Risk Behaviors in Adolescents With Chronic Diseases

Chronic Disease Clinical Trial

— Carmac  

Official title:

Risk Behaviors in Adolescents With Chronic Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05793411
• Other study ID #: APHP210802
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: March 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Helene MELLERIO, MD
• Phone: +331 40 03 41 32
• Email: helene.mellerio[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 1, 2023
• Est. primary completion date: July 1, 2023
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Somatic Disorders

Intervention

Other:
• Questionnaire risk behaviors in adolescents with chronic diseases
Questionnaire risk behaviors in adolescents with chronic diseases

Locations

Country	Name	City	State
France	Robert Debre Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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