- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06297460
Adaptation of STEPPS Program for Addressing Emotional Dysregulation and Self-harming Behaviors in Penitentiary Centers
Adaptation of the Systems Training for Emotional Predictability & Problem Solving (STEPPS) Program for Addressing Emotional Dysregulation and Self-harming Behaviors in Penitentiary Centers in Catalonia
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Castellón
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Castellón De La Plana, Castellón, Spain, 12071
- Rosa
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Men or women deprived of liberty serving sentences in a penitentiary center in Catalonia.
- Presence of self-harming behaviors.
- Sufficient understanding and proficiency in Spanish to participate in the STEPPS program.
- Sufficient cognitive competence for study participation.
- Mental capacity to provide informed consent.
Exclusion Criteria:
- Inmates under security measures or classified in the first degree of treatment.
- Inmates with language difficulties.
- Presence of severe pathologies that may hinder study participation.
- Inmates with the possibility of imminent release, impending transfers to other penitentiary centers, or pending trial.
Study Plan
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 |
|---|---|
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Experimental: STEPPS program
The only condition is the experimental one.
Participants receive the STEPPS program
|
STEPPS is based on a cognitive-behavioral and skills training approach divided into three major components.
The first component (sessions: 1-2) teaches participants to replace misconceptions about the presented issues with greater awareness of thoughts, feelings, and behaviors that characterize them.
It also helps them identify their own thought patterns driving their behaviors.
The second (sessions 3-12) teaches skills to more effectively manage the cognitive and emotional effects of the issues, such as distancing, communication, challenging, distraction, and problem-solving.
The third component (sessions 13-19) teaches behavioral skills where participants are encouraged to master habits of healthy eating, sleep hygiene, regular exercise, leisure activities, health monitoring, self-harm prevention, and interpersonal effectiveness.
The therapeutic objectives of the three blocks are awareness of illness (1), emotional regulation (2), and behavioral regulation (3).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of emotional and behavioral disregulation of patients
Time Frame: Pre-intervention and inmediately after the intervention
|
Using the Longitudinal assessment of the severity of emotional and behavioral dysregulation (Borderline Evaluation of Severity Over Time, BEST) (Blum et al., 2002), a 15-item questionnaire with a 5-point Likert scale (1= none/very mild; 5= extremely) that assesses three areas: the intensity of thoughts and emotions, and negative and positive behaviors.
|
Pre-intervention and inmediately after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Type and levels of impulsivity of patients
Time Frame: Pre-intervention and inmediately after the intervention
|
The Barratt Impulsiveness Scale (BIS) (Barratt, 1959) is a self-report questionnaire designed to assess impulsiveness in different areas.
It consists of 30 items that are scored on a 4-point scale (from rarely or never (1) to always or almost always (4)).
The scale measures three aspects of impulsiveness: Attentional Impulsiveness, Motor Impulsiveness, and Non-Planning Impulsiveness.
|
Pre-intervention and inmediately after the intervention
|
|
Suicide risk of patients
Time Frame: Pre-intervention and inmediately after the intervention
|
Using the Beck Suicidal Intent Scale (SIS) (Beck et al., 1979) it is assessed the characteristics and likelihood of a suicide attempt in the present and the past.
It addresses circumstances during the attempt, attitudes towards life and death, thoughts before, during, and after the attempt, and substance use.
The questionnaire consists of 20 items rated on a 3-point scale (0 to 2).
|
Pre-intervention and inmediately after the intervention
|
|
Self-injury frequency, typology and funcionality of patients
Time Frame: Pre-intervention and inmediately after the intervention
|
Through Inventory of Statements About Self-injury (ISAS) (Klonsky & Glenn, 2009), a questionnaire that explores self-injurious behaviors and is divided into two sections.
The first section evaluates the presence and frequency of 13 different types of self-injuries, and the second section assesses the functionality of self-injurious behaviors on a 3-point Likert scale.
|
Pre-intervention and inmediately after the intervention
|
|
Degree of hopeless of patients
Time Frame: Pre-intervention and inmediately after the intervention
|
Using Beck Hopeless Scale (BHS) (Beck et al., 1974), a 20-item true/false scale that assesses individuals' feelings of hopelessness.
In this case, it evaluates three aspects of hopelessness: 1.
A person's expectations about life; 2. Their feelings about the future, and 3.
The loss of motivation.
|
Pre-intervention and inmediately after the intervention
|
|
Perceived level of feasibility by professionals
Time Frame: Pre-intervention and inmediately after the intervention
|
Feasibility is measured with the Feasibility of Intervention Measure (FIM) (Weiner et al., 2017), a measure that encompasses four items designed to measure the feasibility of the intervention, indicating the extent to which the intervention can be successfully executed within the system, using a 5-point Likert scale.
|
Pre-intervention and inmediately after the intervention
|
|
Perceived level of acceptability of the intervention by professionals
Time Frame: Pre-intervention and inmediately after the intervention
|
The Acceptability of Intervention Measure (AIM) (Weiner et al., 2017) assesses acceptability based on stakeholders' perceptions of the intervention's utility or satisfaction across four items on a 5-point Likert scale.
|
Pre-intervention and inmediately after the intervention
|
|
Satisfaction of the intervention by patients
Time Frame: Pre-intervention and inmediately after the intervention
|
The Client Satisfaction Questionnaire (CSQ) (Attkisson & Zwick, 1982; Larsen et al., 1979) is an eight-item questionnaire that assesses participants' overall satisfaction with the intervention received on a 4-point scale.
|
Pre-intervention and inmediately after the intervention
|
|
Perceived level of adequacy by professionals
Time Frame: Pre-intervention and inmediately after the intervention
|
Intervention Appropriateness Measurement (IAM) (Weiner et al., 2017) comprises four 5-point Likert scale items designed to explore the adequacy of the intervention, considering its perceived relevance or compatibility in the given context.
|
Pre-intervention and inmediately after the intervention
|
|
Barriers and facilitators detected by professionals that are influencing the implementation process - Quantitative information
Time Frame: Pre-intervention and inmediately after the intervention
|
Quantitative data about barriers and facilitators is gathered thrhough closed-open questionnaire was developed following CFIR guidelines (Damschroder et al., 2009), with reference to the study conducted by Hadjistavropoulos and colleagues (2017).
The final questionnaire comprised 41 items rated on a 5-point Likert scale (ranging from 1, strongly disagree, to 5, strongly agree), assessing: Intervention Characteristics (7 items), Outer Context (5 items), Inner Setting (14 items), Characteristics of Individuals (8 items), and Implementation Process (7 items).
|
Pre-intervention and inmediately after the intervention
|
|
Level of burnout of professionals
Time Frame: Pre-intervention and inmediately after the intervention
|
Using the Copenhagen Burnout Inventory (CBI) (Kristensen et al., 2005), a 19-item questionnaire on a 5-point Likert scale that measures burnout syndrome, differentiating three sub-dimensions: personal burnout, work-related burnout, and user-related burnout.
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Pre-intervention and inmediately after the intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Barriers and facilitators detected by professionals that are influencing the implementation process - Qualitative information
Time Frame: Inmediately after the intervention
|
Semi-structured interviews conducted to professionals guided by Consolidated Framework for Implementation Research (CFIR) (Damschroder et al., 2009). To guide the development of these analyses, the CFIR served as a framework, assisting in semi-structured interviews and formulating relevant questions based on the five domains that influence the implementation process: (1) Intervention Characteristics, (2) Outer Setting, (3) Inner Setting, (4) Characteristics of Individuals, and (5) Implementation Process (25,33). |
Inmediately after the intervention
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Black DW, Blum N, McCormick B, Allen J. Systems Training for Emotional Predictability and Problem Solving (STEPPS) group treatment for offenders with borderline personality disorder. J Nerv Ment Dis. 2013 Feb;201(2):124-9. doi: 10.1097/NMD.0b013e31827f6435.
- Black DW, Blum N, Eichinger L, McCormick B, Allen J, Sieleni B. STEPPS: Systems Training for Emotional Predictability and Problem Solving in women offenders with borderline personality disorder in prison--a pilot study. CNS Spectr. 2008 Oct;13(10):881-6. doi: 10.1017/s1092852900016989.
- Arnau F, Garcia-Guerrero J, Benito A, Vera-Remartinez EJ, Baquero A, Haro G. Sociodemographic, Clinical, and Therapeutic Aspects of Penitentiary Psychiatric Consultation: Toward Integration Into the General Mental Health Services. J Forensic Sci. 2020 Jan;65(1):160-165. doi: 10.1111/1556-4029.14137. Epub 2019 Jul 25.
- Brennan CA, Crosby H, Sass C, Farley KL, Bryant LD, Rodriquez-Lopez R, Romeu D, Mitchell E, House AO, Guthrie E. What helps people to reduce or stop self-harm? A systematic review and meta-synthesis of first-hand accounts. J Public Health (Oxf). 2023 Mar 14;45(1):154-161. doi: 10.1093/pubmed/fdac022.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STEPPSPENITENTIARY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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