NCT02884570

Brief Summary

To assess the prevalence of anxiety / depression in post- hospital for parents (mothers and fathers) of children with tracheotomy before the age of 1 year between 2000 and 2012.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 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

April 1, 2014

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2019

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

3.3 years

First QC Date

August 4, 2016

Last Update Submit

May 27, 2024

Conditions

Tracheotomised ChildrenAnxiety of ParentsDepression of Parents

Keywords

TracheotomyAnxietyDepressionBack Home

Outcome Measures

Primary Outcomes (1)

  • Anxiety and Depression

    Auto-questionnaire Hospital Anxiety and Depression Scale HADS

    Through study completion, up to 6 months

Secondary Outcomes (1)

  • Experienced of the care by the families

    Through study completion, up to 6 months

Interventions

Auto-QuestionnairesOTHER

Consents and questionnaires will be sent to the parental home or filled in an interview with an investigator (or telephone consultation).

Eligibility Criteria

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

Parents (mothers and fathers) of children with tracheotomy before the age of 1 year between 2000 and 2012. Pre- selection will take place in Pediatric Neonatal and Reanimation services of Montpellier, Paris (Hôpital Robert Debré ) and Strasbourg

You may qualify if:

  • Families whose child :
  • Has been tracheotomised before the age of 1 year between 2000 and 2012
  • Came out of hospital with a tracheotomy tube
  • Is or has been followed by one of three centers

You may not qualify if:

  • Children decannulated before hospital discharge .
  • Death before the start of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Gilles Cambonie, Professor

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 31, 2016

Study Start

April 1, 2014

Primary Completion

July 1, 2017

Study Completion

July 17, 2019

Last Updated

May 29, 2024

Record last verified: 2024-05

Locations

FR(1)