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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05793411
Other study ID # APHP210802
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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