NCT06966180

Brief Summary

The aim of this study is to develop and evaluate the effectiveness of an alcohol-specific intervention program for adult individuals on probation who have problems related to alcohol use. The study was designed as a single-blind randomized controlled trial and was conducted at the Izmir Probation Directorate with a total of 115 participants, 58 in the intervention group and 57 in the control group. When comparing the results between the intervention and control groups, the Alcohol Intervention Program-which consisted of six structured sessions-was found to be effective in reducing participants' alcohol consumption and related problems, while also increasing their motivation for change. This research is significant as it represents the first intervention program developed specifically for alcohol use within the probation system. While existing interventions in both Turkey and abroad often focus on individuals who use illicit substances, alcohol-related problems are frequently overlooked. The results of this study aim to meet that systemic need. The Alcohol Intervention Program developed here can be integrated into routine practices within the scope of educational improvement programs in the probation system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 11, 2025

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

May 3, 2025

Last Update Submit

May 9, 2025

Conditions

Keywords

Alcohol UseAlcohol InterventionCriminal Justice SystemProbationPsychosocial InterventionRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Reduction in Alcohol Use (AUDIT Score)

    The primary outcome was the change in participants' alcohol consumption, measured by the Alcohol Use Disorders Identification Test (AUDIT). The AUDIT consists of 10 items with a total score range of 0 to 40. Higher scores reflect more severe alcohol use. The effectiveness of the Alcohol Intervention Program (AIP) was evaluated by comparing AUDIT scores at baseline and at the end of the study (Week 12, immediately after the last session). A significant reduction in scores indicated decreased alcohol use and fewer alcohol-related problems.

    From baseline to study completion (Week 12, immediately after completion of the 6-session program)

Secondary Outcomes (2)

  • Reduction in Alcohol-Related Problems (MAST Score)

    From baseline to study completion (Week 12, immediately after completion of the 6-session program)

  • Increase in Motivation to Change (SOCRATES Score)

    From baseline to study completion (Week 12, immediately after completion of the 6-session program)

Study Arms (2)

Alcohol Intervention Program (AIP)

EXPERIMENTAL

Participants received a structured Alcohol Intervention Program (AIP) consisting of six bi-weekly group sessions. The program was based on motivational interviewing and cognitive-behavioral strategies and aimed to reduce alcohol use and related problems while increasing motivation to change.

Behavioral: Alcohol Intervention Program (AIP)

Probation Only (No Psychosocial Intervention)

NO INTERVENTION

Participants in this group did not receive any intervention program during the study period. They continued with standard probation supervision without any additional psychosocial intervention components.

Interventions

A brief behavioral intervention consisting of six bi-weekly group sessions based on motivational interviewing and cognitive-behavioral strategies. The aim was to reduce alcohol use and related problems and increase motivation to change.

Alcohol Intervention Program (AIP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over 18 years of age
  • Willingness to participate in the study (providing informed consent)
  • Being literate
  • Being under probation supervision and experiencing problems related to alcohol use, such as:
  • Problematic alcohol consumption
  • Endangering traffic safety due to alcohol use
  • Committing an offense under the influence of alcohol

You may not qualify if:

  • Having a psychotic disorder
  • Use of any psychoactive or addictive substances other than alcohol
  • Currently receiving treatment for alcohol-related problems voluntarily and outside the scope of probation supervision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İzmir Probation Directorate

Izmir, 35380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AlcoholismAlcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Mine Pazarcıkcı, PhD

    Ege University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single-blind design; participants were not informed about group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to either the intervention or the control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 3, 2025

First Posted

May 11, 2025

Study Start

June 1, 2023

Primary Completion

November 1, 2023

Study Completion

May 11, 2024

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations