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Developmental Psychopathology and the Gene-environment Interaction (TwinAger)

Primary Purpose

Developmental Psychological Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
MRI
Clinical and Neuropsychological evaluations
Drawing DNA sample
Sponsored by
IRCCS Eugenio Medea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Developmental Psychological Disorder

Eligibility Criteria

15 Years - 35 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • participants who already took part to the previous baseline evaluations carried out in our centers and signed consent to be contacted for future follow up

Exclusion Criteria:

  • Current or previous neurological illness or trauma that involved the brain.
  • Sensory impairments that can hamper the correct execution of the neurocognitive tasks and interviews.
  • Intellectual disability (i.e. IQ<70 as estimated with the Wechsler Adult Intelligence Scale or the Wechsler Intelligence Scale for Children)

Sites / Locations

  • IRCCS E.MedeaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Clinical, neuropsychological and MRI evaluations

Arm Description

Outcomes

Primary Outcome Measures

Magnetic Resonance (MRI) of the Brain - MRI signal allowing tridimensional multiplanar reconstruction of the brain's structures
anatomical images obtained with high definition T1 weighted sequences of radio frequencies - the measure is a "signal (in Hz) to noise ratio" which is obtained from each voxel (tiny 3D portions of the brain)
MRI signal measuring the diffusion of weather particles across brain connections - Diffusion Tensor Imagning (DTI)
measures of the brain microstructure and connectivity - as in all MRI techniques, the measure is a "signal (in Hz) to noise ratio" which is obtained from each voxel (tiny 3D portions of the brain)
Functional Magnetic Resonance (fMRI) - MRI signal allowing to measure local brain's activity
BOLD signal reflecting the brain activity that is concurrent to the execution of the Continuous Performance Test associated to emotional stimuli, as well as at rest - as in all MRI techniques, the measure is a "signal (in Hz) to noise ratio" which is obtained from each voxel (tiny 3D portions of the brain)
clinical evaluation by mean of structures interviews - different interviews have different scales. In most of the cases the presence/absence of a psychiatric symptom is evaluated
diagnosis or scores reflecting the degree of the presence or absence of a psychopathological condition or reflecting the personal temperament - The measures may vary on scales, for the most part the presence/absence (0-1) is recorded
neurocognitive evaluation - tests assessing general IQ, ability to produce words, drawing skills, attention's ability, memory.
the output vary according to the test - they are accuracy scores (number of correct answers) or reaction times (milliseconds)
sample of saliva
DNA single-nucleotide polymorphism from

Secondary Outcome Measures

Full Information

First Posted
March 30, 2020
Last Updated
July 24, 2020
Sponsor
IRCCS Eugenio Medea
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1. Study Identification

Unique Protocol Identification Number
NCT04489069
Brief Title
Developmental Psychopathology and the Gene-environment Interaction
Acronym
TwinAger
Official Title
Multimodal and Multi-source Study of Developmental Psychopathology in Twin and Youth Cohorts: Integration of Neuroimaging, Neuropsychology and Gene-environment Measures
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 16, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Eugenio Medea

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
The present is a followup study that aims at investigating the effect of genetic and environmental factors on the possible development of psychopathological conditions in a longitudinal perspective. The final goal is to understand those factors that causing vulnerability to mental illness, eventually allowing better prevention and early detections of those persons with mental illness.
Detailed Description
The developmental psychopathology aims at studying the possible paths that psychiatric conditions may take from childhood, through adolescence till early adulthood. This developmental perspective has the final goal of allowing prevention and early detection of mental illness, which in turn should translate into better prognosis and outcomes. Longitudinal research allows a better grasp on the illness etiology as it gives the opportunity of directly investigate the possible causal mechanisms and of defining the origins of psychopathological condition in adults. Many factors of risk interact, across neurodevelopment, in determining the person's vulnerability to mental illness. For instance, temperament and psychopathological factors were proved to have a role. However, the existing knowledge is still fragmented and should be integrated by new knowledge on genetic and environmental factors. Thus, combining observations of neurodevelopment, as measured with neuro-imaging techniques at subsequent timepoints, with psychopathological and neuropsychological evaluations, as well as with detailed information on genetic, environmental and temperamental indexes, is crucial, as no similar exhaustive investigations are still available. Furthermore, it must be bared in mind that the gene by environment interaction generates complex epigenetic effects on neurodevelopment, which should be monitored through a longer time lapse. This topic has been studying this topic for years, by research groups with sites in Friuli Venezia Giulia and Bosisio Parini (Lecco, Lombardia), by mean of cross-sectional and longitudinal studies, involving samples of children and adolescents at risk of psychopathology and referred because of behavioral and/or emotional difficulties, experienced in the past or still ongoing. Also, the research involved a cohort of Twins recruited from the normal population and whose data would allow more fine tuned analyses of the bene by environment interaction. In those first phases of study, instruments assessing the psychopathological risk were adapted to the Italian population and the associated cognitive marker were identified. Also, some analysis investigated the effect of the environment on the psychopathological risk. Moreover, the influence of genetic factors is under now study, mainly focussing on epigenetic factors. The research that is presented here is the followup of the previous investigations. In the previous year (2019) 33 participants underwent the follow up from the sample of children at psychopathological risk and who were chidden/adolescents at the time of the baseline evaluation. During the current year the Twins cohort will be followed up. Half or more of the participants tested ad the baseline are expected to participate, which correspond to about 30 couples (60 participants). The subjects will undergo i) a magnetic resonance, including structural MRI, DTI, resting state fMRI, fMRI (during the fMRI sequences a concurrent task, tapping attention and emotional processes, is presented); ii) a psychopathological evaluation; iii) a self-rating evaluation, filling questionnaires measuring temperaments and assessing the possible presence of behavioral problems; iv) a neurocognitive evaluation; v) a drawing of biological-genetic sample (saliva).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Psychological Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clinical, neuropsychological and MRI evaluations
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI
Intervention Description
Magnetic Resonance Imaging (sturctural MRI, fMRI resting state and task related, DTI)
Intervention Type
Diagnostic Test
Intervention Name(s)
Clinical and Neuropsychological evaluations
Intervention Description
Clinical interviews and neuropsychological tests (paper/pencil and computer based)
Intervention Type
Diagnostic Test
Intervention Name(s)
Drawing DNA sample
Intervention Description
Saliva sample
Primary Outcome Measure Information:
Title
Magnetic Resonance (MRI) of the Brain - MRI signal allowing tridimensional multiplanar reconstruction of the brain's structures
Description
anatomical images obtained with high definition T1 weighted sequences of radio frequencies - the measure is a "signal (in Hz) to noise ratio" which is obtained from each voxel (tiny 3D portions of the brain)
Time Frame
10 minutes
Title
MRI signal measuring the diffusion of weather particles across brain connections - Diffusion Tensor Imagning (DTI)
Description
measures of the brain microstructure and connectivity - as in all MRI techniques, the measure is a "signal (in Hz) to noise ratio" which is obtained from each voxel (tiny 3D portions of the brain)
Time Frame
10 minutes
Title
Functional Magnetic Resonance (fMRI) - MRI signal allowing to measure local brain's activity
Description
BOLD signal reflecting the brain activity that is concurrent to the execution of the Continuous Performance Test associated to emotional stimuli, as well as at rest - as in all MRI techniques, the measure is a "signal (in Hz) to noise ratio" which is obtained from each voxel (tiny 3D portions of the brain)
Time Frame
20 minutes
Title
clinical evaluation by mean of structures interviews - different interviews have different scales. In most of the cases the presence/absence of a psychiatric symptom is evaluated
Description
diagnosis or scores reflecting the degree of the presence or absence of a psychopathological condition or reflecting the personal temperament - The measures may vary on scales, for the most part the presence/absence (0-1) is recorded
Time Frame
2 hours
Title
neurocognitive evaluation - tests assessing general IQ, ability to produce words, drawing skills, attention's ability, memory.
Description
the output vary according to the test - they are accuracy scores (number of correct answers) or reaction times (milliseconds)
Time Frame
2 hours
Title
sample of saliva
Description
DNA single-nucleotide polymorphism from
Time Frame
>10 minutes for drawing the sample

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: participants who already took part to the previous baseline evaluations carried out in our centers and signed consent to be contacted for future follow up Exclusion Criteria: Current or previous neurological illness or trauma that involved the brain. Sensory impairments that can hamper the correct execution of the neurocognitive tasks and interviews. Intellectual disability (i.e. IQ<70 as estimated with the Wechsler Adult Intelligence Scale or the Wechsler Intelligence Scale for Children)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carolina Bonivento, PhD
Phone
‭+39 0432 559148
Email
carolina.bonivento@lanostrafamiglia.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolina Bonivento, PhD
Organizational Affiliation
IRCCS E.Medea
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS E.Medea
City
San Vito Al Tagliamento
State/Province
Pordenone
ZIP/Postal Code
33078
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolina Bonivento, PhD
Phone
+39 0432 559148‬
Email
carolina.bonivento@lanostrafamiglia.it

12. IPD Sharing Statement

Plan to Share IPD
No

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Developmental Psychopathology and the Gene-environment Interaction

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