Risk Behaviors in Adolescents With Chronic Diseases (Carmac)

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Disease; Somatic Disorders
• Intervention / Treatment: Other: Questionnaire risk behaviors in adolescents with chronic diseases

Detailed Description

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

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Helene MELLERIO, MD; Phone Number: +331 40 03 41 32; Email: helene.mellerio@aphp.fr
• Study Contact Backup: Name: Paul JACQUIN, MD PhD; Phone Number: +331 40 03 41 32; Email: paul.jacquin@aphp.fr

Study Locations

• France
  • Paris, France, 75019
    • Recruiting
    • Robert Debre Hospital
    • Contact: Helene MELLERIO, MD; Phone Number: +331 40 03 41 32; Email: helene.mellerio@aphp.fr
    • Contact: Paul JACQUIN, MD PhD; Phone Number: +331 40 03 41 32; Email: paul.jacquin@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adolescents living with a severe chronic condition

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: APHP210802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No