Complex trauma psychoeducational intervention for female offenders

ISRCTN	ISRCTN35772940
DOI	https://doi.org/10.1186/ISRCTN35772940
Secondary identifying numbers	138344

Submission date: 07/10/2013
Registration date: 15/01/2014
Last edited: 14/04/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
We are carrying out a study to assess the effectiveness of psychoeducational interventions in female offenders with complex trauma. Our aim is to explore how effective a staged approach is to stabilising negative behaviours and trauma symptoms. We will want to look at a range of individual differences to see whether this has any impact on the outcome. The study's findings should help to improve the well-being of female offenders, particularly those in custody, as well as other survivors of trauma and abuse.

Who can participate?
Women, age 1870 years, who are currently in prison in Scotland and who have a history of abuse and trauma.

What does the study involve?
The participants will be randomly allocated either to a group-based intervention called Survive & Thrive or a waiting list group. Everybody on the waiting list will be offered a chance to participate in Survive & Thrive if they want to. Participants will be interviewed to assess their level of trauma as well as their experiences of abusive and adverse circumstances throughout their lives. The intervention consists of 10 sessions delivered over 5 weeks. Questionnaires are given at week 0, week 5 and at follow-up intervals at week 9 and 17 and should help record the progress participants make.
At the end of the study, we will compare the amount of behavioural change and other improvements in participants in both the intervention and waiting list groups.

What are the possible benefits and risks of participating?
There may be benefits to those taking part in the intervention. There will also hopefully be benefits to those female prisoners in the future because the results of the study are likely to help our understanding of appropriate treatment for female offenders and survivors of abuse in the future. The main risk of participating is that it could be upsetting for some women. Therefore, Survive & Thrive does not ask participants to talk about their own abusive experiences. Participants will also receive any further assistance from mental health staff should they need it.

Where is the study run from?
The study has been set up by Edinburgh Napier University in collaboration with the Scottish Prison Service. Participants will be recruited from HMP Cornton Vale and HMP Greenock, which are part of the Scottish Prison Service estate. The study will be conducted at HMP Cornton Vale, Scotland, UK.

When is the study starting and how long is it expected to run for?
The recruitment is expected to start in January 2014. Participants will be enrolled at various times over a period of two years.

Who is funding the study?
Survivor Scotland (UK).

Who is the main contact?
Mr Adam Mahoney, Adam.Mahoney@sps.pnn.gov.uk
Professor Thanos Karatzias, T.Karatzias@napier.ac.uk

Contact information

Mr Adam Mahoney
Scientific

Psychology Department
HMP Cornton Vale
Cornton Road
Stirling
FK9 5NU
United Kingdom

Email	Adam.Mahoney@sps.pnn.gov.uk

Study information

Study design	Randomized controlled trial and qualitative interviews
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The effectiveness of a Stage 1 psychoeducational intervention versus waiting list to stabilise complex interpersonal trauma symptomatology in female offenders
Study objectives	1. Is a Stage 1 psychoeducational intervention effective for the stabilisation of traumatic symptomatology in a prison setting? 2. Is a Stage 1 psychoeducational intervention acceptable to female offenders in a prison setting? 3. What are the factors that enhance the effectiveness and acceptability of such an intervention?
Ethics approval(s)	1. Scottish Prison Service, 13/06/2013 2. East of Scotland Research Ethics Service (EoSRES) REC 1, 15/11/2013, REC ref: 13/ES/0111
Health condition(s) or problem(s) studied	Interpersonal trauma
Intervention	Participants will be randomly allocated to either a treatment group (Survive & Thrive: Psychoeducational material for complex and interpersonal trauma) or a waiting list intent-to-treat group. Baseline assessments will assess trauma history and level of complex trauma symptomatology to establish eligibility. Baseline measures: 1. Traumatic Antecedents Questionnaire Revised version 3 (TAQ, van der Kolk, 2010) 2. Self-Report Instrument for Disorders of Extreme Stress (SIDES-SR: van der Kolk, 2002) 3. Young Schema QuestionnaireShort Form 3 (YSQ-S3: Young, 2005) A university-based statistician will assist with the randomisation of all eligible participants. Participants will be assessed blindly by the research assistant on four occasions: before treatment, post treatment as well as at 1 month and 3 months follow up. Therefore, the last assessment will be at week 17. Assessments will be conducted by means of standardised scales.
Intervention type	Other
Primary outcome measure	Behavioural Assessment Checklist measured at weeks 0, 5, 9 and 17
Secondary outcome measures	1. Difficulties in Emotional Regulation Scale (DERS; Gratz & Roemer, 2004). 2. Posttraumatic Stress Disorder (PTSD) Checklist Civilian Version (PCL-C: Blanchard et al., 1996) 3. The Dissociative Experiences Scale (DES II; Carlson & Putnam, 1993) 4. Hospital Anxiety and Depression Scale (HADS: Zigmond and Snaith, 1983) Measured pre and post intervention, and at 1 month and 3 months follow-up.
Overall study start date	01/01/2014
Completion date	01/03/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	92
Total final enrolment	44
Key inclusion criteria	1. Being willing to participate voluntarily and to give written consent 2. Having experienced childhood or adulthood negative life events 3. Aged 1870 years old 4. Being able to cope with the demands of the interviews
Key exclusion criteria	1. Unwilling to participate or unwilling to give written consent 2. Unable to cope with the demands of the interview because of mental or physical illness
Date of first enrolment	01/01/2014
Date of final enrolment	01/03/2018

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

HMP Cornton Vale

Cornton Rd
Stirling
FK9 5NU
United Kingdom

Sponsor information

Edinburgh Napier University (UK)
University/education

c/o Professor Thanos Karatzias
Head of Research Support
Sighthill Campus
Edinburgh
EH11 4BN
Scotland
United Kingdom

Website	http://www.napier.ac.uk
"ROR"	https://ror.org/03zjvnn91

Funders

Funder type

Charity

Survivor Scotland (UK) (Ref No. BPS/SPS 1)

No information available

Results and Publications

Intention to publish date	30/09/2019
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/07/2020	14/04/2021	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

14/04/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
20/03/2019: An intention to publish date has been added.