Pilot Randomized Controlled Trial of the INSIGHT Program

NCT06255158 | Active Not Recruiting

• 2 other identifiers: UID/01662/20202020.06634.BD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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, victim empathy, and empathy, and sexual violence risk. Then, qualitative interviews will enable an in-depth examination of the therapeutic process and its effects.

Conditions

Deviant Sexual Behavior

Keywords

effectiveness; RCT; child sexual abuse; schema therapy

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  immediately post-intervention and 3-month follow-up

Study Arms (2)

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.

Behavioral: INSIGHT Program

Treatment As Usual Group

OTHER

TAU in Portuguese prisons is primarily aimed to increase educational and professional qualifications

Other: Treatment As Usual (TAU)

Interventions

INSIGHT Program BEHAVIORAL

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.

INSIGHT Program

Treatment As Usual (TAU) OTHER

TAU in Portuguese prisons is primarily aimed to increase educational and professional qualifications

Treatment As Usual Group

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minho: lead

Study Sites (1)

University of Minho

Braga, Portugal

Location

MeSH Terms

Interventions

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 13, 2024
• Study Start: October 1, 2022
• Primary Completion: May 30, 2023
• Study Completion: September 1, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)