Clinical trial NCT06255158: Pilot Randomized Controlled Trial of the INSIGHT Program
Official title: The Effectiveness of an Individualized Intervention for Perpetrators of Child Sexual Abuse
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Deviant Sexual Behavior
Keywords: effectiveness
RCT
child sexual abuse
schema therapy
Lead sponsor: University of Minho
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 30
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hanson Sex Attitude Questionnaire (HSAQ; Hanson et al., 1994; Portuguese version by Sousa et al., in press)
timeFrame: immediately post-intervention and 3-month follow-up
measure: Victim Empathy Distortion Scale (VES; Beckett & Fisher, 1994; Portuguese version: Sousa et al., in press)
timeFrame: immediately post-intervention and 3-month follow-up
measure: Basic Empathy Scale - Adapted (BES Adapted; Salas-Wright et al., 2012; Portuguese version: Pechorro et al., 2015).
timeFrame: immediately post-intervention and 3-month follow-up
measure: Rosenberg Self-Esteem Scale (RSES; Rosenberg, 1979, 1989; Portuguese version: Pechorro et al., 2011).
timeFrame: immediately post-intervention and 3-month follow-up
measure: Inventory of Interpersonal Problems (IIP-32; Barkham et al., 1996; Portuguese version by Faustino & Vasco, 2020).
timeFrame: immediately post-intervention and 3-month follow-up
measure: Young Schema Questionnaire - YSQ-S3 (Young, 2005; Portuguese version by Pinto-Gouveia, Rijo, & Salvador, unpublished).
timeFrame: immediately post-intervention and 3-month follow-up
measure: Brief Symptoms Inventory (BSI; Derogatis, 2001; Portuguese version: Canavarro, 2007).
timeFrame: immediately post-intervention and 3-month follow-up
measure: Sexual Violence Risk (SVR-20; Boer et al., 1997; Portuguese version: Gonçalves & Vieira, 2004).
timeFrame: immediately post-intervention and 3-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: University of Minho
Study officials:
References: