Back to resultsPsychiatry of Transition in a World in Transition (Transition_psy)
Primary Purpose
Transitional Care, Mental Disorder in Adolescence, Mental Health
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Risk and Protective Factors Assessment
Sponsored by
About this trial
This is an interventional prevention trial for Transitional Care focused on measuring Transitional age youth, CAMHS, AMHS, Dimensional approach, Child and Adolescent Psychiatry services, Adult Psychiatry services
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
Sites / Locations
- Brugmann University HospitalRecruiting
- Hôpital Universitaire Des Enfants Reine FabiolaRecruiting
- Service santé mentale à l'ULBRecruiting
- Erasme University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Transitional age youth
Arm Description
Assessed group.
Outcomes
Primary Outcome Measures
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 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)
Secondary Outcome Measures
Self-rated measure of traumatic life events
Measured with Childhood Trauma Questionnaire (CTQ)
Self-rated measure of family functioning
Measured with Family Assessment Device (FAD)
Self-rated measure to quantify the risk of developing psychiatric disorders
Measured with General Health Questionnaire (GHQ-12)
Self-rated measure of internalising and externalising symptoms
Measured with Youth Self Report 11-18 (YSR)
Self-rated measure of impulsivity and compulsivity
Measured with Barratt Impulsiveness Scale (BIS-11)
Self-rated measure of depressivity
Measured with Beck Depression Inventory-II (BDI-II)
Self-rated measure of suicidal risk
Measured with Beck Scale of Suicide Ideation (BSS)
Self-rated measure of emotional regulation
Measured with Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA)
Self-rated measure of interpersonal relationships social adaptation
Measured with Social Adaptation Self-evaluation Scale (SASS)
Self-rated measure of cognitive insight
Measured with Beck Cognitive Insight Scale (BCIS)
Cognitive assessment - IQ
Measured with Wechsler Adult Intelligence Scale (WAIS-IV)
Executive functions assessment - alertness, divided attention, flexibility and working memory
Measured with Test of Attentional Performance (TAP)
Executive functions assessment - cognitive inhibition
Measured with STROOP Task
Executive functions assessment - planning task
Measured with Tower of London Test (TOL)
Self-rated measure of executive functions
Measured with Behavior Rating Inventory of Executive Function - Self report (BRIEF-SR)
Self-rated measure of transition readiness and appropriateness
Measured with Transition Readiness and Appropriateness Mesure (TRAM)
Self-rated measure of therapeutic alliance
Measured with Helping Alliance Questionnaire (HAQ)
Self-rated measure of transition related outcomes
Measured with Transition Related Outcomes Mesure (TROM)
Full Information
NCT ID
NCT04333797
First Posted
March 27, 2020
Last Updated
June 4, 2020
Sponsor
Queen Fabiola Children's University Hospital
Collaborators
Erasme University Hospital, Brugmann University Hospital, Service santé mentale à l'ULB, Université Libre de Bruxelles, King Baudouin Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04333797
Brief Title
Psychiatry of Transition in a World in Transition
Acronym
Transition_psy
Official Title
Multicentre Prospective Interventional Cohort Study Assessing Risk and Protective Factors to Develop Psychopathology in Transitional Age Youth
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2020 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Fabiola Children's University Hospital
Collaborators
Erasme University Hospital, Brugmann University Hospital, Service santé mentale à l'ULB, Université Libre de Bruxelles, King Baudouin Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transitional Care, Mental Disorder in Adolescence, Mental Health
Keywords
Transitional age youth, CAMHS, AMHS, Dimensional approach, Child and Adolescent Psychiatry services, Adult Psychiatry services
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transitional age youth
Arm Type
Other
Arm Description
Assessed group.
Intervention Type
Other
Intervention Name(s)
Risk and Protective Factors Assessment
Other Intervention Name(s)
Transitional care from CAMHS to AMHS
Intervention Description
First assessment at baseline (T0) - 17 y.o. Follow-up 2 years later (T1) - 19 y.o.
Primary Outcome Measure Information:
Title
Change from Baseline self-rated mental health status (need for care) at 2 years
Description
Measured at baseline (T0) and follow-up (T1) with the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA).
Time Frame
Change from Baseline HoNOSCA before transition at 17 y.o. to after transition at 19 y.o.
Title
Change from Baseline self-rated measure of quality of life at 2 years
Description
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)
Time Frame
Change from Baseline WHO-QoL before transition at 17 y.o. to after transition at 19 y.o
Secondary Outcome Measure Information:
Title
Self-rated measure of traumatic life events
Description
Measured with Childhood Trauma Questionnaire (CTQ)
Time Frame
Before transition at 17 y.o. (T0)
Title
Self-rated measure of family functioning
Description
Measured with Family Assessment Device (FAD)
Time Frame
Before transition at 17 y.o. (T0)
Title
Self-rated measure to quantify the risk of developing psychiatric disorders
Description
Measured with General Health Questionnaire (GHQ-12)
Time Frame
Before transition at 17 y.o. (T0)
Title
Self-rated measure of internalising and externalising symptoms
Description
Measured with Youth Self Report 11-18 (YSR)
Time Frame
Before transition at 17 y.o. (T0)
Title
Self-rated measure of impulsivity and compulsivity
Description
Measured with Barratt Impulsiveness Scale (BIS-11)
Time Frame
Before transition at 17 y.o. (T0)
Title
Self-rated measure of depressivity
Description
Measured with Beck Depression Inventory-II (BDI-II)
Time Frame
Before transition at 17 y.o. (T0)
Title
Self-rated measure of suicidal risk
Description
Measured with Beck Scale of Suicide Ideation (BSS)
Time Frame
Before transition at 17 y.o. (T0)
Title
Self-rated measure of emotional regulation
Description
Measured with Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA)
Time Frame
Before transition at 17 y.o. (T0)
Title
Self-rated measure of interpersonal relationships social adaptation
Description
Measured with Social Adaptation Self-evaluation Scale (SASS)
Time Frame
Before transition at 17 y.o. (T0)
Title
Self-rated measure of cognitive insight
Description
Measured with Beck Cognitive Insight Scale (BCIS)
Time Frame
Before transition at 17 y.o. (T0)
Title
Cognitive assessment - IQ
Description
Measured with Wechsler Adult Intelligence Scale (WAIS-IV)
Time Frame
Before transition at 17 y.o. (T0)
Title
Executive functions assessment - alertness, divided attention, flexibility and working memory
Description
Measured with Test of Attentional Performance (TAP)
Time Frame
Before transition at 17 y.o. (T0)
Title
Executive functions assessment - cognitive inhibition
Description
Measured with STROOP Task
Time Frame
Before transition at 17 y.o. (T0)
Title
Executive functions assessment - planning task
Description
Measured with Tower of London Test (TOL)
Time Frame
Before transition at 17 y.o. (T0)
Title
Self-rated measure of executive functions
Description
Measured with Behavior Rating Inventory of Executive Function - Self report (BRIEF-SR)
Time Frame
Before transition at 17 y.o. (T0)
Title
Self-rated measure of transition readiness and appropriateness
Description
Measured with Transition Readiness and Appropriateness Mesure (TRAM)
Time Frame
Before transition at 17 y.o. (T0)
Title
Self-rated measure of therapeutic alliance
Description
Measured with Helping Alliance Questionnaire (HAQ)
Time Frame
After transition at 19 y.o. (T1)
Title
Self-rated measure of transition related outcomes
Description
Measured with Transition Related Outcomes Mesure (TROM)
Time Frame
After transition at 19 y.o. (T1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Véronique Delvenne, MD, PhD
Phone
+32 2 477 21 17
Email
veronique.delvenne@huderf.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Véronique Delvenne, MD, PhD
Organizational Affiliation
Queen Fabiola Children's University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brugmann University Hospital
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Kornreich, MDPhD
Phone
0032 2 477.27.05
First Name & Middle Initial & Last Name & Degree
Charles Kornreich, MDPhD
First Name & Middle Initial & Last Name & Degree
Anthony De Leeuw, MD
Facility Name
Hôpital Universitaire Des Enfants Reine Fabiola
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique Delvenne, MDPhD
Phone
0032 2 477 21 17
First Name & Middle Initial & Last Name & Degree
Véronique Delvenne, MDPhD
First Name & Middle Initial & Last Name & Degree
Joana Reis, MD
Facility Name
Service santé mentale à l'ULB
City
Brussels
ZIP/Postal Code
1050
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène Nicolis, MD
Phone
0032 2 650.59.26
First Name & Middle Initial & Last Name & Degree
Hélène Nicolis, MD
Facility Name
Erasme University Hospital
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Delhaye, MDPhD
Phone
0032.2.555.27.40
First Name & Middle Initial & Last Name & Degree
Marie Delhaye, MDPhD
First Name & Middle Initial & Last Name & Degree
Simone Marchini, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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