Alcohol Use DisorderPROB-AIPNCT06966180
Development and Effectiveness of an Alcohol Intervention Program for Adults Under Probation
A study testing Alcohol Intervention Program (AIP) in people with Alcohol Use Disorder and Problem Drinking, run by Mine Pazarcikci at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Problem Drinking, Psychosocial Intervention
- What is being tested?
- Alcohol Intervention Program (AIP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 11 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Evaluation of the Effectiveness of an Alcohol Intervention Program for Adults on Probation: A Randomized Controlled Trial
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.
Read the detailed description
This study aimed to develop and evaluate the effectiveness of a structured Alcohol Intervention Program (AIP) for adults under probation who experience alcohol-related problems. The research was designed as a single-blind randomized controlled trial and was conducted at the Izmir Probation Directorate in Turkey between June and November 2023. A total of 115 participants were recruited and randomly assigned to an intervention group (n = 58) and a control group (n = 57). The intervention group received a structured program consisting of six bi-weekly sessions based on motivational interviewing and cognitive-behavioral strategies. No intervention program was administered to the control group. Standardized self-report tools, including the Alcohol Use Disorders Identification Test (AUDIT), the Michigan Alcoholism Screening Test (MAST), and the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES), were administered as pre- and post-tests. Statistical analysis included paired-samples t-tests, independent-samples t-tests, ANOVA, chi-square, and regression analysis. The results showed that participants in the intervention group demonstrated a significant reduction in alcohol use and related problems, as well as a significant increase in motivation to change, compared to the control group. The study demonstrates that the AIP is effective in supporting rehabilitation within the probation system and highlights the need for structured, alcohol-specific programs in this context. This research is significant in that it represents the first intervention program developed specifically for alcohol use within the probation system in Turkey. The findings suggest that the program can be integrated into existing probation practices and adapted to other contexts with similar needs. This study helps fill an important gap in the system and provides a foundation for future large-scale implementation research.
- Being tested
- Alcohol Intervention Program (AIP)
- Keywords
- Alcohol Use, Alcohol Intervention, Criminal Justice System, Probation, Psychosocial Intervention, Randomized Controlled Trial
- Medical subject headings
- Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol Intervention Program (AIP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
This secondary outcome assessed changes in alcohol-related problems using the Michigan Alcoholism Screening Test (MAST). The MAST consists of 25 items with a total score range of 0 to 53. Higher scores indicate alcohol-related problems and impairments in social functioning. Scores at baseline and at the end of the study (Week 12) were compared, and reductions indicated improvements in alcohol-related problems.
Measured: From baseline to study completion (Week 12, immediately after completion of the 6-session program)
Increase in Motivation to Change (SOCRATES Score)
This outcome measured participants' motivation to change their alcohol use behaviors using the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES). The version used in this study included 19 items with a total score range of 19 to 95. Higher scores indicated greater readiness for change and stronger motivation to reduce alcohol use. Scores at baseline and at the end of the study (Week 12) were compared, and an increase in scores reflected a rise in participants' motivation to change.
Measured: From baseline to study completion (Week 12, immediately after completion of the 6-session program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start1 Jun 2023
- Primary completion1 Nov 2023
- Study completion11 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to either the intervention or the control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mine Pazarcikci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mine Pazarcikci, Ege University
- Investigators
- Mine Pazarcıkcı, PhD, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966180
- Sponsor's protocol ID
- RCT-AIP-2025
- Other IDs
- 22-10.1T/32
- Acronym
- PROB-AIP
- Status last verified
- May 2025
- First submitted
- 3 May 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of the Effectiveness of an Alcohol Intervention Program for Adults on Probation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06966180
- Acronym / sponsor ID
- PROB-AIP / RCT-AIP-2025
- Keywords
- Alcohol Use, Alcohol Intervention, Criminal Justice System, Probation, Psychosocial Intervention, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Mine PazarcikciUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 11 May 2024 (actual)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aimed to develop and evaluate the effectiveness of a structured Alcohol Intervention Program (AIP) for adults under probation who experience alcohol-related problems. The research was designed as a single-blind randomized controlled trial and was conducted at the Izmir Probation Directorate in Turkey between June and November 2023. A total of 115 participants were recruited and randomly assigned to an intervention group (n = 58) and a control group (n = 57). The intervention group received a structured program consisting of six bi-weekly sessions based on motivational interviewing and cognitive-behavioral strategies. No intervention program was administered to the control group. Standardized self-report tools, including the Alcohol Use Disorders Identification Test (AUDIT), the Michigan Alcoholism Screening Test (MAST), and the Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES), were administered as pre- and post-tests. Statistical analysis included paired-samples t-tests, independent-samples t-tests, ANOVA, chi-square, and regression analysis. The results showed that participants in the intervention group demonstrated a significant reduction in alcohol use and related problems, as well as a significant increase in motivation to change, compared to the control group. The study demonstrates that the AIP is effective in supporting rehabilitation within the probation system and highlights the need for structured, alcohol-specific programs in this context. This research is significant in that it represents the first intervention program developed specifically for alcohol use within the probation system in Turkey. The findings suggest that the program can be integrated into existing probation practices and adapted to other contexts with similar needs. This study helps fill an important gap in the system and provides a foundation for future large-scale implementation research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to either the intervention or the control group.
| Arm | Type | Receives |
|---|---|---|
| Alcohol Intervention Program (AIP) | Experimental | Behavioral: Alcohol Intervention Program (AIP)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol Intervention Program (AIP)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. | Behavioural | Alcohol Intervention Program (AIP) |
Primary outcome
Reduction in Alcohol Use (AUDIT Score)
Time frame: From baseline to study completion (Week 12, immediately after completion of the 6-session program)
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.
2 secondary outcomes
Reduction in Alcohol-Related Problems (MAST Score)
Time frame: From baseline to study completion (Week 12, immediately after completion of the 6-session program)
Increase in Motivation to Change (SOCRATES Score)
Time frame: From baseline to study completion (Week 12, immediately after completion of the 6-session program)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mine Pazarcıkcı, PhD principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol Intervention Program (AIP) in people with Alcohol Use Disorder and Problem Drinking, run by Mine Pazarcikci at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Alcohol Use (AUDIT Score) (time frame: From baseline to study completion (Week 12, immediately after completion of the 6-session program)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.