Pilot Randomized Controlled Trial of the INSIGHT Program

February 2, 2024 updated by: Marta Sousa, University of Minho

The Effectiveness of an Individualized Intervention for Perpetrators of Child Sexual Abuse

This randomized controlled trial aimed to assess the efficacy of a new intervention program for perpetrators of child sexual abuse: the INSIGHT Program. The primary outcome measures to assessing INSIGHT effectiveness will include psychological symptoms, EMSs, cognitive distortions, interpersonal problems, self-esteem, victim empathy, and empathy, and sexual violence risk. Then, qualitative interviews will enable an in-depth examination of the therapeutic process and its effects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Perpetrators of CSA will be recruited from Portuguese Prisons. Potential participants who are likely to meet inclusion criteria will be identified and referred to study staff by prison members.

Participants who agreed to participate gave written informed consent, completed the baseline assessment, and were randomly assigned to treatment conditions (treatment and control groups) using a random number table by a research assistant who was blind to any information about each participant.

Besides baseline assessment, participants completed the post-treatment assessment (at the end of INSIGHT Program) and follow-up assessment (3 months after INSIGHT completion).

The program's structured and manualized design ensures integrity, at least partially.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Portugal
      • Braga, Portugal
        • University of Minho

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • male;
  • men with convictions of a sexual crime against a child

Exclusion Criteria:

  • men with cognitive disabilities;
  • men with psychotic symptoms;
  • men with higher traits of psychopathy;
  • men with addiction to alcohol/drugs;
  • men with convictions for child pornography and/or rape (i.e., adult victims)
  • men in prison less than 12 months since the beginning of the program
  • Female;
  • men having low risk of sexual recidivism

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: INSIGHT Program

The design of the INSIGHT Program aligns with RNR model, the principles of cognitive behavioral therapy, and schema therapy. The intervention comprises different phases, beginning with an initial individual motivation interview intervention, and followed by a CBT-structured, ST-inspired individual program.

The core of the intervention program consists of a manualized individual program comprising 25 weekly sessions, each lasting approximately 60 minutes.
Behavioral: INSIGHT Program

INSIGHT Program:

the program targets the reduction of EMSs' interference in social information processing, which may otherwise lead to the use of deviant behavior to fulfill emotional and sexual needs. Furthermore, the program has specific goals: (1) developing insight about the offense cycle; (2) fostering empathy for victims; (3) enhancing intimate and social/ interpersonal skills; (4) increasing emotional regulation skills.
Other: Treatment As Usual Group
TAU in Portuguese prisons is primarily aimed to increase educational and professional qualifications
Other: Treatment As Usual (TAU)
TAU in Portuguese prisons is primarily aimed to increase educational and professional qualifications

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hanson Sex Attitude Questionnaire (HSAQ; Hanson et al., 1994; Portuguese version by Sousa et al., in press)
Time Frame: immediately post-intervention and 3-month follow-up
The study protocol will include the Hanson Sex Attitude Questionnaire (HSAQ; Hanson et al., 1994; Portuguese version by Sousa et al., in press). The Portuguese version of HSAQ is a 38-items self-report measure designed to measure cognitive distortions about child sexual abuse and sexuality. Through a confirmatory factor analysis, it was possible to identify three independent factors, namely: Child as human beings (17 items), Sexual Drive (12 items), and Sexual entitlement (9 items). Each item is scored on a 5-point ordinal scale (1 = strongly disagree to 5 = strongly agree). The scale does not have a cutoff point, but higher scores indicated more cognitive distortions. In factor 1, scores can vary between 17 and 85, in factor 2 from 12 to 60 and in factor 3 from 9 to 45.
immediately post-intervention and 3-month follow-up
Victim Empathy Distortion Scale (VES; Beckett & Fisher, 1994; Portuguese version: Sousa et al., in press)
Time Frame: immediately post-intervention and 3-month follow-up
The study protocol will include the Victim Empathy Distortion Scale (VES; Beckett & Fisher, 1994; Portuguese version: Sousa et al., in press. VES is a 28-item questionnaire to assess the individual's understanding of the impact of offending on their victims. The Portuguese version of the scale has two factors: positive misattributions of pleasure in sexual abuse (18 items), and negative attributions of child sexual abuse (10 items). The scale does not have a cutoff point but higher scores on factor one indicated more cognitive distortions about child sexual abuse, while a higher score in factor 2 represents a greater awareness of the impact that the abusive situation has on their victim. The items are rated on a 5-point scale ranging from 0 (strongly disagree) to 4 (strongly agree). In factor 1, scores can vary between 18 and 90, in factor 2 between 10 and 50.
immediately post-intervention and 3-month follow-up
Basic Empathy Scale - Adapted (BES Adapted; Salas-Wright et al., 2012; Portuguese version: Pechorro et al., 2015).
Time Frame: immediately post-intervention and 3-month follow-up
The study protocol will include the Basic Empathy Scale - Adapted (BES Adapted; Salas-Wright et al., 2012; Portuguese version: Pechorro et al., 2015). The BES Adapted is a self-report measure with two dimensions: affective empathy which encompasses three items, and cognitive empathy which includes four items. Each item is scored on a 5-point ordinal scale (1 = strongly disagree to 5 = strongly agree). The scale does not have a cutoff point, but higher scores indicate greater empathy. In the "affective empathy" factor, scores can vary between 3 and 15, in the "cognitive empathy" factor between 4 and 20. The total score can vary between 7 and 35.
immediately post-intervention and 3-month follow-up
Rosenberg Self-Esteem Scale (RSES; Rosenberg, 1979, 1989; Portuguese version: Pechorro et al., 2011).
Time Frame: immediately post-intervention and 3-month follow-up
The study protocol will included the Rosenberg Self-Esteem Scale (RSES; Rosenberg, 1979, 1989; Portuguese version: Pechorro et al., 2011). RSES is a brief self-report scale that assesses self-esteem. Responses are coded on a 4-point scale ranging from 0 (strongly disagree) to 3 (strongly agree). the scale does not have a cutoff point, but higher results reveal higher levels of self-esteem. The total score can vary between 0 and 30.
immediately post-intervention and 3-month follow-up
Inventory of Interpersonal Problems (IIP-32; Barkham et al., 1996; Portuguese version by Faustino & Vasco, 2020).
Time Frame: immediately post-intervention and 3-month follow-up
IIP-32 is a self-report instrument that focuses on the assessment of eight interpersonal domains: domineering/controlling; intrusive-needy; self-sacrificing; overly accommodating; nonassertive; socially avoidant ; cold-distant; and vindictive/self-centered. It is composed by 32 items rated along a 5-point Likert type scale response. No normative data are available.
immediately post-intervention and 3-month follow-up
Young Schema Questionnaire - YSQ-S3 (Young, 2005; Portuguese version by Pinto-Gouveia, Rijo, & Salvador, unpublished).
Time Frame: immediately post-intervention and 3-month follow-up
The study protocol will include the Young Schema Questionnaire - YSQ-S3 (Young, 2005; Portuguese version by Pinto-Gouveia, Rijo, & Salvador, unpublished). The YSQ-S3 is a self-report questionnaire comprising 90 items. It measures 18 different EMS proposed by Young (1990) using a 6-point type scale (1 = completely untrue to me; 6 = to describe me perfectly). We generally consider any score of 3 or more on a schema to be meaningful. The total score can vary between 0 and 6.
immediately post-intervention and 3-month follow-up
Brief Symptoms Inventory (BSI; Derogatis, 2001; Portuguese version: Canavarro, 2007).
Time Frame: immediately post-intervention and 3-month follow-up
The study protocol will include the Brief Symptoms Inventory (BSI; Derogatis, 2001; Portuguese version: Canavarro, 2007). BSI is a 53-item self-report instrument that measures psychopathological symptoms during the previous 7 days, on a five-point scale (0 = not at all to 4 = extremely). The inventory was composed of nine dimensions: somatization, obsession-compulsion, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism. The cut-off point for the somatization scale is 0.6, for the obsessions-compulsions scale is 1.6, for the interpersonal sensitivity scale is 1.1, for the depression scale is 1.2, for the anxiety scale is 1.3, for the hostility scale is 1.1, for the phobic anxiety scale is 0.6, for the paranoid ideation scale is 1.3, and for the psychoticism scale is 0.9 (Canavarro, 2007). The total score can vary between 0 and 4.
immediately post-intervention and 3-month follow-up
Sexual Violence Risk (SVR-20; Boer et al., 1997; Portuguese version: Gonçalves & Vieira, 2004).
Time Frame: immediately post-intervention and 3-month follow-up
SVR-20 is a structured professional judgment assessment instrument intended for use with perpetrators of sexual crimes. The instrument contains 20 items that are considered risk factors for recidivism in sexual crimes. Professionals use clinical judgment and file information to rate each of the 20 items as either "not present", "possibly or partially present" or "present". The instrument contains three sections: psychosocial adjustment (7 items), sex offenses (7 items) and future plans (2 items). the scale does not have a cutoff point.
immediately post-intervention and 3-month follow-up

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minho

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UID/01662/2020
  • 2020.06634.BD (Other Grant/Funding Number: Portuguese Foundation for Science and Technology)

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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