ISRCTN - ISRCTN35772940: Complex trauma psychoeducational intervention for female offenders

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mr Adam Mahoney

ORCID ID

Contact details

Psychology Department
HMP Cornton Vale
Cornton Road
Stirling
FK9 5NU
United Kingdom
Adam.Mahoney@sps.pnn.gov.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

138344

Study information

Scientific title

The effectiveness of a Stage 1 psychoeducational intervention versus waiting list to stabilise complex interpersonal trauma symptomatology in female offenders

Acronym

Study hypothesis

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

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

Study design

Randomized controlled trial and qualitative interviews

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

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 trial start date

01/01/2014

Overall trial end date

01/03/2018

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

92

Participant 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

Recruitment start date

01/01/2014

Recruitment end date

01/03/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Psychology Department
Stirling
FK9 5NU
United Kingdom

Sponsor information

Organisation

Edinburgh Napier University (UK)

Sponsor details

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