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Clinical Trials/NCT04333797
NCT04333797CompletedNot Applicable

Multicentre Prospective Cohort Study Assessing Risk and Protective Factors to Develop Psychopathology in Transitional Age Youth

Queen Fabiola Children's University Hospital8 sites in 1 country252 target enrollmentStarted: June 10, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
252
Locations
8
Primary Endpoint
Change from Baseline self-rated measure of quality of life at 2 years

Study Overview

Brief Summary

This clinical study evaluates risk and protective factor to develop psychopathology in transitional age youth. 300 patients will be recruited at the age of 17 years old and assessed at baseline and 2 years later.

Detailed Description

Emerging adults are a particularly at-risk population in mental health. Transitional age youth have specific needs, not currently covered between child and adolescent mental health services (CAMHS) and adult mental health services (AMHS), mainly because of existing barriers. Movements from one to the other must be planned to achieve optimal patient care.

Our project aims to identify clinical dimensional characteristics contributing to the development of psychopathology during the transition period. Continuities, discontinuities and resilience factors will be explored. The final purpose is to develop a non-stigmatizing approach to reduce rejection from youths in psychopathological suffering and increase social inclusion.

The transversal and trans-diagnostic approach consists of a dimensional evaluation: 300 youth at the age of 17 will be included in a cohort of in-patients, out-patients and control group. Participants will be assessed at baseline and 2 years later. The primary outcome is based on Health of the Nation Outcome Scale for Children and Adolescents, measuring mental health care need, and WHO Quality of Life assessment.

The secondary outcomes include the assessment of dimensions representing risk or protective factors to develop psychopathology and evolution of mental health status during transition age. Baseline evaluation consists in internalizing/externalizing symptoms, impulsivity/compulsivity, emotion regulation, cognitive functioning, social and family functioning, developmental, medical and trauma history. At follow-up, mental health pathways and transition results will be described.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
17 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • French-speaking and French-understanding
  • Subjects who accepted to participated to the study (signature of informed consent/assent document from subjects and parents or legal holder of parental authority)
  • Specific criteria for patients: inpatients and out-patients
  • Specific criteria for control group: youth from general population or placed in residential centres

Exclusion Criteria

  • Impossibility to answer to the assessment tools
  • Medium intellectual disability (homogenous IQ < 75)
  • Presence of a grave somatic disease (cancer, cardiac failure, renal failure, central nervous system disorder), that is progressive or that affects the vital prognosis in the short term
  • Active participation to another study

Outcomes

Primary Outcomes

Change from Baseline self-rated measure of quality of life at 2 years

Time Frame: Change from Baseline WHO-QoL before transition at 17 y.o. to after transition at 19 y.o

Measured at baseline (T0) and follow-up (T1) with the Quality of life assessed by World Health Organisation Quality of Life Assessment (WHO-QoL-BREF)

Change from Baseline self-rated mental health status (need for care) at 2 years

Time Frame: Change from Baseline HoNOSCA before transition at 17 y.o. to after transition at 19 y.o.

Measured at baseline (T0) and follow-up (T1) with the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA).

Secondary Outcomes

  • Self-rated measure of interpersonal relationships social adaptation(Before transition at 17 y.o. (T0))
  • Self-rated measure of cognitive insight(Before transition at 17 y.o. (T0))
  • Executive functions assessment - alertness, divided attention, flexibility and working memory(Before transition at 17 y.o. (T0))
  • Executive functions assessment - cognitive inhibition(Before transition at 17 y.o. (T0))
  • Self-rated measure of traumatic life events(Before transition at 17 y.o. (T0))
  • Self-rated measure of family functioning(Before transition at 17 y.o. (T0))
  • Self-rated measure of internalising and externalising symptoms(Before transition at 17 y.o. (T0))
  • Self-rated measure of emotional regulation(Before transition at 17 y.o. (T0))
  • Self-rated measure to quantify the risk of developing psychiatric disorders(Before transition at 17 y.o. (T0))
  • Self-rated measure of impulsivity and compulsivity(Before transition at 17 y.o. (T0))
  • Self-rated measure of depressivity(Before transition at 17 y.o. (T0))
  • Self-rated measure of suicidal risk(Before transition at 17 y.o. (T0))
  • Cognitive assessment - IQ(Before transition at 17 y.o. (T0))
  • Executive functions assessment - planning task(Before transition at 17 y.o. (T0))
  • Self-rated measure of executive functions(Before transition at 17 y.o. (T0))
  • Self-rated measure of therapeutic alliance(After transition at 19 y.o. (T1))
  • Self-rated measure of transition related outcomes(After transition at 19 y.o. (T1))
  • Self-rated measure of transition readiness and appropriateness(Before transition at 17 y.o. (T0))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (8)

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