Risk Behaviors in Adolescents With Chronic Diseases | NCT05793411

Studies
Risk Behaviors in Adolescents With Chronic Diseases

NCT05793411

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Mar 31, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Chronic Disease
Somatic Disorders

Interventions

Questionnaire risk behaviors in adolescents with chronic diseases

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

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Jul 1, 2023Estimated

Completion Date

Dec 1, 2023Estimated

First Submitted Date

Mar 20, 2023

First Submission Date that Met QC Criteria

Mar 20, 2023

First Posted Date

Mar 31, 2023Actual

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

Mar 20, 2023

Last Update Posted Date

Mar 31, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Little is known about the prevalence of risk behaviors (RBs), in adolescents living with a chronic condition (CC) Objectives Main objective: To characterize the engagement of adolescents with somatic CC recognized as ALD (SCC-ALD) into RBs, compared to the French GP Secondary objectives

To identify factors associated with RBs in adolescents with somatic CC-ALD
To elicit strategies of preventive action of RBs in adolescents with somatic CC-ALD Methods multicenter, cross-sectional survey , based on a mixed qualitative-quantitative approach with an explanatory sequential design (2 consecutive steps): STEP 1 : QUANTITATIVE COMPONENT
- N expected =500
- Inclusion criteria : 14 to 18 years, With a SCC-ALD,Without cognitive impairment and/or psychiatric disease
- Pseudonymised self-administered paper questionnaire (50 items) completed by eligible adolescents during a visit at referring hospital
- statistical analysis : Comparative to the French GP: matching with two datasets (Enclass-HBSC 2022 and Portraits d'Adolescents 2013 surveys); identification of risk factors and risk subgroups STEP 2 : QUALITATIVE COMPONENT: Focus groups of adolescents with somatic CC-ALD (5 focus groups of 6-8 adolescents, conducted by a researcher in SHS) Perspectives

CARMAC will :

Provide a better understanding of RBs in adolescents with severe somatic CC and
Help develop strategies to prevent RBs to enhance the strategies of reducing the addictions to psychoactive substances and health inequalities in this population
Serve as a methodological model for future studies

Detailed Description

To identify factors associated with RBs in adolescents with somatic CC-ALD
To elicit strategies of preventive action of RBs in adolescents with somatic CC-ALD Methods multicenter, cross-sectional survey , based on a mixed qualitative-quantitative approach with an explanatory sequential design (2 consecutive steps) STEP 1 : QUANTITATIVE COMPONENT
- N expected =500
- Inclusion criteria : 14 to 18 years, With a SCC-ALD,Without cognitive impairment and/or psychiatric disease
- Pseudonymised self-administered paper questionnaire (50 items) completed by eligible adolescents during a visit at referring hospital
- statistical analysis : Comparative to the French GP: matching with two datasets (Enclass-HBSC 2022 and Portraits d'Adolescents 2013 surveys); identification of risk factors and risk subgroups STEP 2 : QUALITATIVE COMPONENT: Focus groups of adolescents with somatic CC-ALD (5 focus groups of 6-8 adolescents, conducted by a researcher in SHS) Perspectives

CARMAC will :

Provide a better understanding of RBs in adolescents with severe somatic CC and
Help develop strategies to prevent RBs to enhance the strategies of reducing the addictions to psychoactive substances and health inequalities in this population
Serve as a methodological model for future studies

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

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire risk behaviors in adolescents with chronic diseases	Other	Questionnaire risk behaviors in adolescents with chronic diseases

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of risky behaviors in adolescents with somatic chronic conditions recognized as ALD (SCC-ALD) compared to the French General Population	prevalence of tobacco, cannabis and alcohol us, of risky sexuality, of dangerous games	6 months

Secondary Outcomes

Measure	Description	Time Frame
Factors associated with high prevalence of risky behaviors in of adolescents with somatic chronic conditions recognized as ALD (SCC-ALD) compared to the French General Population	gender, age, social background, self-esteem, type of chronic condition, perceived burden of chronic condition (pain, treatment, social impact)	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

14 to 18 years, living with a somatic chronic condition, recognized as an ALD (long duration disease)

Exclusion Criteria:

cognitive impairment and/or psychiatric disease

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Adolescents living with a severe chronic condition

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Helene MELLERIO, MD	Contact	+331 40 03 41 32		helene.mellerio@aphp.fr
Paul JACQUIN, MD PhD	Contact	+331 40 03 41 32		paul.jacquin@aphp.fr

Overall Officials

Name	Affiliation	Role
Helene MELLERIO, MD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Robert Debre Hospital	Recruiting	Paris		75019	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002908	Chronic Disease

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided