Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03885349
Other study ID # H1537520365110
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 4, 2019
Est. completion date December 30, 2025

Study information

Verified date December 2023
Source University of Valencia
Contact Elena Terreros, PhD
Phone +3463030607983918
Email elenaterreros@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Alcohol and/or drug abuse problems (ADAPs) have been consistently identified in the scientific literature as a risk factor of intimate partner violence against women (IPVAW). Around 50% of IPVAW offenders referred to batterer intervention programs (BIPs) have ADAPs. ADAPs are also one of the main predictors of BIPs dropout. In Spain, the majority of BIPs do not fit the intervention to specific needs or characteristics of IPVAW offenders, such as those with ADAPs. The aim of this research is to assess the effectiveness of a new motivational strategy adapted to IPVAW offenders with ADAPs, aiming to increase treatment adherence and to improve BIPs outcomes. The motivational strategy will include an individualized motivational plan (IMP) developed for each participant with ADAPs (IMP-ADAPs). In these IMPs one of the main aims will be to reduce alcohol and/or drug consumption. The current study will use a randomized control trial. Participants with ADAPs will be allocated to one of two treatment conditions: experimental condition: Standard batterer intervention program (SBIP) plus individualized motivational plan focused in ADAPs (SBIP+ ADAPs-IMP), and control condition: Standard batterer intervention program plus individualized motivational plan (SBIP+IMP). Primary/final outcomes will be recidivism and ADAPs reduction. Secondary/proximal outcomes will include treatment adherence related variables, violence related attitudes and attributions, self-control and psychological adjustment. Outcome variables will be assessed at baseline, at the end of the intervention, and at six months after the intervention will be finished.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 30, 2025
Est. primary completion date November 30, 2025
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Males convicted of IPV against their partner or ex-partner - Alcohol and/or drugs abuse problems Exclusion Criteria: - No current severe psychological disorders

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
SBIP+ ADAPs-IMP
Standard batterer intervention program plus Individualized Motivational Plans adapted to alcohol and/or drug abuse problems. The SBIP consist of 70 hr of a cognitive-behavioral intervention including discussion topics such as sexism, sex roles, and gender equality. The intervention phase consisted of six modules in which different intervention techniques were applied (i.e., group dynamics, roleplaying, videos, training in cognitive restructuring, emotion management skills). The IMP included a set of motivational strategies to increase treatment compliance and motivation for change and had four main strategies: (a) five individual motivational interviews, to identify IPV related personal goals and follow up their achievement (in this case, one of the goals has to be related to ADAPs); (b) three group sessions where participants share their goals; (c) therapists follow-up and reinforcement of participants' goals; and (d) use of retention techniques.
SBIP+IMP
Standard batterer intervention program plus Individualized Motivational Plans. The SBIP consist of 70 hr of a cognitive-behavioral intervention including discussion topics such as sexism, sex roles, and gender equality. The intervention phase consist of six modules in which different intervention techniques are applied (i.e., group dynamics, roleplaying, videos, training in cognitive restructuring, emotion management skills). The IMP include a set of motivational strategies to increase treatment compliance and motivation for change and has four main strategies: (a) five individual motivational interviews, to identify IPV related personal goals and follow up their achievement; (b) three group sessions where participants share their goals, explain their progress to the group, and receive feedback, support and advice from the group; (c) therapists follow-up and reinforcement of participants' goals; and (d) use of retention techniques.

Locations

Country Name City State
Spain Faculty of Psychology Valencia

Sponsors (2)

Lead Sponsor Collaborator
University of Valencia Ministerio de Sanidad, Servicios Sociales e Igualdad

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in alcohol abuse problems Alcohol Use Disorders Identification Test. Saunders, Aasland, Babor, De la Fuente, & Grant, 1993. Total scale range: 0-20 (Higher values indicate worse outcome). At baseline, at 12 months (end of intervention), and at 18 months (follow-up)
Primary Change in cannabis abuse problems Severity Dependence Scale. Gossop et al., 1995. Total scale range: 0-15 (Higher values indicate worse outcome). At baseline, at 12 months (end of intervention), and at 18 months (follow-up)
Primary Change in cocaine abuse problems Severity Dependence Scale. Gossop et al., 1995. Total scale range: 0-15 (Higher values indicate worse outcome). At baseline, at 12 months (end of intervention), and at 18 months (follow-up)
Primary Change in self-reported physical intimate partner violence against women Self-reported physical violence sub-scale from the Conflict Tacticts Scale. Straus, Hamby, Boney-McCoy y Sugarman, 1996. Total scale range: 0-72 (Higher values indicate worse outcome). At baseline, at 12 months (end of intervention), and at 18 months (follow-up)
Primary Change in self-reported psychological intimate partner violence against women Self-reported psychological violence sub-scale from the Conflict Tacticts Scale. Straus, Hamby, Boney-McCoy y Sugarman, 1996. Total scale range: 0-72 (Higher values indicate worse outcome). At baseline, at 12 months (end of intervention), and at 18 months (follow-up)
Primary Change in risk of recidivism The Spousal Assault Risk Assessment. SARA; Kropp y Hart, 2000. Total scale range: 0-40 (Higher values indicate worse outcome) At baseline, at 12 months (end of intervention), and at 18 months (follow-up)
Primary Police-reported recidivism Ministry of Home Affairs' monitoring system for IPV. This system includes information on further incidents of violence by individuals convicted of IPV and reported by any of the institutions involved in victim protection services. Recidivism will be considered to have occurred when this information appear in the system in the 6 months after completing the intervention. At 18 months (follow-up)
Secondary Therapeutic alliance Working Alliance Inventory Shortened Observer-rated version (WAI-O-S; Tichenor & Hill, 1989). Total scale range: 0-74 (Higher values indicate better outcome) 4 weeks after the first session of the intervention
Secondary Change in motivation Based on the transtheoretical model of change (Prochaska and DiClemente, 1982; Prochaska et al., 1992), therapists will rate participants' stage of change (pre-contemplation, contemplation, preparation, action, and maintenance). Total range: 1-5 (Higher values indicate better outcome). At baseline, at 6 months, and at 12 months (end of intervention)
Secondary Change in impulsivity Plutchik Impulsivity Scale; Plutchnik y Van Pragg, 1989. Total scale range: 11-44 (Higher values indicate worse outcome) At baseline and at 12 months (end of intervention)
Secondary Change in depressive symptomatology Spanish reduced version of the Center for Epidemiology Studies-Depression Scale; Herrero y Gracia, 2007. Total scale range: 7-28 (Higher values indicate worse outcome) At baseline and at 12 months (end of intervention)
Secondary Change in self-esteem Rosenberg Self-Esteem Scale. Rosenberg, 1965. Total scale range: 10-40 (Higher values indicate better outcome) At baseline and at 12 months (end of intervention)
Secondary Attributions of Responsibility Intimate Partner Violence Responsibility Atribution Scale. Lila, Oliver, Catalá-Miñana, Galiana y Gracia, 2014. Three sub-scales: responsibility attribution to the legal system (sub-scale range: 4-20), responsibility attribution to the victim (sub-scale range: 4-20), and responsibility attribution to the offender personal context (sub-scale range: 4-20). Higher values indicate worse outcome. At baseline and at 12 months (end of intervention)
Secondary Change in perceived severity of intimate partner violence against women Severity Perception of Intimate Partner Violence Against Women Scale. Gracia, García y Lila (2011). Total scale range: 8-80 (Higher values indicate better outcome) At baseline and at 12 months (end of intervention)
Secondary Change in acceptability of intimate partner violence against women Acceptability of Intimate Partner Violence Against Women Scale. Martín-Fernández, Gracia, Marco, Vargas, Santirso and Lila (2018). Total scale range: 0-40 (Higher values indicate worse outcome) At baseline and at 12 months (end of intervention)
Secondary Change in benevolent sexism Ambivalent Sexism Inventory. Glick y Fiske, 1996. Two sub-scales: Benevolent sexism (sub-scale range: 0-55) and Hostile sexism (sub-scale range: 0-55). Higher values indicate worse outcome At baseline and at 12 months (end of intervention)
See also
  Status Clinical Trial Phase
Completed NCT03165942 - Neuroendocrine Response to Oral Alcohol Administration Phase 1
Recruiting NCT05343039 - Technology Enhanced Adolescent Mental Health (TEAM) N/A
Active, not recruiting NCT04070521 - EEG Monitoring in the Emergency Department
Completed NCT03169244 - Buproprion for Binge Drinking Phase 2
Recruiting NCT05246202 - Personalized Feedback Intervention for Latinx Drinkers With Anxiety N/A
Completed NCT05036499 - PFI for Pain-Related Anxiety Among Hazardous Drinkers With Chronic Pain N/A
Recruiting NCT04368416 - Anxiety/Depression, Sleep and Alcohol in Elderly Anxiety/Depression, Sleep Disturbances and Alcohol Use Disorder in Elderly With Cognitive Complaints
Not yet recruiting NCT04557631 - Evaluation of the Threshold for the Interpretation of the Results of a Method for the Blood Determination of Phosphatidyléthanol
Terminated NCT00890149 - Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults Phase 2
Completed NCT02448134 - A Community-Based Strategy for Preventing Underage Drinking N/A
Completed NCT02681406 - Smartphone Based Continuing Care for Alcohol N/A
Completed NCT02179749 - Mifepristone Treatment of Alcohol Use Disorder Phase 2
Withdrawn NCT01847300 - cSBI-M for Young Military Personnel N/A
Withdrawn NCT01796158 - Pilot Test of Computerized MET to Reduce Adolescent Alcohol Use N/A
Withdrawn NCT01511679 - Brain-imaging and Adolescent Neuroscience Consortium N/A
Terminated NCT01408641 - Topiramate for Alcohol Use in Posttraumatic Stress Disorder N/A
Completed NCT01553136 - Varenicline Treatment of Alcohol Dependence in Smokers Phase 2
Withdrawn NCT01275391 - cSBIRT to Reduce Teen Tobacco, Alcohol and Drug Use Phase 1/Phase 2
Active, not recruiting NCT01539525 - Screening to Augment Referral to Treatment- Project START Phase 2
Completed NCT00907309 - Dental and Medical Office iMET to Reduce Teen Tobacco, Alcohol, and Drug Use Phase 1/Phase 2