An Evaluation of an Adapted STEPPS Group Within Forensic Services (STEPPS-HI)

January 6, 2021 updated by: Liz Collins, Sussex Partnership NHS Foundation Trust

Adapting the Systems Training and Emotional Predictability and Problem Solving Group (STEPPS) for Service Users With Complex Needs. A Pilot Evaluation of STEPPS High Intensity (STEPPS HI) Within Forensic Inpatient Services

The purpose of this study is to determine how effective the STEPPS-HI group is at improving emotional regulation skills in those with identified difficulties in this area within forensic inpatient services. In addition, to explore whether there is increased acceptability of the adapted STEPPS group (STEPPS-HI) for this client group.

Study Overview

Detailed Description

Systems Training for Emotional Predictability and Problem Solving (STEPPS) is a manualised group programme for people primarily with a diagnosis of Borderline Personality Disorder (BPD). Although, STEPPS groups have been run within prisons in USA, it has been less formally evaluated within forensic psychiatric settings except for Pipon-Young & Cole (2012). Taking the learning from these studies into account, significant adaptations to the current STEPPS manual are needed to increase the acceptability and applicability of the group within forensic settings.

Following the adaption of the STEPPS manual for a forensic inpatient population (STEPPS HI), this research aims to investigate how effective the group is at improving emotional regulation skills in those with identified difficulties in the area as well as whether there is increased acceptability of the adapted group for the participants. The outcome of the research is intended to provide feedback on the adaption of the STEPPS manual and also an evaluation of the revised programme.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • East Sussex
      • Hellingly, East Sussex, United Kingdom, BN20 4ER
        • Elizabeth Collins

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older.
  • To give informed consent to participate in the study.
  • Currently a resident in a low or medium secure unit.
  • Has been diagnosed as meeting DSM-IV criteria for a personality disorder at some stage in their mental health history.
  • Has identified difficulties with emotional regulation.
  • Be willing and have suitable abilities to participate in a group.
  • To be assessed by the clinical team as sufficiently psychologically robust to participate in the group and the research.

Exclusion Criteria:

  • Psychiatric/psychological or any other difficulties that would mean that participants could not give informed consent.
  • Intellectual/cognitive impairment which prohibits participants ability to consent or fully comprehend the study or study materials.
  • Non-English speakers as there is no provision for interpreters.
  • Unable to manage a group environment due to risk to self and others including bullying and violence (this will be assessed by the clinical and STEPPS-HI facilitation team.
  • No evidence of emotional regulation difficulties.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: STEPPS within forensic services.

Forensic inpatients attend the STEPPS-HI group. Consent will be obtained. Pre and post group psychometric questionnaires will be completed as well as each service user attending a short semi-structured interview following the conclusion of the group .

Primary nurse will fill in pre and post group questionnaires. Facilitators will complete short feedback forms each session and attend a focus group upon completion.

Psychology Assistants/Interns will collect records of self harm and violence/aggressive incidents for each service user as well as records of nursing observation level and leave status taken.

This study will focus upon delivering the STEPPs-HI group within Forensic Healthcare Inpatient Services.
Other Names:
  • STEPPS-HI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess change from baseline (start of group) on the Symptom Checklist-Revised (SCL-90-R), reassessing at end of group (26 weeks later).
Time Frame: Assess at baseline (start of group) and reassess end of group (26 weeks later)
To assess change from baseline (start of group) on the Symptom Checklist-Revised (SCL-90-R), reassessing at end of group (26 weeks later).
Assess at baseline (start of group) and reassess end of group (26 weeks later)
To assess change from baseline (start of group) on the Zanarini Rating Scale for Borderline Personality Disorder, reassessing at end of group (26 weeks later).
Time Frame: Assess at baseline (start of group) and reassess end of group (26 weeks later)
To assess change from baseline (start of group) on the Zanarini Rating Scale
Assess at baseline (start of group) and reassess end of group (26 weeks later)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Overt Aggression Scale (MOAS: Yudofsky, J. M. Silver, W. Jackson, J. Endicott, & D. W. Williams, 1986).
Time Frame: Assess at baseline (start of group) and reassess end of group (26 weeks later)
Modified Overt Aggression Scale (MOAS: Yudofsky, J. M. Silver, W. Jackson, J. Endicott, & D. W. Williams, 1986).
Assess at baseline (start of group) and reassess end of group (26 weeks later)
Circumplex of Interpersonal Relationships in Closed Living Environments (CIRCLE; Blackburn & Renwick, 1996).
Time Frame: Assess at baseline (start of group) and reassess end of group (26 weeks later)
Circumplex of Interpersonal Relationships in Closed Living Environments
Assess at baseline (start of group) and reassess end of group (26 weeks later)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of self-harm incidents as assessed by Sussex Partnership NHS Foundation Trust Incident Reporting System.
Time Frame: A record of self-harm incidents will be collected weekly from one month prior to the group starting, weekly through the group intervention (26 weeks) and then weekly for one month after the group has finished (at 30 weeks).
Data will be reviewed via assessing the Sussex Partnership NHS Foundation Trust Incident Reporting System. Key information will be extracted i.e. number of self-harm incidents within the time frames stated in the time frame section. An excel spread sheet to collect this information will be developed by the study's principal investigator and the data will be inputted into the spread sheet by the Psychology Interns. Data analysis (a paired-samples t-test) will be conducted to compare the mean rates of self-harm incidents pre-group and post group.
A record of self-harm incidents will be collected weekly from one month prior to the group starting, weekly through the group intervention (26 weeks) and then weekly for one month after the group has finished (at 30 weeks).
Number of violent incidents as assessed by Sussex Partnership NHS Foundation Trust Incident Reporting System.
Time Frame: A record of violent incidents will be collected weekly from one month prior to the group starting, weekly through the group intervention (26 weeks) and then weekly for one month after the group has finished (at 30 weeks).
Data will be reviewed via assessing the Sussex Partnership NHS Foundation Trust Incident Reporting System. Key information will be extracted i.e. number of violent incidents within the time frames stated in the time frame section. An excel spread sheet to collect this information will be developed by the study's principal investigator and the data will be inputted into the spread sheet by the Psychology Interns. Data analysis (a paired-samples t-test) will be conducted to compare the mean rates of violent incidents pre-group and post group.
A record of violent incidents will be collected weekly from one month prior to the group starting, weekly through the group intervention (26 weeks) and then weekly for one month after the group has finished (at 30 weeks).
Assessing research participants (service users) views regarding group content, via attendance at a semi-structured interview utilising thematic analysis to analyse the data gathered (Braun & Clarke, 2006).
Time Frame: This will be completed at the end of the group intervention (26 weeks) with service users being invited to attend a semi-structured interview.
Research participants will be invited to attend a 1-1 semi-structured interview to capture their views on group content, format, structure, process, non-attendance and drop-put rates. The qualitative data gathered will be analysed by the principal investigator using thematic analysis (Braun & Clarke, 2006).
This will be completed at the end of the group intervention (26 weeks) with service users being invited to attend a semi-structured interview.
Assessing research participants (group facilitators) views of the adapted group manual via attendance at a focus group, utilising thematic analysis to analyse the data gathered (Braun & Clarke, 2006).
Time Frame: This will be completed at the end of the group intervention (26 weeks) with group facilitators being invited to attend a focus group.
Research participants will be invited to attend a focus group to capture overall views on the adapted manual. The qualitative data gathered will be analysed by the principal investigator using thematic analysis (Braun & Clarke, 2006).
This will be completed at the end of the group intervention (26 weeks) with group facilitators being invited to attend a focus group.
Record of research participants (service users) observational levels as assessed by Sussex Partnership NHS Foundation Trust general, intermittent and within eyesight recording forms.
Time Frame: A record of observational level forms (general, intermittent and within eyesight) will be collected weekly from one month prior to group starting, weekly through group intervention (26 weeks) and then weekly for one month after the group has finished (at
Data will be reviewed via assessing the Sussex Partnership NHS Foundation Trust record of observational level forms (general, intermittent and within eyesight). Key information will be extracted i.e. changes within observational levels in the time frames stated in the time frame section. An excel spread sheet to collect this information will be developed by the study's principal investigator and the data will be inputted into the spread sheet by the Psychology Interns. The data gathered will be reported in the demographic section of the result within the journal article developed to disseminate the outcomes of the study.
A record of observational level forms (general, intermittent and within eyesight) will be collected weekly from one month prior to group starting, weekly through group intervention (26 weeks) and then weekly for one month after the group has finished (at
Record of leave status for each research participants (service user) as assessed by Sussex Partnership NHS Foundation Trust Mental Health Act 1983 - Section 17 Leave of Absence Forms.
Time Frame: A record of leave status will be collected weekly from one month prior to group starting, weekly through group intervention (26 weeks) and then weekly for one month after the group has finished (at 30 weeks).
Data will be reviewed via assessing Sussex Partnership NHS Foundation Trust Mental Health Act 1983 - Section 17 Leave of Absence Forms for each research participant. Key information will be extracted i.e. changes within level status in the time frames stated in the time frame section. An excel spread sheet to collect this information will be developed by the study's principal investigator and the data will be inputted into the spread sheet by the Psychology Interns. The data gathered will be reported in the demographic section of the result within the journal article developed to disseminate the outcomes of the study.
A record of leave status will be collected weekly from one month prior to group starting, weekly through group intervention (26 weeks) and then weekly for one month after the group has finished (at 30 weeks).

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Elizabeth R Collins, Sussex Partnership NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 6, 2021

Primary Completion (Actual)

January 6, 2021

Study Completion (Actual)

January 6, 2021

Study Registration Dates

First Submitted

October 26, 2015

First Submitted That Met QC Criteria

November 9, 2015

First Posted (Estimate)

November 10, 2015

Study Record Updates

Last Update Posted (Actual)

January 7, 2021

Last Update Submitted That Met QC Criteria

January 6, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPFT-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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