journal by the end of 2021. |
| IPD sharing plan | The datasets generated during the current study will be stored in a non-publically available repository on Norfolk and Suffolk NHS Foundation Trust’s electronic servers for a period of 10 years in accordance with the Trust’s research archiving policies. Data will be shared for future research if agreed by the Trial Management Group and subject to any necessary ethical or legal approvals. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/12/2022 | 22/03/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
22/03/2023: Publication reference added.
15/04/2020: Due to current public health guidance, recruitment for this study has been paused.
09/01/2020: The following changes have been made:
1. The trial participating centre Acle Academy has been added.
2. The trial participating centre Catch 22 Include has been added.
3. The trial participating centre East Norfolk Sixth Form has been added.
4. The trial participating centre Hellesdon High School has been added.
5. The trial participating centre Jane Austen College has been added.
6. The trial participating centre Ormiston Victory Academy has been added.
7. The trial participating centre Taverham High School has been added.
8. The trial participating centre Thorpe St Andrew School has been added.
9. The plain English summary has been updated to reflect the changes in trial participating centres.
08/01/2020: The following changes have been made:
1. The inclusion criteria 4. has been changed from "Current self-harm assessed using the self-harm subscale of the Risk Taking and Self Harm Inventory for Adolescents (has intentionally harmed him/herself more than once and at least on incidence of self-harm occurred during the past month)" to "History of repeated self-harm assessed using the self-harm subscale of the Risk Taking and Self Harm Inventory for Adolescents (has intentionally harmed him/herself more than once)".
2. The plain English summary has been updated so that the phrase "who self-harm" has been changed to "who have self-harmed" throughout.
3. The follow-up time listed in the interventions has been updated from 8 weeks to 12 weeks.
4. The follow-up time listed in the primary outcome measure has been updated from 8 weeks to 12 weeks.
5. The follow-up time listed in the secondary outcome measures has been updated from 8 weeks to 12 weeks.
6. The follow-up time listed in the plain English summary has been updated from 8 weeks to 12 weeks.
