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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04333797
Other study ID # P2020/PSY/Transition_psy
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 2, 2020
Est. completion date September 30, 2025

Study information

Verified date June 2020
Source Queen Fabiola Children's University Hospital
Contact Véronique Delvenne, MD, PhD
Phone +32 2 477 21 17
Email veronique.delvenne@huderf.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date September 30, 2025
Est. primary completion date September 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years to 17 Years
Eligibility 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 Design


Intervention

Other:
Risk and Protective Factors Assessment
First assessment at baseline (T0) - 17 y.o. Follow-up 2 years later (T1) - 19 y.o.

Locations

Country Name City State
Belgium Brugmann University Hospital Brussels
Belgium Erasme University Hospital Brussels
Belgium Hôpital Universitaire Des Enfants Reine Fabiola Brussels
Belgium Service santé mentale à l'ULB Brussels

Sponsors (6)

Lead Sponsor Collaborator
Queen Fabiola Children's University Hospital Brugmann University Hospital, Erasme University Hospital, King Baudouin Foundation, Service santé mentale à l'ULB, Université Libre de Bruxelles

Country where clinical trial is conducted

Belgium, 

References & Publications (54)

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* Note: There are 54 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Change from Baseline HoNOSCA before transition at 17 y.o. to after transition at 19 y.o.
Primary 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) Change from Baseline WHO-QoL before transition at 17 y.o. to after transition at 19 y.o
Secondary Self-rated measure of traumatic life events Measured with Childhood Trauma Questionnaire (CTQ) Before transition at 17 y.o. (T0)
Secondary Self-rated measure of family functioning Measured with Family Assessment Device (FAD) Before transition at 17 y.o. (T0)
Secondary Self-rated measure to quantify the risk of developing psychiatric disorders Measured with General Health Questionnaire (GHQ-12) Before transition at 17 y.o. (T0)
Secondary Self-rated measure of internalising and externalising symptoms Measured with Youth Self Report 11-18 (YSR) Before transition at 17 y.o. (T0)
Secondary Self-rated measure of impulsivity and compulsivity Measured with Barratt Impulsiveness Scale (BIS-11) Before transition at 17 y.o. (T0)
Secondary Self-rated measure of depressivity Measured with Beck Depression Inventory-II (BDI-II) Before transition at 17 y.o. (T0)
Secondary Self-rated measure of suicidal risk Measured with Beck Scale of Suicide Ideation (BSS) Before transition at 17 y.o. (T0)
Secondary Self-rated measure of emotional regulation Measured with Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA) Before transition at 17 y.o. (T0)
Secondary Self-rated measure of interpersonal relationships social adaptation Measured with Social Adaptation Self-evaluation Scale (SASS) Before transition at 17 y.o. (T0)
Secondary Self-rated measure of cognitive insight Measured with Beck Cognitive Insight Scale (BCIS) Before transition at 17 y.o. (T0)
Secondary Cognitive assessment - IQ Measured with Wechsler Adult Intelligence Scale (WAIS-IV) Before transition at 17 y.o. (T0)
Secondary Executive functions assessment - alertness, divided attention, flexibility and working memory Measured with Test of Attentional Performance (TAP) Before transition at 17 y.o. (T0)
Secondary Executive functions assessment - cognitive inhibition Measured with STROOP Task Before transition at 17 y.o. (T0)
Secondary Executive functions assessment - planning task Measured with Tower of London Test (TOL) Before transition at 17 y.o. (T0)
Secondary Self-rated measure of executive functions Measured with Behavior Rating Inventory of Executive Function - Self report (BRIEF-SR) Before transition at 17 y.o. (T0)
Secondary Self-rated measure of transition readiness and appropriateness Measured with Transition Readiness and Appropriateness Mesure (TRAM) Before transition at 17 y.o. (T0)
Secondary Self-rated measure of therapeutic alliance Measured with Helping Alliance Questionnaire (HAQ) After transition at 19 y.o. (T1)
Secondary Self-rated measure of transition related outcomes Measured with Transition Related Outcomes Mesure (TROM) After transition at 19 y.o. (T1)
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