Carmac: Risk Behaviors in Adolescents With Chronic Diseases

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT05793411

Collaborator

(none)

500

Enrollment

Location

Anticipated Duration (Months)

45.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Disease Somatic Disorders	Other: Questionnaire risk behaviors in adolescents with chronic diseases

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Risk Behaviors in Adolescents With Chronic Diseases

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 [6 months]
gender, age, social background, self-esteem, type of chronic condition, perceived burden of chronic condition (pain, treatment, social impact)

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 18 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Robert Debre Hospital	Paris		France	75019

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Helene MELLERIO, MD, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT05793411

Other Study ID Numbers:

APHP210802

First Posted:

Mar 31, 2023

Last Update Posted:

Mar 31, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Chronic Disease

Study Results

No Results Posted as of Mar 31, 2023