Psychiatric DisorderIGDPDNCT03366948
Internet Gaming Disorder and Psychiatric Disorder
An observational study of Psychiatric Disorder, run by Hospices Civils de Lyon at 5 sites in France.
Trial summary
The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) recently identified Internet gaming disorder as a new potential psychiatric disorder which need further research. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Psychiatric Disorder
- What is being tested?
- IGDT-10 self-administered questionnaire
- How many people
- 102 participants
- Where
- 5 sitesFrance
- Study dates
- 16 Mar 2018to 14 Sep 2018
- Phase
- Observational
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patient aged from 12 to 17 of 4 psychiatric units of French region Auvergne-Rhône-Alpes and their parents.
Who may be able to join
- Patient aged from 12 to 17
- Parents of the patient, older than 18 years old
- Patients hospitalized in 4 psychiatric units of French region Auvergne-Rhône-Alpes
Who cannot join
- Patient and/or theirs parents are not fluent in French
- Intellectual deficit (known intelligence quotient below 70)
- Behaviour disorder making impossible to pass the questionnaire
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Service de pédopsychiatrie Centre hospitalier Pierre Oudot
Bourgoin, 38302
Psychopathologie du Développement Hôpital Femme Mère Enfant
Bron, 69677
Service de psychiatrie adulte Hôpital Pierre Wertheimer-GHE
Bron, 69677
Service de pédopsychiatrie - Unité H.Flavigny Centre hospitaliser Le Vinatier
Bron, 69678
Service de pédopsychiatrie - Unité Adolescents ULYSSE - Centre hospitalier St Jean-de-Dieu
Lyon, 69008
About this study
Official title: Internet Gaming Disorder Prevalence of Teenager Psychiatric Inpatient of 4 Psychiatric Units of French Region Auvergne-Rhône-Alpes
The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) recently identified Internet gaming disorder as a new potential psychiatric disorder which need further research. Several studies showed the important prevalence of psychiatric disorders among patients suffering from internet gaming disorder. Investigators hypothesize that on an other side the prevalence of internet gaming disorder among patients suffering from psychiatric disorders shall be high but it has never been studied yet.
The main goal of this trial is to examine the prevalence of internet gaming disorder using the Internet Gaming Disorder Test-10 (IGDT-10) among inpatient aged from 12 to 17 of 4 psychiatric units of French region Auvergne-Rhône-Alpes.
Read more
Secondary goals will be to assess a parental version of the IGDT-10 (IGDT-10-P) and to compare the two versions.
IGDT-10 will be passed during 6 months to every inpatient and IGDT-10-P to their parents within the 21 first days of the hospitalisation.
- Conditions
- Psychiatric Disorder
- Being tested
- IGDT-10 self-administered questionnaire
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGDT-10 self-administered questionnaireOther
Patients and their parents will answer the French version of the IGDT-10 self-administered questionnaire (IGDT-10-P in the parents 'questionnaire).
The IGDT-10 is a self-administered questionnaire based on DSM-5 internet gaming disorder criteria and the IGDT-10-P is a parental version specially adapted from the IGDT-10 for this study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a IGDT-10 score above 5
The 10-item Internet Gaming Disorder is a 10 dichotomous items self-assessment scale corresponding to the 9 diagnostic criteria of the DSM-5 IGD (the last item is split in two but should only be counted once). In agreement with DSM-5, a diagnosis of IGD is considered positive if 5 criteria are validated. Each criterion is filled by the patient as "never", "sometimes" or "often", a criterion is validated if it is reported to be present "often" in the last 12 months according to DSM-5 guidelines. The Ten-Item Internet Gaming Disorder Test (IGDT-10) by Király et al. was validated in English for a population of 14 to 64 years10 then in French in adults by Laconi et al.29. This is a valid and reliable scale.
Measured: In the first 21 days after the admission in the psychiatric unit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start16 Mar 2018
- Primary completion14 Sep 2018
- Study completion14 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366948
- Sponsor's protocol ID
- 69HCL17_0685
- Acronym
- IGDPD
- Status last verified
- Aug 2019
- First submitted
- 4 Dec 2017
- Last updated
- 13 Aug 2019
- 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 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Gaming Disorder Prevalence of Teenager Psychiatric Inpatient of 4 Psychiatric Units of French Region Auvergne-Rhône-Alpes
- ClinicalTrials.gov ID
- NCT03366948
- Acronym / sponsor ID
- IGDPD / 69HCL17_0685
- Conditions
- Psychiatric Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 8 Dec 2017 (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 fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) recently identified Internet gaming disorder as a new potential psychiatric disorder which need further research. Several studies showed the important prevalence of psychiatric disorders among patients suffering from internet gaming disorder. Investigators hypothesize that on an other side the prevalence of internet gaming disorder among patients suffering from psychiatric disorders shall be high but it has never been studied yet.
The main goal of this trial is to examine the prevalence of internet gaming disorder using the Internet Gaming Disorder Test-10 (IGDT-10) among inpatient aged from 12 to 17 of 4 psychiatric units of French region Auvergne-Rhône-Alpes.
Secondary goals will be to assess a parental version of the IGDT-10 (IGDT-10-P) and to compare the two versions.
IGDT-10 will be passed during 6 months to every inpatient and IGDT-10-P to their parents within the 21 first days of the hospitalisation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patient aged from 12 to 17 of 4 psychiatric units of French region Auvergne-Rhône-Alpes and their parents.
Key inclusion criteria (3 listed)
- Patient aged from 12 to 17
- Parents of the patient, older than 18 years old
- Patients hospitalized in 4 psychiatric units of French region Auvergne-Rhône-Alpes
Key exclusion criteria (3 listed)
- Patient and/or theirs parents are not fluent in French
- Intellectual deficit (known intelligence quotient below 70)
- Behaviour disorder making impossible to pass the questionnaire
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 |
|---|---|---|
| IGDT-10 self-administered questionnairePatients and their parents will answer the French version of the IGDT-10 self-administered questionnaire (IGDT-10-P in the parents 'questionnaire). The IGDT-10 is a self-administered questionnaire based on DSM-5 internet gaming disorder criteria and the IGDT-10-P is a parental version specially adapted from the IGDT-10 for this study. | Other | – |
Primary outcome
Proportion of patients with a IGDT-10 score above 5
Time frame: In the first 21 days after the admission in the psychiatric unit.
The 10-item Internet Gaming Disorder is a 10 dichotomous items self-assessment scale corresponding to the 9 diagnostic criteria of the DSM-5 IGD (the last item is split in two but should only be counted once). In agreement with DSM-5, a diagnosis of IGD is considered positive if 5 criteria are validated. Each criterion is filled by the patient as "never", "sometimes" or "often", a criterion is validated if it is reported to be present "often" in the last 12 months according to DSM-5 guidelines. The Ten-Item Internet Gaming Disorder Test (IGDT-10) by Király et al. was validated in English for a population of 14 to 64 years10 then in French in adults by Laconi et al.29. This is a valid and reliable scale.
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 13 Aug 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Disorder, run by Hospices Civils de Lyon at 5 sites 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 3 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 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
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?
Proportion of patients with a IGDT-10 score above 5 (time frame: In the first 21 days after the admission in the psychiatric unit.). 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 13 Aug 2019.