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Transitional CareTransition_psyNCT04333797

Psychiatry of Transition in a World in Transition

A study testing Risk and Protective Factors Assessment in people with Transitional Care and Mental Disorder in Adolescence, run by Queen Fabiola Children's University Hospital at 4 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 17 to 17 yearsHealthy volunteers can take part
What is being tested?
Risk and Protective Factors Assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
252 participants
Where
4 sitesBelgium
Study dates
10 Jun 2020to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

Belgium4 sites
  • Brugmann University Hospital

    Brussels, 1020

  • Hôpital Universitaire Des Enfants Reine Fabiola

    Brussels, 1020

  • Service santé mentale à l'ULB

    Brussels, 1050

  • Erasme University Hospital

    Brussels, 1070

Other trials in Belgium

About this study

Official title: 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.

Read the 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.

Being tested
Risk and Protective Factors Assessment
Keywords
Transitional age youth, CAMHS, AMHS, Dimensional approach, Child and Adolescent Psychiatry services, Adult Psychiatry services
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Risk and Protective Factors AssessmentOther

    Also called Transitional care from CAMHS to AMHS

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

Study groups in NCT04333797
Study groupRoleWhat they receive
Transitional age youthOtherAssessed group.
Receives: Other: Risk and Protective Factors Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

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

    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)

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

Secondary outcomes (18)
  1. Self-rated measure of traumatic life events

    Measured with Childhood Trauma Questionnaire (CTQ)

    Measured: Before transition at 17 y.o. (T0)

  2. Self-rated measure of family functioning

    Measured with Family Assessment Device (FAD)

    Measured: Before transition at 17 y.o. (T0)

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

    Measured with General Health Questionnaire (GHQ-12)

    Measured: Before transition at 17 y.o. (T0)

  4. Self-rated measure of internalising and externalising symptoms

    Measured with Youth Self Report 11-18 (YSR)

    Measured: Before transition at 17 y.o. (T0)

  5. Self-rated measure of impulsivity and compulsivity

    Measured with Barratt Impulsiveness Scale (BIS-11)

    Measured: Before transition at 17 y.o. (T0)

  6. Self-rated measure of depressivity

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

    Measured: Before transition at 17 y.o. (T0)

  7. Self-rated measure of suicidal risk

    Measured with Beck Scale of Suicide Ideation (BSS)

    Measured: Before transition at 17 y.o. (T0)

  8. Self-rated measure of emotional regulation

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

    Measured: Before transition at 17 y.o. (T0)

  9. Self-rated measure of interpersonal relationships social adaptation

    Measured with Social Adaptation Self-evaluation Scale (SASS)

    Measured: Before transition at 17 y.o. (T0)

  10. Self-rated measure of cognitive insight

    Measured with Beck Cognitive Insight Scale (BCIS)

    Measured: Before transition at 17 y.o. (T0)

  11. Cognitive assessment - IQ

    Measured with Wechsler Adult Intelligence Scale (WAIS-IV)

    Measured: Before transition at 17 y.o. (T0)

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

    Measured with Test of Attentional Performance (TAP)

    Measured: Before transition at 17 y.o. (T0)

  13. Executive functions assessment - cognitive inhibition

    Measured with STROOP Task

    Measured: Before transition at 17 y.o. (T0)

  14. Executive functions assessment - planning task

    Measured with Tower of London Test (TOL)

    Measured: Before transition at 17 y.o. (T0)

  15. Self-rated measure of executive functions

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

    Measured: Before transition at 17 y.o. (T0)

  16. Self-rated measure of transition readiness and appropriateness

    Measured with Transition Readiness and Appropriateness Mesure (TRAM)

    Measured: Before transition at 17 y.o. (T0)

  17. Self-rated measure of therapeutic alliance

    Measured with Helping Alliance Questionnaire (HAQ)

    Measured: After transition at 19 y.o. (T1)

  18. Self-rated measure of transition related outcomes

    Measured with Transition Related Outcomes Mesure (TROM)

    Measured: After transition at 19 y.o. (T1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2020
  2. Study start10 Jun 2020
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04333797
Sponsor's protocol ID
P2020/PSY/Transition_psy
Acronym
Transition_psy
Status last verified
Jun 2020
First submitted
27 Mar 2020
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Caspi A, Moffitt TE. All for One and One for All: Mental Disorders in One Dimension. Am J Psychiatry. 2018 Sep 1;175(9):831-844. doi: 10.1176/appi.ajp.2018.17121383. Epub 2018 Apr 6.

