- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04333797
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
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Brussels, Belgium, 1020
- Hôpital Universitaire Des Enfants Reine Fabiola
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Brussels, Belgium, 1070
- Erasme University Hospital
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Brussels, Belgium, 1020
- Brugmann University Hospital
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Brussels, Belgium, 1050
- Service santé mentale à l'ULB
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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:
|
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
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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)
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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)
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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)
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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)
|
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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)
|
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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)
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Before transition at 17 y.o. (T0)
|
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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)
|
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Self-rated measure of therapeutic alliance
Time Frame: After transition at 19 y.o. (T1)
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Measured with Helping Alliance Questionnaire (HAQ)
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After transition at 19 y.o. (T1)
|
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Self-rated measure of transition related outcomes
Time Frame: After transition at 19 y.o. (T1)
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Measured with Transition Related Outcomes Mesure (TROM)
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After transition at 19 y.o. (T1)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Véronique Delvenne, MD, PhD, Queen Fabiola Children's University Hospital
Publications and helpful links
General Publications
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- Pottick KJ, Bilder S, Vander Stoep A, Warner LA, Alvarez MF. US patterns of mental health service utilization for transition-age youth and young adults. J Behav Health Serv Res. 2008 Oct;35(4):373-89. doi: 10.1007/s11414-007-9080-4. Epub 2007 Nov 17.
- Singh SP, Paul M, Ford T, Kramer T, Weaver T, McLaren S, Hovish K, Islam Z, Belling R, White S. Process, outcome and experience of transition from child to adult mental healthcare: multiperspective study. Br J Psychiatry. 2010 Oct;197(4):305-12. doi: 10.1192/bjp.bp.109.075135.
- 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.
- 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.
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- 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.
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- Ormel J, Oerlemans AM, Raven D, Laceulle OM, Hartman CA, Veenstra R, Verhulst FC, Vollebergh W, Rosmalen JG, Reijneveld SA, Oldehinkel AJ. Functional outcomes of child and adolescent mental disorders. Current disorder most important but psychiatric history matters as well. Psychol Med. 2017 May;47(7):1271-1282. doi: 10.1017/S0033291716003445. Epub 2017 Jan 9.
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- Chatburn A, Coussens S, Kohler MJ. Resiliency as a mediator of the impact of sleep on child and adolescent behavior. Nat Sci Sleep. 2013 Dec 23;6:1-9. doi: 10.2147/NSS.S54913. eCollection 2013.
- Andersen SL. Commentary on the special issue on the adolescent brain: Adolescence, trajectories, and the importance of prevention. Neurosci Biobehav Rev. 2016 Nov;70:329-333. doi: 10.1016/j.neubiorev.2016.07.012. Epub 2016 Jul 14.
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- National Institute of Mental Health. The Teen Brain: Still Under Construction. Natl Inst Ment Heal [Internet]. 2011;1-10. Available from: http://www.nimh.nih.gov/health/publications/the-teen-brain-still-under-construction/index.shtml
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- Lamb, C., Hall, D., Kelvin, R., & Van Beinum M. Working at the CAMHS/Adult Interface: Good practice guidance for the provision of psychiatric services to adolescents/young adults. London R Coll Psychiatr. 2008;
- Jivanjee, P., & Kruzich J. Supports for young people with mental health conditions and their families in the transition years. Best Pract Ment Health. 2011;7(1):115-33.
- Blum RW, Garell D, Hodgman CH, Jorissen TW, Okinow NA, Orr DP, Slap GB. Transition from child-centered to adult health-care systems for adolescents with chronic conditions. A position paper of the Society for Adolescent Medicine. J Adolesc Health. 1993 Nov;14(7):570-6. doi: 10.1016/1054-139x(93)90143-d. No abstract available.
- Cosgrave EM, Yung AR, Killackey EJ, Buckby JA, Godfrey KA, Stanford CA, et al. Met and unmet need in youth mental health. J Ment Heal [Internet]. 2008 Jan 6;17(6):618-28. Available from: http://www.tandfonline.com/doi/full/10.1080/09638230701506267
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- Beck A, Steer R, Brown G. Beck depression inventory-II. San Antonio. 1996;78(2):490.
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- Gosling CJ, Noblecourt K, Moutier S. Questionnaire de régulation émotionnelle pour enfants et adolescents. Enfance. 2018;N°2(2):291.
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- Reis J, Marchini S, De Leeuw A, Slama H, Leys C, Delhaye M, Kornreich C, Nicolis H, Delvenne V. Study Protocol: Transition_psy a Multicenter Prospective Longitudinal Cohort Study Assessing Risk and Protective Factors to Develop Psychopathology in Transitional Age Youth in Belgium. Front Psychiatry. 2021 Jun 21;12:645679. doi: 10.3389/fpsyt.2021.645679. eCollection 2021.
- 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.
- 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.
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- Marchini S, Reis J, Ben-Shaool E, Delhaye M, Kornreich C, Nicolis H, Slama H, Leys C, Delvenne V. Dimensional model on how familial vulnerability and environmental factors impact transitional age youth psychopathology: The Transition_psy study. Front Psychiatry. 2023 Mar 23;14:1103030. doi: 10.3389/fpsyt.2023.1103030. eCollection 2023.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavior
- Personal Satisfaction
- Psychological Well-Being
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Mathematical Concepts
- Statistics as Topic
- Probability
- Risk
Other Study ID Numbers
- P2020/PSY/Transition_psy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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