DepressionPSY-DIA-MUMNCT02862626
Assessment of Psychological State of Mothers of Diabetic Children Aged 5 and Under (in Terms of Depression, Stress, Coping , Anxiety, Fear of Hypoglycemia) and Influencing Factors of This Psychological State
An observational study of Depression, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The incidence of type one diabetes is still rising, especially in children under 5 years old. Mothers often are the primary caregivers of these children. To take care of a young child with diabetes is a great responsibility and mothers must be constantly vigilant. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Depression
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2016to Jan 2017
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Mothers of diabetic children aged 5 and under followed-up in Pediatrics Department of Besançon University Hospital.
Who may be able to join
- Mother of diabetic child aged 5 and under, followed-up in Pediatrics Department of Besançon University Hospital.
Who cannot join
- Mother of diabetic child older than 5 years old
Trial locations and contacts
1 site in 1 country.
About this study
The incidence of type one diabetes is still rising, especially in children under 5 years old. Mothers often are the primary caregivers of these children. To take care of a young child with diabetes is a great responsibility and mothers must be constantly vigilant. This study aims to assess the psychological state of these mothers (in term of depression, anxiety, stress, coping, fear of hypoglycemia) and factors which influence this state.
- Conditions
- Depression
- Keywords
- Diabetic children, Mothers
- Medical subject headings
- Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of depression among mothers of children aged 5 or under with type 1 diabetes
Assessment with self-administered questionnaires
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start11 Jan 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Family based
- Time perspective
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brigitte Mignot, MD, Principal investigator, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862626
- Sponsor's protocol ID
- P/2015/282
- Acronym
- PSY-DIA-MUM
- Status last verified
- Oct 2017
- First submitted
- 8 Aug 2016
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Psychological State of Mothers of Diabetic Children Aged 5 and Under (in Terms of Depression, Stress, Coping , Anxiety, Fear of Hypoglycemia) and Influencing Factors of This Psychological State
- ClinicalTrials.gov ID
- NCT02862626
- Acronym / sponsor ID
- PSY-DIA-MUM / P/2015/282
- Conditions
- Depression
- Keywords
- Diabetic children, Mothers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 11 Jan 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 11 Aug 2016 (estimated)
- 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 incidence of type one diabetes is still rising, especially in children under 5 years old. Mothers often are the primary caregivers of these children. To take care of a young child with diabetes is a great responsibility and mothers must be constantly vigilant. This study aims to assess the psychological state of these mothers (in term of depression, anxiety, stress, coping, fear of hypoglycemia) and factors which influence this state.
Study design
- Observational model
- Family based
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mothers of diabetic children aged 5 and under followed-up in Pediatrics Department of Besançon University Hospital.
Key inclusion criteria (1 listed)
- Mother of diabetic child aged 5 and under, followed-up in Pediatrics Department of Besançon University Hospital.
Key exclusion criteria (1 listed)
- Mother of diabetic child older than 5 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of depression among mothers of children aged 5 or under with type 1 diabetes
Time frame: at enrollment
Assessment with self-administered questionnaires
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 Oct 2017.
- 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.
Brigitte Mignot, MD principal investigator
CHU Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Centre Hospitalier Universitaire de Besancon 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: finished, as of the sponsor's last update on 13 Oct 2017. 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?
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?
Evaluation of depression among mothers of children aged 5 or under with type 1 diabetes (time frame: at enrollment). 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 Oct 2017.