    PubMed 29621902
  • Tuomainen H, Schulze U, Warwick J, Paul M, Dieleman GC, Franic T, Madan J, Maras A, McNicholas F, Purper-Ouakil D, Santosh P, Signorini G, Street C, Tremmery S, Verhulst FC, Wolke D, Singh SP; MILESTONE consortium. Managing the link and strengthening transition from child to adult mental health Care in Europe (MILESTONE): background, rationale and methodology. BMC Psychiatry. 2018 Jun 4;18(1):167. doi: 10.1186/s12888-018-1758-z.

    PubMed 29866202
  • Singh SP, Paul M, Ford T, Kramer T, Weaver T. Transitions of care from Child and Adolescent Mental Health Services to Adult Mental Health Services (TRACK Study): a study of protocols in Greater London. BMC Health Serv Res. 2008 Jun 23;8:135. doi: 10.1186/1472-6963-8-135.

    PubMed 18573214
  • Hovish K, Weaver T, Islam Z, Paul M, Singh SP. Transition experiences of mental health service users, parents, and professionals in the United Kingdom: a qualitative study. Psychiatr Rehabil J. 2012 Winter;35(3):251-7. doi: 10.2975/35.3.2012.251.257.

    PubMed 22246124
  • Leebens PK, Williamson ED. Developmental Psychopathology: Risk and Resilience in the Transition to Young Adulthood. Child Adolesc Psychiatr Clin N Am. 2017 Apr;26(2):143-156. doi: 10.1016/j.chc.2016.12.001.

    PubMed 28314447
  • Singh SP, Tuomainen H. Transition from child to adult mental health services: needs, barriers, experiences and new models of care. World Psychiatry. 2015 Oct;14(3):358-61. doi: 10.1002/wps.20266. No abstract available.

    PubMed 26407794
  • Paul M, Street C, Wheeler N, Singh SP. Transition to adult services for young people with mental health needs: A systematic review. Clin Child Psychol Psychiatry. 2015 Jul;20(3):436-57. doi: 10.1177/1359104514526603. Epub 2014 Apr 7.

    PubMed 24711585
  • McGorry P, Bates T, Birchwood M. Designing youth mental health services for the 21st century: examples from Australia, Ireland and the UK. Br J Psychiatry Suppl. 2013 Jan;54:s30-5. doi: 10.1192/bjp.bp.112.119214.

    PubMed 23288499
  • Gore FM, Bloem PJ, Patton GC, Ferguson J, Joseph V, Coffey C, Sawyer SM, Mathers CD. Global burden of disease in young people aged 10-24 years: a systematic analysis. Lancet. 2011 Jun 18;377(9783):2093-102. doi: 10.1016/S0140-6736(11)60512-6. Epub 2011 Jun 7.

    PubMed 21652063
  • Kotov R, Ruggero CJ, Krueger RF, Watson D, Yuan Q, Zimmerman M. New dimensions in the quantitative classification of mental illness. Arch Gen Psychiatry. 2011 Oct;68(10):1003-11. doi: 10.1001/archgenpsychiatry.2011.107.

    PubMed 21969458
  • Kim-Cohen J, Caspi A, Moffitt TE, Harrington H, Milne BJ, Poulton R. Prior juvenile diagnoses in adults with mental disorder: developmental follow-back of a prospective-longitudinal cohort. Arch Gen Psychiatry. 2003 Jul;60(7):709-17. doi: 10.1001/archpsyc.60.7.709.

    PubMed 12860775
  • Jones PB. Adult mental health disorders and their age at onset. Br J Psychiatry Suppl. 2013 Jan;54:s5-10. doi: 10.1192/bjp.bp.112.119164.

    PubMed 23288502
  • Snyder HR, Gulley LD, Bijttebier P, Hartman CA, Oldehinkel AJ, Mezulis A, Young JF, Hankin BL. Adolescent emotionality and effortful control: Core latent constructs and links to psychopathology and functioning. J Pers Soc Psychol. 2015 Dec;109(6):1132-49. doi: 10.1037/pspp0000047. Epub 2015 May 25.

    PubMed 26011660
  • Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593.

    PubMed 15939837
  • Copeland WE, Wolke D, Shanahan L, Costello EJ. Adult Functional Outcomes of Common Childhood Psychiatric Problems: A Prospective, Longitudinal Study. JAMA Psychiatry. 2015 Sep;72(9):892-9. doi: 10.1001/jamapsychiatry.2015.0730.

    PubMed 26176785

Questions about this trial

What is this clinical trial studying?

A study testing Risk and Protective Factors Assessment in people with Transitional Care and Mental Disorder in Adolescence, run by Queen Fabiola Children's University Hospital at 4 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04333797, which also lists 57 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

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