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Social SkillsSkills-PAVIPNCT07145528

Social Skills in Chronic Pain, Addiction, Intimate Partner Violence and Primary Care

An observational study of Social Skills and Primary Care, run by University Hospital, Clermont-Ferrand at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Context: psychosocial competencies (CPS) are higher cognitive functions defined by the ability to interact with others by adopting appropriate and positive behavior. They are defined among three axes: emotional skills, cognitive skills and social skills. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Social Skills, Primary Care
What is being tested?
Questionary with a case-report-form
How many people
600 participants
Where
1 siteFrance
Study dates
1 Sep 2025to 1 Sep 2026
Phase
Observational
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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: All eligible patients attending participating primary care centers during the study period All eligible patients consulting in the pain center of Clermont-Ferrand and Lyon, at the addiction center of Grenoble and Clermont-Ferrand, at the center for the care of perpetrators and victims of violence in Clermont-Ferrand during the study period

Who may be able to join

  • Patients aged 18 and over Suicidal: Patients at risk of suicide, or Suicidal : Patients who have attempted suicide, or Primary care patients

Who cannot join

  • Patients not fluent in French, Patients with an unstabilized psychiatric disorder, Patients refusing to participate in the study. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme, Pregnant and breast-feeding women

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
  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63000

    Lise LACLAUTRE, +334.73.751.195, drci@chu-clermontferrand.fr

    Catherine LAPORTE

Other trials in France

About this study

Official title: Social Skills in Adult Patients Followed for Chronic Pain, Addiction, Intimate Partner Violence or Followed in Primary Care: A Comparative Observational Study

Context: psychosocial competencies (CPS) are higher cognitive functions defined by the ability to interact with others by adopting appropriate and positive behavior. They are defined among three axes: emotional skills, cognitive skills and social skills. Dysfunctions in social skills in adults are linked to substance use and abuse, sensitivity to pain, control of violence, and being a victim of violence. The links are bidirectional: both causes and consequences.

Objectives: Compare the level of psychosocial skills in patients presenting with a use disorder or chronic pain or being victims or perpetrators of domestic violence or patients followed in a primary care center without any of these histories, using the score obtained after passing a scale currently being validated in an adult population.

Read more

Secondary objectives Describe profiles of social skills dysfunction within each population Evaluate the link between alterations in CPS in the different populations and different sociodemographic, intrinsic or environmental criteria

Type of study: multicenter comparative cross-sectional study

Number of centers: twelve (6 multi-professional primary care health centers - 6 hospital centers)

Study description: Cross-sectional, multicenter study. The patients will be included consecutively over a one-year period at the time of their visit to the inclusion center.

Primary endpoint: score obtained for each of the 4 axes on the ad hoc psychosocial skills assessment test.

Number of subjects: 600 patients (60 in each group)

Inclusion criteria

  • Patients aged 18 and over,
  • Patients with chronic pain lasting at least 6 months,
  • Patients with alcohol dependence,
  • Patients victims of intra-family violence,
  • Patients who commit intra-family violence,
  • Patients followed in primary care and not presenting any of the 4 previous items,

Study procedure: each participant, regardless of population, will receive a single 45-minute interview consisting of a validated psychosocial skills assessment test, and a record of consumption status and medico-socio-economic history.

Data will be collected directly online, and the main analysis will be based on a comparative analysis of the level of social skills between the different groups for each of the four axes of the social skills assessment test.

Read the detailed description

Context: psychosocial competencies (CPS) are higher cognitive functions defined by the ability to interact with others by adopting appropriate and positive behavior. They are defined among three axes: emotional skills, cognitive skills and social skills.

Social skills provide the conditions for modulating and controlling emotions, improving individual and social skills, making appropriate decisions, and resisting social conflicts. Poor social skills are linked to psychological disorders and psychiatric disorders such as mood disorders. Dysfunctions in social skills in adults are linked to substance use and abuse, sensitivity to pain, control of violence, and being a victim of violence. The links are bidirectional: both causes and consequences.

I

Objectives:

Main objective Compare the level of psychosocial skills in patients presenting with a use disorder or chronic pain or being victims or perpetrators of domestic violence or patients followed in a primary care center without any of these histories, using the score obtained after passing a scale currently being validated in an adult population,

Secondary objectives Describe profiles of social skills dysfunction within each population Evaluate the link between alterations in CPS in the different populations and different sociodemographic (gender, age, geographical area), intrinsic (executive functions) or environmental criteria (childhood trauma, precariousness...).

Type of study: multicenter comparative cross-sectional study

Number of centers: twelve (6 multi-professional primary care health centers - 6 hospital centers)

Study description: This is a cross-sectional, multicenter study in the RIPH 2 category. The patients will be included consecutively over a one-year period at the time of their visit to the emergency department. This is an interventional study in that a questionnaire will be administered, asking questions about sensitive data. There will be no follow-up.

Primary endpoint: score obtained for each of the four axes on the ad hoc psychosocial skills assessment test.

Number of subjects: 600 patients (60 in each group)

Inclusion criteria

  • Patients aged 18 and over,
  • Patients with chronic pain lasting at least 6 months,
  • Patients with alcohol dependence,
  • Patients victims of intra-family violence,
  • Patients who commit intra-family violence,
  • Patients followed in primary care and not presenting any of the 4 previous items,

Non inclusion criteria Patients not fluent in French, Patients with an unstabilized psychiatric disorder, Patients refusing to participate in the study. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme, Subjects participating in another interventional research study with an exclusion period still in progress at the time of inclusion.

Patients deprived of liberty, under guardianship, curators or safeguard of justice.

Pregnant and breast-feeding women

Study procedure: each participant, regardless of population, will receive a single 45-minute interview consisting of a validated psychosocial skills assessment test, and a record of consumption status and medico-socio-economic history.

Data will be collected directly online, and the main analysis will be based on a comparative analysis of the level of social skills between the different groups for each of the four axes of the social skills assessment test.

Being tested
Questionary with a case-report-form
Keywords
intimate partner violence, addiction, chronic pain
Medical subject headings
Social Skills, Behavior, Addictive, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Questionary with a case-report-formOther

    Questionary with : Gender, Age, Marital Status, medical history, Socio-économic description, skills assessment test written by R-Shankland, AUDIT-C, fargestrom, HAD, CAST, EPICE, Stroop-Test, Trail making test, Rosenberg Test

Study groups in NCT07145528
Study groupRoleWhat they receive
Patients in Primary CareA single E-case report form (CRF) for every group (a 45 minutes interview)
Receives: Other: Questionary with a case-report-form
Patients with chronic painA single E-case report form (CRF) for every group (a 45 minutes interview)
Receives: Other: Questionary with a case-report-form
Patients victims of violenceA single E-case report form (CRF) for every group (a 45 minutes interview)
Receives: Other: Questionary with a case-report-form
Patients perpetrators of violenceA single E-case report form (CRF) for every group (a 45 minutes interview)
Receives: Other: Questionary with a case-report-form
Patients with alcohol dependenceA single E-case report form (CRF) for every group (a 45 minutes interview)
Receives: Other: Questionary with a case-report-form

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Score of psychosocial skills

    15-item scale, grouped into 4 axes: emotional (5 items), cognitive (4 items), social (4 items), assertiveness (2 items). The response modality is a Likert scale with 7 possible answers ranging from "Never" (1) to "Always" (7). The alpha-cronbach coefficient was 0.754 for the cognitive axis, 0.731 for the social axis and 0.654 for the emotional axis

    Measured: 5 minutes

Secondary outcomes (1)
  1. Results of the others test

    Sociodemographics criterias, intrinsics criteria, medical history, patient's health

    Measured: 45 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07145528
Sponsor's protocol ID
CHU Clermont-Ferrand
Other IDs
2024-A00933-44
Acronym
Skills-PAVIP
Status last verified
Jul 2025
First submitted
19 Feb 2025
Last updated
28 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Social Skills and Primary Care, run by University Hospital, Clermont-Ferrand 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 28 Aug 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 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 Lise Laclautre (+334.73.751.195, drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score of psychosocial skills (time frame: 5 minutes). 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 28 Aug 2025.

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