Deviant Sexual BehaviorNCT06255158
Pilot Randomized Controlled Trial of the INSIGHT Program
A study testing INSIGHT Program and Treatment As Usual (TAU) in people with Deviant Sexual Behavior, run by University of Minho at 1 site in Portugal.
Trial summary
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… Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Deviant Sexual Behavior
- What is being tested?
- INSIGHT Program and Treatment As Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Oct 2022to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- male;
- men with convictions of a sexual crime against a child
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Deviant Sexual Behavior
- Being tested
- INSIGHT Program, Treatment As Usual (TAU)
- Keywords
- effectiveness, RCT, child sexual abuse, schema therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSIGHT ProgramBehavioural
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.
Treatment As Usual (TAU)Other
TAU in Portuguese prisons is primarily aimed to increase educational and professional qualifications
| Study group | Role | What they receive |
|---|---|---|
| INSIGHT Program | Experimental | 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. Receives: Behavioral: INSIGHT Program |
| Treatment As Usual Group | Other | TAU in Portuguese prisons is primarily aimed to increase educational and professional qualifications Receives: Other: Treatment As Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hanson Sex Attitude Questionnaire (HSAQ; Hanson et al., 1994; Portuguese version by Sousa et al., in press)
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.
Measured: immediately post-intervention and 3-month follow-up
Victim Empathy Distortion Scale (VES; Beckett & Fisher, 1994; Portuguese version: Sousa et al., in press)
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.
Measured: 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).
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.
Measured: immediately post-intervention and 3-month follow-up
Rosenberg Self-Esteem Scale (RSES; Rosenberg, 1979, 1989; Portuguese version: Pechorro et al., 2011).
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.
Measured: immediately post-intervention and 3-month follow-up
Inventory of Interpersonal Problems (IIP-32; Barkham et al., 1996; Portuguese version by Faustino & Vasco, 2020).
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.
Measured: immediately post-intervention and 3-month follow-up
Young Schema Questionnaire - YSQ-S3 (Young, 2005; Portuguese version by Pinto-Gouveia, Rijo, & Salvador, unpublished).
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.
Measured: immediately post-intervention and 3-month follow-up
Brief Symptoms Inventory (BSI; Derogatis, 2001; Portuguese version: Canavarro, 2007).
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.
Measured: immediately post-intervention and 3-month follow-up
Sexual Violence Risk (SVR-20; Boer et al., 1997; Portuguese version: Gonçalves & Vieira, 2004).
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.
Measured: immediately post-intervention and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Oct 2022
- Primary completion30 May 2023
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deviant Sexual BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Sousa, University of Minho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255158
- Sponsor's protocol ID
- UID/01662/2020
- Other IDs
- 2020.06634.BD
- Status last verified
- Feb 2024
- First submitted
- 16 Jan 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of an Individualized Intervention for Perpetrators of Child Sexual Abuse
- ClinicalTrials.gov ID
- NCT06255158
- Acronym / sponsor ID
- UID/01662/2020
- Conditions
- Deviant Sexual Behavior
- Keywords
- effectiveness, RCT, child sexual abuse, schema therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MinhoUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- Sep 2024 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INSIGHT Program | Experimental | Behavioral: INSIGHT ProgramThe 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. |
| Treatment As Usual Group | Other | Other: Treatment As Usual (TAU)TAU in Portuguese prisons is primarily aimed to increase educational and professional qualifications |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- male;
- men with convictions of a sexual crime against a child
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INSIGHT ProgramINSIGHT 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. | Behavioural | INSIGHT Program |
| Treatment As Usual (TAU)TAU in Portuguese prisons is primarily aimed to increase educational and professional qualifications | Other | Treatment As Usual Group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Deviant Sexual Behavior
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
RecruitingObservational study
Assessment of Female Sexual Function Index (FSFI) Scores at 1 Month After Endometrial Sampling Performed Under Sedo-Analgesia or Local Anesthesia
Female Sexual Dysfunction, Endometrial Sampling
Active, not recruitingObservational study
A Prospective Cohort Study on the Effect of Spinal Spinal Cord Injury on Sexual Function in Male Patients
Sexual Function Abnormal, Spinal Cord Injuries (SCI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INSIGHT Program and Treatment As Usual (TAU) in people with Deviant Sexual Behavior, run by University of Minho at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.