Parental Mental Health After Tracheostomy in Early Childhood | NCT02884570

Studies
Parental Mental Health After Tracheostomy in Early Childhood

NCT02884570

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

May 29, 2024Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Tracheotomised Children
Anxiety of Parents
Depression of Parents

Interventions

Auto-Questionnaires

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014Actual

Primary Completion Date

Jul 2017Actual

Completion Date

Jul 17, 2019Actual

First Submitted Date

Aug 4, 2016

First Submission Date that Met QC Criteria

Aug 25, 2016

First Posted Date

Aug 31, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2024

Last Update Posted Date

May 29, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The goal of this study is to evaluate the level of anxiety / depression of families and to correlate to the lived parental of tracheotomy and indirectly that of the child (hetero - evaluation).

The information from this study should allow staff to refine and adjust their practices in terms of information and support for families with tracheotomised children. The information given to families before the establishment of a tracheotomy for their child may also be adapted.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Auto-Questionnaires	Other	Consents and questionnaires will be sent to the parental home or filled in an interview with an investigator (or telephone consultation).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anxiety and Depression	Auto-questionnaire Hospital Anxiety and Depression Scale HADS	Through study completion, up to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Experienced of the care by the families	Auto-questionnaire Hartnick	Through study completion, up to 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria :

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

Exclusion criteria :

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gilles Cambonie, Professor	University Hospital, Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Montpellier		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001008	Anxiety Disorders
D003863	Depression

Ancestor Terms

ID	Term
D001523	Mental Disorders
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided