Risk Behaviors in Adolescents With Chronic Diseases
Carmac
1 other identifier
observational
500
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedFirst Submitted
Initial submission to the registry
March 20, 2023
CompletedFirst Posted
Study publicly available on registry
March 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedMarch 31, 2023
March 1, 2023
6 months
March 20, 2023
March 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Interventions
Questionnaire risk behaviors in adolescents with chronic diseases
Eligibility Criteria
Adolescents living with a severe chronic condition
You may qualify if:
- to 18 years, living with a somatic chronic condition, recognized as an ALD (long duration disease)
You may not qualify if:
- cognitive impairment and/or psychiatric disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Robert Debre Hospital
Paris, 75019, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helene MELLERIO, MD
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2023
First Posted
March 31, 2023
Study Start
January 1, 2023
Primary Completion
July 1, 2023
Study Completion
December 1, 2023
Last Updated
March 31, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share