Addiction, AlcoholAPPROCHILDNCT05490589
Evaluation of the Implementation of a Parenting Program in Parents With Children Aged 4 to 12 Years and One Parent With an Alcohol Use Disorders
A study testing EQUIPE Program in people with Addiction, Alcohol, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Addiction, Alcohol
- What is being tested?
- EQUIPE Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2024to 22 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Brest
Brest, 29609
Morgane GUILLOU, morgane.guillou@chu-brest.fr
About this study
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.
Read the detailed description
Despite these alarming data, very few studies have focused on preventing alcohol use in vulnerable populations with at least one parent with Alcohol Use Disorders. Parenting support programs have been developed, according to current knowledges, there are no programs in French that target families with Alcohol Use Disorders.
The EQUIPE program is a French adaptation of the Canadian program, Community Parent Education (COPE). It is a psycho-educational intervention program developed́ by C. Cunningham (McMaster University, Hamilton, ON). It is aimed at improving parenting skills. Its format involves a 2 hr/week session and is spread over 10 weeks. During the sessions, using short video vignettes, parents are encouraged to find their own solutions to difficulties in managing their child's behaviour. These solutions are then discussed among parents in the presence of professionals (animators or facilitators). Finally, educational strategies are adopted and practiced in the family setting. This program aims to strengthen the protective factors of children in the face of risky behaviours that they may develop during adolescence, by having parents and children work together on communication, the establishment of warm and positive relationships and their ability to resolve problems and conflicts. This EQUIPE program has been evaluated in Quebec with families experiencing difficulties with children with behavioral problems. At present, in France, no parenting support program is applied to families with addictive behaviors in a broad and evaluated manner. The investigators believe that an "early" intervention could allow to apprehend future social and mental problems (malaise and depression, school dropout, delinquency...), and limit the risks of intra-family conflicts and thus reduce the negative impact on the potential development of psychological disorders and addictive behaviors in adolescence and adulthood. The implementation of this parenting support program, applied to families suffering from alcohol addictive behaviors and at an early stage with children aged 3-12 years, would seem to be relevant in order to reinforce parenting skills.
- Conditions
- Addiction, Alcohol
- Being tested
- EQUIPE Program
- Keywords
- Alcohol dependance
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EQUIPE ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| EQUIPE Program | Experimental | Not described Receives: Other: EQUIPE Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 month post EQUIPE program
Secondary outcomes (8)
Score on the different domains of the Parental Stress Index
The different domains of the Parental Stress Index were :
- Within the Child Domain, six subscales (Distractibility/Hyperactivity, Adaptability, Demandingness, Reinforces Parent, Acceptability and Mood)
- Within the Parent Domain, seven subscales (Competence, Isolation, Attachment, Health, Role Restriction, Depression, and Spouse/Parenting Partner Relationship)
- The Total Stress scale is combined of the two domains (Child and Parent).
Measured: At 6 month post EQUIPE program
Evaluation of self-esteem
Self-esteem is evaluated by the Rosenberg scale. The Rosenberg Self-Esteem Scale measures overall self-confidence by measuring both positive and negative feelings. The scale has 10 items. Each item is measured on a scale of 1 to 4, from strongly disagree for 1 to strongly agree for 4.
Measured: At 3, 6 and 12 month post EQUIPE program
Evaluation on children's behaviors
For assessed the impact on children's behaviors, Strengths and Difficulties Questionnaire (SDQ) was used. SDQ is a questionaire which used for mental health problems screening in children. This questionnaire measures the presence of behaviours that indicate emotional difficulties such as physical aggression, isolation, anxiety, difficulty concentrating and impulsivity. It is intended for children from 3 to 16 years old and can be completed by the parent. SDQ includes 25 questions that the parent can answer with "not true", "somewhat true" or "very true". The score is obtained as follows: for each statement, the answer "false" gives zero points, "somewhat true" one point and "absolutely true" two points. With the exception of the items marked in bold, for which the "false" answer gives two points and the "absolutely true" answer zero, the other option remains the same. Emotional or behavioral difficulties are considered to exist when the score is 16 or higher.
Measured: At 3, 6 and 12 month post EQUIPE program
Evaluation of alcohol use
Alcohol consumption measured by the Alcohol Timeline Followback (ATLFB) score at each visit. The A-TLFB is a method of assessing alcohol consumption that provides an estimate of the daily amount of alcohol consumed in standard units.It has been evaluated in clinical and non-clinical populations and in adults and adolescents. It is in the form of a calendar. Respondents report their daily alcohol consumption over a specified period of the past 30 days. Recall aids can be used during the completion of the questionnaire (dates, events, etc.). This tool has good psychometric qualities and is recommended when precise information on the quantities of alcohol consumed or the number of days of consumption is needed.
It allows to identify the number of days of alcohol consumption in the month and the number of days with alcohol consumption above 5 standard units/d.
No score is obtained but we have the follow-up of the patients' consumption
Measured: At 3, 6 and 12 month post EQUIPE program
Evaluation of severity of alcohol use disorders
Severity of alcohol use disorders at each visit, as measured by the number of Diagnostic and Statistical manual of Mental disorders 5 (DSM5) criteria. The DSM5 score is diagnosis of addiction is based on well-defined criteria set out in the Diagnostic and Statistical manual of Mental disorders (DSM), the fifth edition of which was published in 2013. The questionnaire consists of 11 items (diagnostic criteria for substance use disorders from the American Psychiatric Association's DSM V). The presence of 2 to 3 criteria: low addiction / Presence of 4 to 5 criteria: moderate addiction / Presence of 6 or more criteria: severe addiction.
Measured: At 3, 6 and 12 month post EQUIPE program
Evaluation of the progression of anxiety and depressive symptoms
Evaluation of the progression of anxiety and depressive symptoms This evolution will be assessed by Hopkins Symptom Checklist (HSCL25). The HSCL-25 is a questionnaire, consisting of 25 questions relating to the presence and intensity of symptoms of anxiety (question ranging from 1 to 10) and depression (question ranging from 11 to 25) during the last full week. The patient is asked to rate each item on a four-point scale, ranging from 1: strongly disagree, to 4: strongly agree. To obtain the diagnostic score, the responses to all questions are summed and divided by 25.
Measured: At 3, 6 and 12 month post EQUIPE program
Evaluation of the quality of life during the follow-up time
Quality of life evaluated by the World Health Organization Quality of Life (WHOQOL scale brief). The WHOQOL-BREF instrument consists of 26 items that measure the following broad domains: physical health, psychological health, social relationships and environment. It is used to assess the quality of life of adults.
Each question is scored on a 5-point Likert scale (1 to 5). The sum of the points gives us the score. The higher the score, the better the patient's quality of life
Measured: At 3, 6 and 12 month post EQUIPE program
Evaluation of acceptability of the study by the participants
Acceptability will be assessed using a Likert scale that asks individuals about their level of agreement or disagreement with a statement. The question "Do you think your participation in the EQUIPE program was useful to you?" will be asked at the end of the program.
Free comments will be left open with a question "Do you have any comments on the program?"
Measured: At 3 month post EQUIPE program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start22 Feb 2024
- Primary completion22 Feb 2028 (estimated)
- Study completion22 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Addiction, AlcoholStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490589
- Sponsor's protocol ID
- 29BRC20.0173
- Acronym
- APPROCHILD
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2022
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Implementation of a Parenting Program in Parents With Children Aged 4 to 12 Years and One Parent With an Alcohol Use Disorders
- ClinicalTrials.gov ID
- NCT05490589
- Acronym / sponsor ID
- APPROCHILD / 29BRC20.0173
- Conditions
- Addiction, Alcohol
- Keywords
- Alcohol dependance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 22 Feb 2028 (estimated)
- Study completion
- 22 Aug 2029 (estimated)
- First posted
- 5 Aug 2022 (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.
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.
Detailed description
Despite these alarming data, very few studies have focused on preventing alcohol use in vulnerable populations with at least one parent with Alcohol Use Disorders. Parenting support programs have been developed, according to current knowledges, there are no programs in French that target families with Alcohol Use Disorders.
The EQUIPE program is a French adaptation of the Canadian program, Community Parent Education (COPE). It is a psycho-educational intervention program developed́ by C. Cunningham (McMaster University, Hamilton, ON). It is aimed at improving parenting skills. Its format involves a 2 hr/week session and is spread over 10 weeks. During the sessions, using short video vignettes, parents are encouraged to find their own solutions to difficulties in managing their child's behaviour. These solutions are then discussed among parents in the presence of professionals (animators or facilitators). Finally, educational strategies are adopted and practiced in the family setting. This program aims to strengthen the protective factors of children in the face of risky behaviours that they may develop during adolescence, by having parents and children work together on communication, the establishment of warm and positive relationships and their ability to resolve problems and conflicts. This EQUIPE program has been evaluated in Quebec with families experiencing difficulties with children with behavioral problems. At present, in France, no parenting support program is applied to families with addictive behaviors in a broad and evaluated manner. The investigators believe that an "early" intervention could allow to apprehend future social and mental problems (malaise and depression, school dropout, delinquency...), and limit the risks of intra-family conflicts and thus reduce the negative impact on the potential development of psychological disorders and addictive behaviors in adolescence and adulthood. The implementation of this parenting support program, applied to families suffering from alcohol addictive behaviors and at an early stage with children aged 3-12 years, would seem to be relevant in order to reinforce parenting skills.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EQUIPE Program | Experimental | Other: EQUIPE Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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 ;
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 |
|---|---|---|
| EQUIPE ProgramEQUIPE 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. | Other | EQUIPE Program |
Primary outcome
Effectiveness of a parenting program
Time frame: At 6 month post EQUIPE 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.
8 secondary outcomes
Score on the different domains of the Parental Stress Index
Time frame: At 6 month post EQUIPE program
Evaluation of self-esteem
Time frame: At 3, 6 and 12 month post EQUIPE program
Evaluation on children's behaviors
Time frame: At 3, 6 and 12 month post EQUIPE program
Evaluation of alcohol use
Time frame: At 3, 6 and 12 month post EQUIPE program
Evaluation of severity of alcohol use disorders
Time frame: At 3, 6 and 12 month post EQUIPE program
Evaluation of the progression of anxiety and depressive symptoms
Time frame: At 3, 6 and 12 month post EQUIPE program
Evaluation of the quality of life during the follow-up time
Time frame: At 3, 6 and 12 month post EQUIPE program
Evaluation of acceptability of the study by the participants
Time frame: At 3 month post EQUIPE program
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EQUIPE Program in people with Addiction, Alcohol, run by University Hospital, Brest at 1 site in France.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 1 Oct 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Morgane GUILLOU - LANDREAT, Dr (29822342348 ext. +33, morgane.guillou@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of a parenting program (time frame: At 6 month post EQUIPE 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 1 Oct 2026.