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Completed

NCT Number: NCT04333797

Psychiatry of Transition in a World in Transition

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.

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Key information

Age range

17 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brugmann University Hospital, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Risk and Protective Factors Assessment

Other

First assessment at baseline (T0) - 17 y.o. Follow-up 2 years later (T1) - 19 y.o.

Other names: Transitional care from CAMHS to AMHS

Primary outcomes

  1. 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).

  2. 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)

Secondary outcomes

  1. Self-rated measure of traumatic life events

    Time frame: Before transition at 17 y.o. (T0)

    Measured with Childhood Trauma Questionnaire (CTQ)

  2. Self-rated measure of family functioning

    Time frame: Before transition at 17 y.o. (T0)

    Measured with Family Assessment Device (FAD)

  3. Self-rated measure to quantify the risk of developing psychiatric disorders

    Time frame: Before transition at 17 y.o. (T0)

    Measured with General Health Questionnaire (GHQ-12)

  4. Self-rated measure of internalising and externalising symptoms

    Time frame: Before transition at 17 y.o. (T0)

    Measured with Youth Self Report 11-18 (YSR)

  5. Self-rated measure of impulsivity and compulsivity

    Time frame: Before transition at 17 y.o. (T0)

    Measured with Barratt Impulsiveness Scale (BIS-11)

  6. Self-rated measure of depressivity

    Time frame: Before transition at 17 y.o. (T0)

    Measured with Beck Depression Inventory-II (BDI-II)

  7. Self-rated measure of suicidal risk

    Time frame: Before transition at 17 y.o. (T0)

    Measured with Beck Scale of Suicide Ideation (BSS)

  8. Self-rated measure of emotional regulation

    Time frame: Before transition at 17 y.o. (T0)

    Measured with Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA)

  9. Self-rated measure of interpersonal relationships social adaptation

    Time frame: Before transition at 17 y.o. (T0)

    Measured with Social Adaptation Self-evaluation Scale (SASS)

  10. Self-rated measure of cognitive insight

    Time frame: Before transition at 17 y.o. (T0)

    Measured with Beck Cognitive Insight Scale (BCIS)

  11. Cognitive assessment - IQ

    Time frame: Before transition at 17 y.o. (T0)

    Measured with Wechsler Adult Intelligence Scale (WAIS-IV)

  12. Executive functions assessment - alertness, divided attention, flexibility and working memory

    Time frame: Before transition at 17 y.o. (T0)

    Measured with Test of Attentional Performance (TAP)

  13. Executive functions assessment - cognitive inhibition

    Time frame: Before transition at 17 y.o. (T0)

    Measured with STROOP Task

  14. Executive functions assessment - planning task

    Time frame: Before transition at 17 y.o. (T0)

    Measured with Tower of London Test (TOL)

  15. Self-rated measure of executive functions

    Time frame: Before transition at 17 y.o. (T0)

    Measured with Behavior Rating Inventory of Executive Function - Self report (BRIEF-SR)

  16. Self-rated measure of transition readiness and appropriateness

    Time frame: Before transition at 17 y.o. (T0)

    Measured with Transition Readiness and Appropriateness Mesure (TRAM)

  17. Self-rated measure of therapeutic alliance

    Time frame: After transition at 19 y.o. (T1)

    Measured with Helping Alliance Questionnaire (HAQ)

  18. Self-rated measure of transition related outcomes

    Time frame: After transition at 19 y.o. (T1)

    Measured with Transition Related Outcomes Mesure (TROM)

Sponsors and collaborators

Lead sponsor

Queen Fabiola Children's University Hospital

Other

Collaborators

  • Brugmann University Hospital
  • Erasme University Hospital
  • King Baudouin Foundation
  • Service santé mentale à l'ULB
  • Université Libre de Bruxelles

Registry information

Official study title

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

Acronym: Transition_psy

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 3, 2020
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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