Clinical trial NCT05793411: Risk Behaviors in Adolescents With Chronic Diseases
Official title: Risk Behaviors in Adolescents With Chronic Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Disease
Somatic Disorders
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 500
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents living with a severe chronic condition

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: 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

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

Primary outcomes:
measure: Prevalence of risky behaviors in adolescents with somatic chronic conditions recognized as ALD (SCC-ALD) compared to the French General Population
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debre Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Helene MELLERIO, MD
role: PRINCIPAL_INVESTIGATOR
References: