Clinical trial NCT04333797: Psychiatry of Transition in a World in Transition
Official title: Multicentre Prospective Interventional Cohort Study Assessing Risk and Protective Factors to Develop Psychopathology in Transitional Age Youth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transitional Care
Mental Disorder in Adolescence
Mental Health
Keywords: Transitional age youth
CAMHS
AMHS
Dimensional approach
Child and Adolescent Psychiatry services
Adult Psychiatry services
Lead sponsor: Queen Fabiola Children's University Hospital
Sponsor class: OTHER
Collaborators: name: Erasme University Hospital
name: Brugmann University Hospital
name: Service santé mentale à l'ULB
name: Université Libre de Bruxelles
name: King Baudouin Foundation
First posted: 2020-04-03
Enrollment: 300
Sex: ALL
Minimum age (years): 17
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline self-rated mental health status (need for care) at 2 years
timeFrame: Change from Baseline HoNOSCA before transition at 17 y.o. to after transition at 19 y.o.
measure: Change from Baseline self-rated measure of quality of life at 2 years
timeFrame: Change from Baseline WHO-QoL before transition at 17 y.o. to after transition at 19 y.o
Secondary outcomes:
measure: Self-rated measure of traumatic life events
timeFrame: Before transition at 17 y.o. (T0)
measure: Self-rated measure of family functioning
timeFrame: Before transition at 17 y.o. (T0)
measure: Self-rated measure to quantify the risk of developing psychiatric disorders
timeFrame: Before transition at 17 y.o. (T0)
measure: Self-rated measure of internalising and externalising symptoms
timeFrame: Before transition at 17 y.o. (T0)
measure: Self-rated measure of impulsivity and compulsivity
timeFrame: Before transition at 17 y.o. (T0)
measure: Self-rated measure of depressivity
timeFrame: Before transition at 17 y.o. (T0)
measure: Self-rated measure of suicidal risk
timeFrame: Before transition at 17 y.o. (T0)
measure: Self-rated measure of emotional regulation
timeFrame: Before transition at 17 y.o. (T0)
measure: Self-rated measure of interpersonal relationships social adaptation
timeFrame: Before transition at 17 y.o. (T0)
measure: Self-rated measure of cognitive insight
timeFrame: Before transition at 17 y.o. (T0)
measure: Cognitive assessment - IQ
timeFrame: Before transition at 17 y.o. (T0)
measure: Executive functions assessment - alertness, divided attention, flexibility and working memory
timeFrame: Before transition at 17 y.o. (T0)
measure: Executive functions assessment - cognitive inhibition
timeFrame: Before transition at 17 y.o. (T0)
measure: Executive functions assessment - planning task
timeFrame: Before transition at 17 y.o. (T0)
measure: Self-rated measure of executive functions
timeFrame: Before transition at 17 y.o. (T0)
measure: Self-rated measure of transition readiness and appropriateness
timeFrame: Before transition at 17 y.o. (T0)
measure: Self-rated measure of therapeutic alliance
timeFrame: After transition at 19 y.o. (T1)
measure: Self-rated measure of transition related outcomes
timeFrame: After transition at 19 y.o. (T1)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Brugmann University Hospital
city: Brussels
country: Belgium
facility: Hôpital Universitaire Des Enfants Reine Fabiola
city: Brussels
country: Belgium
facility: Service santé mentale à l'ULB
city: Brussels
country: Belgium
facility: Erasme University Hospital
Study officials:
affiliation: Queen Fabiola Children's University Hospital
name: Véronique Delvenne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Kessler RC, Amminger GP, Aguilar-Gaxiola S, Alonso J, Lee S, Ustun TB. Age of onset of mental disorders: a review of recent literature. Curr Opin Psychiatry. 2007 Jul;20(4):359-64. doi: 10.1097/YCO.0b013e32816ebc8c.
citation: Paus T, Keshavan M, Giedd JN. Why do many psychiatric disorders emerge during adolescence? Nat Rev Neurosci. 2008 Dec;9(12):947-57. doi: 10.1038/nrn2513. Epub 2008 Nov 12.
citation: 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.
citation: 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.
citation: Georgieff N. L'adolescence à l'épreuve de la neurobiologie ? Adolescence [Internet]. 2013;T.31 1(1):185. Available from: http://www.cairn.info/revue-adolescence-2013-1-page-185.htm
citation: 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
citation: Copeland W, Shanahan L, Costello EJ, Angold A. Cumulative prevalence of psychiatric disorders by young adulthood: a prospective cohort analysis from the Great Smoky Mountains Study. J Am Acad Child Adolesc Psychiatry. 2011 Mar;50(3):252-61. doi: 10.1016/j.jaac.2010.12.014. Epub 2011 Jan 26.
citation: 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;
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: Singh SP. Transition of care from child to adult mental health services: the great divide. Curr Opin Psychiatry. 2009 Jul;22(4):386-90. doi: 10.1097/YCO.0b013e32832c9221.
citation: Achenbach T. Youth Self-Report Form and Profile for Ages 11-18 (YSR/11-18). Itaca, Ill Riverside. 1991;
citation: Patton JH, Stanford MS, Barratt ES. Factor structure of the Barratt impulsiveness scale. J Clin Psychol. 1995 Nov;51(6):768-74. doi: 10.1002/1097-4679(199511)51:63.0.co;2-1.
citation: Beck A, Steer R, Brown G. Beck depression inventory-II. San Antonio. 1996;78(2):490.
citation: Beck A, Steer R. BSS: Beck scale for suicide ideation. Psychol Corp. 1991;
citation: Gosling CJ, Noblecourt K, Moutier S. Questionnaire de régulation émotionnelle pour enfants et adolescents. Enfance. 2018;N°2(2):291.
citation: Goldberg D, Williams P. General health questionnaire (GHQ). Swindon, Wiltshire, UK nferNelson. 2000
citation: Gowers SG, Harrington RC, Whitton A, Lelliott P, Beevor A, Wing J, Jezzard R. Brief scale for measuring the outcomes of emotional and behavioural disorders in children. Health of the Nation Outcome Scales for children and Adolescents (HoNOSCA). Br J Psychiatry. 1999 May;174:413-6. doi: 10.1192/bjp.174.5.413.
citation: Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
citation: Bernstein DP, Ahluvalia T, Pogge D, Handelsman L. Validity of the Childhood Trauma Questionnaire in an adolescent psychiatric population. J Am Acad Child Adolesc Psychiatry. 1997 Mar;36(3):340-8. doi: 10.1097/00004583-199703000-00012.
citation: Epstein NB, Baldwin LM, Bishop DS. The McMaster Family Assessment Device. J Marital Fam Ther [Internet]. 1983 Apr;9(2):171-80. Available from: http://doi.wiley.com/10.1111/j.1752-0606.1983.tb01497.x
citation: Bosc M, Dubini A, Polin V. Development and validation of a social functioning scale, the Social Adaptation Self-evaluation Scale. Eur Neuropsychopharmacol. 1997 Apr;7 Suppl 1:S57-70; discussion S71-3. doi: 10.1016/s0924-977x(97)00420-3.
citation: Beck AT, Baruch E, Balter JM, Steer RA, Warman DM. A new instrument for measuring insight: the Beck Cognitive Insight Scale. Schizophr Res. 2004 Jun 1;68(2-3):319-29. doi: 10.1016/S0920-9964(03)00189-0.
citation: Singh SP, Tuomainen H, Girolamo G, Maras A, Santosh P, McNicholas F, Schulze U, Purper-Ouakil D, Tremmery S, Franic T, Madan J, Paul M, Verhulst FC, Dieleman GC, Warwick J, Wolke D, Street C, Daffern C, Tah P, Griffin J, Canaway A, Signorini G, Gerritsen S, Adams L, O'Hara L, Aslan S, Russet F, Davidovic N, Tuffrey A, Wilson A, Gatherer C, Walker L; MILESTONE Consortium. Protocol for a cohort study of adolescent mental health service users with a nested cluster randomised controlled trial to assess the clinical and cost-effectiveness of managed transition in improving transitions from child to adult mental health services (the MILESTONE study). BMJ Open. 2017 Oct 16;7(10):e016055. doi: 10.1136/bmjopen-2017-016055.
citation: Wechsler D. Wechsler adult intelligence scale, 4th ed. San Antonio, TX Pearson. 2008
citation: Ryan JJ, Kreiner DS, Gontkovsky ST, Glass Umfleet L. Classification Accuracy of Sequentially Administered WAIS-IV Short Forms. Appl Neuropsychol Adult. 2015;22(6):409-14. doi: 10.1080/23279095.2014.953677. Epub 2015 Mar 18.
citation: Zimmermann P, Fimm B. Tests d'évaluation de l'attention (TEA). Würselen: Psytest. 1994
citation: Stroop JR. Studies of interference in serial verbal reactions. J Exp Psychol [Internet]. 1935;18(6):643-62. Available from: http://content.apa.org/journals/xge/18/6/643
citation: MacLeod CM. Half a century of research on the Stroop effect: an integrative review. Psychol Bull. 1991 Mar;109(2):163-203. doi: 10.1037/0033-2909.109.2.163. No abstract available.
citation: Roussel M, Goldefroy O. La batterie GREFEX: données normatives. Fonct exécutives Pathol Neurol Psychiatr. 2008;231-52.
citation: Shallice T. Specific impairments of planning. Philos Trans R Soc Lond B Biol Sci. 1982 Jun 25;298(1089):199-209. doi: 10.1098/rstb.1982.0082.
citation: Coyette F, Van der Linden M. Adaptation de l'Épreuve de la Tour de Londres. Unpubl Doc Cent Revalidation Neuropsychol des Clin Univ Saint-Luc, Bruxelles Serv Neuropsychol l'Université Liege, Belgium. 1993
citation: Gioia GA, Isquith PK. Behavior Rating Inventory for Executive Functions. In: Kreutzer JS, DeLuca J, Caplan B, editors. Encyclopedia of Clinical Neuropsychology [Internet]. New York, NY: Springer New York; 2011. p. 372-6. Available from: http://link.springer.com/10.1007/978-0-387-79948-3
citation: Kermarrec S, Kabuth B, Bursztejn C, Guillemin F. French adaptation and validation of the helping alliance questionnaires for child, parents, and therapist. Can J Psychiatry. 2006 Dec;51(14):913-22. doi: 10.1177/070674370605101407.
citation: Luborsky L, Barber JP, Siqueland L, Johnson S, Najavits LM, Frank A, Daley D. The Revised Helping Alliance Questionnaire (HAq-II) : Psychometric Properties. J Psychother Pract Res. 1996 Summer;5(3):260-71.
citation: 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.