NCT05490589

Brief Summary

Alcohol use disorders are a major public health problem in Europe. The average prevalence of Alcohol Use Disorders (AUD) in the general population is 7.5%, although there are large variations between countries. According to the literature, 20 to 30% of children have parents with problematic alcohol use. Public health authorities are alarmed by the precociousness of alcohol consumption in the youngest age and by the prevalence of alcohol consumption in adolescence. One of the well-established risk factors for alcohol use and abuse is having a parent with AUD. Compared with people growing up without any parent with AUD, the relative risk of suffering negative life events in childhood is 2 to 13 times higher if one or both parents have alcohol use disorders. A family history of Alcohol Use Disorders is predictive of earlier alcohol, tobacco, or cannabis use in adolescence, but it is also associated with a higher risk of developing substance use disorders.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Feb 2024Aug 2027

First Submitted

Initial submission to the registry

August 4, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2022

Completed
1.6 years until next milestone

Study Start

First participant enrolled

February 22, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2026

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2027

Expected
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

August 4, 2022

Last Update Submit

December 16, 2025

Conditions

Keywords

Alcohol dependance

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of a parenting program

    Overall score measuring the level of parental stress, obtained using the Parental Stress Index (PSI), measured at the post-inclusion visit and at the 6-month post-program visit. Parental Stress Index was designed to evaluate the magnitude of stress in the parent-child system, with 101-item inventory that focuses on two major domains of stress: child characteristics and parent characteristics. The score is obtained by summing the responses to the items and then converting it to a percentile. A high score means that the parent is stressed.

    At 6 month post EQUIPE program

Secondary Outcomes (8)

  • Score on the different domains of the Parental Stress Index

    At 6 month post EQUIPE program

  • Evaluation of self-esteem

    At 3, 6 and 12 month post EQUIPE program

  • Evaluation on children's behaviors

    At 3, 6 and 12 month post EQUIPE program

  • Evaluation of alcohol use

    At 3, 6 and 12 month post EQUIPE program

  • Evaluation of severity of alcohol use disorders

    At 3, 6 and 12 month post EQUIPE program

  • +3 more secondary outcomes

Study Arms (1)

EQUIPE Program

EXPERIMENTAL
Other: EQUIPE Program

Interventions

EQUIPE is a manualised group community-based parent education programme. Groups consist of 15 parents who meet with one or two trained group leaders for weekly 2-hour sessions over 10 weeks. This program promotes skill development in parents, strengthens relationships with children, increases cooperation, and helps solve problems in the home.

EQUIPE Program

Eligibility Criteria

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

You may qualify if:

  • Major subject (age \> 18 years)
  • Patient with a child between 4 and 12 years old
  • Patient living with his/her child permanently or partially
  • Patient or his/ her spouse with an alcohol use disorder (at least 3 of the 11 DSM 5 criteria for alcohol use disorder in the past 12 months)
  • Written and informed consent

You may not qualify if:

  • Minor subject (age \< 18 years)
  • Acute, unstabilized psychiatric disorder impairing judgment
  • Incapacity or refusal to give consent
  • Subject under judicial protection or family habilitation
  • Subject deprived of liberty by judicial or administrative decision, under guardianship or curatorship ;
  • Non comprehension of the French language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Brest

Brest, 29609, France

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Morgane GUILLOU - LANDREAT, Dr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2022

First Posted

August 5, 2022

Study Start

February 22, 2024

Primary Completion

February 22, 2026

Study Completion (Estimated)

August 22, 2027

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning 42 month and ending 15 years following the final study report completion.
Access Criteria
Data access requests will be reviewed by the internal committee of BrestUH. Requestors will be required to sign and complete a data access agreement.

Locations