NCT02862626

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 11, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

12 months

First QC Date

August 8, 2016

Last Update Submit

October 12, 2017

Conditions

Depression

Keywords

Diabetic childrenMothers

Outcome Measures

Primary Outcomes (1)

  • Evaluation of depression among mothers of children aged 5 or under with type 1 diabetes

    Assessment with self-administered questionnaires

    at enrollment

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mothers of diabetic children aged 5 and under followed-up in Pediatrics Department of Besançon University Hospital.

You may qualify if:

  • Mother of diabetic child aged 5 and under, followed-up in Pediatrics Department of Besançon University Hospital.

You may not qualify if:

  • Mother of diabetic child older than 5 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Brigitte Mignot, MD

    CHU Besançon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2016

First Posted

August 11, 2016

Study Start

January 11, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

October 13, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)