NCT03885349

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2019

Completed
27 days until next milestone

Study Start

First participant enrolled

March 4, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

6.7 years

First QC Date

February 5, 2019

Last Update Submit

December 5, 2023

Conditions

Keywords

Intimate partner violenceAlcoholDrugBatterer intervention programs

Outcome Measures

Primary Outcomes (7)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (9)

  • Therapeutic alliance

    4 weeks after the first session of the intervention

  • Change in motivation

    At baseline, at 6 months, and at 12 months (end of intervention)

  • Change in impulsivity

    At baseline and at 12 months (end of intervention)

  • Change in depressive symptomatology

    At baseline and at 12 months (end of intervention)

  • Change in self-esteem

    At baseline and at 12 months (end of intervention)

  • +4 more secondary outcomes

Study Arms (2)

SBIP+ ADAPs-IMP

EXPERIMENTAL

Experimental condition: Standard batterer intervention program (SBIP) plus individualized motivational plan (IMP) focused in alcohol and/or drugs abuse problems (ADAPs).

Behavioral: SBIP+ ADAPs-IMP

SBIP+IMP

ACTIVE COMPARATOR

Control condition: Standard batterer intervention program plus individualized motivational plan (SBIP+IMP)

Behavioral: SBIP+IMP

Interventions

SBIP+ ADAPs-IMPBEHAVIORAL

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+ ADAPs-IMP
SBIP+IMPBEHAVIORAL

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.

SBIP+IMP

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males convicted of IPV against their partner or ex-partner
  • Alcohol and/or drugs abuse problems

You may not qualify if:

  • No current severe psychological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Psychology

Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

AlcoholismSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Marisol Lila, PhD

    University of Valencia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2019

First Posted

March 21, 2019

Study Start

March 4, 2019

Primary Completion

November 30, 2025

Study Completion

December 30, 2025

Last Updated

December 6, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations