Psychiatry of Transition in a World in Transition (Transition_psy)

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

252

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brussels, Belgium, 1020
        • Hôpital Universitaire Des Enfants Reine Fabiola
      • Brussels, Belgium, 1070
        • Erasme University Hospital
      • Brussels, Belgium, 1020
        • Brugmann University Hospital
      • Brussels, Belgium, 1050
        • Service santé mentale à l'ULB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Transitional age youth
Assessed group.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Change from Baseline HoNOSCA before transition at 17 y.o. to after transition at 19 y.o.
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 WHO-QoL before transition at 17 y.o. to after transition at 19 y.o

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-rated measure of traumatic life events
Time Frame: Before transition at 17 y.o. (T0)
Measured with Childhood Trauma Questionnaire (CTQ)
Before transition at 17 y.o. (T0)
Self-rated measure of family functioning
Time Frame: Before transition at 17 y.o. (T0)
Measured with Family Assessment Device (FAD)
Before transition at 17 y.o. (T0)
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)
Before transition at 17 y.o. (T0)
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)
Before transition at 17 y.o. (T0)
Self-rated measure of impulsivity and compulsivity
Time Frame: Before transition at 17 y.o. (T0)
Measured with Barratt Impulsiveness Scale (BIS-11)
Before transition at 17 y.o. (T0)
Self-rated measure of depressivity
Time Frame: Before transition at 17 y.o. (T0)
Measured with Beck Depression Inventory-II (BDI-II)
Before transition at 17 y.o. (T0)
Self-rated measure of suicidal risk
Time Frame: Before transition at 17 y.o. (T0)
Measured with Beck Scale of Suicide Ideation (BSS)
Before transition at 17 y.o. (T0)
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)
Before transition at 17 y.o. (T0)
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)
Before transition at 17 y.o. (T0)
Self-rated measure of cognitive insight
Time Frame: Before transition at 17 y.o. (T0)
Measured with Beck Cognitive Insight Scale (BCIS)
Before transition at 17 y.o. (T0)
Cognitive assessment - IQ
Time Frame: Before transition at 17 y.o. (T0)
Measured with Wechsler Adult Intelligence Scale (WAIS-IV)
Before transition at 17 y.o. (T0)
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)
Before transition at 17 y.o. (T0)
Executive functions assessment - cognitive inhibition
Time Frame: Before transition at 17 y.o. (T0)
Measured with STROOP Task
Before transition at 17 y.o. (T0)
Executive functions assessment - planning task
Time Frame: Before transition at 17 y.o. (T0)
Measured with Tower of London Test (TOL)
Before transition at 17 y.o. (T0)
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)
Before transition at 17 y.o. (T0)
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)
Before transition at 17 y.o. (T0)
Self-rated measure of therapeutic alliance
Time Frame: After transition at 19 y.o. (T1)
Measured with Helping Alliance Questionnaire (HAQ)
After transition at 19 y.o. (T1)
Self-rated measure of transition related outcomes
Time Frame: After transition at 19 y.o. (T1)
Measured with Transition Related Outcomes Mesure (TROM)
After transition at 19 y.o. (T1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Véronique Delvenne, MD, PhD, Queen Fabiola Children's University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2020

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

March 27, 2020

First Submitted That Met QC Criteria

April 2, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Estimated)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

June 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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