Adaptation of STEPPS Program for Addressing Emotional Dysregulation and Self-harming Behaviors in Penitentiary Centers

March 6, 2024 updated by: Rosa Lorente, Universitat Jaume I

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

The overall objective of this study is to assess the feasibility, within the Penitentiary Centers of Catalonia, of adapting the STEPPS program for addressing and preventing emotional dysregulation and self-harming behaviors through an implementation study.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

50

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

    • Castellón
      • Castellón De La Plana, Castellón, Spain, 12071
        • Rosa

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

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
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.
Pre-intervention and inmediately after the intervention

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

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

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.

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 1, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 8, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

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)?

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

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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