Association Between a Biological Pattern of Dysregulation of the HPA Axis and Mental Disorders in Children Exposed to Early Life Stress

NCT ID: NCT04363112

Last Updated: 2024-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-28

Study Completion Date

2024-03-04

Brief Summary

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The purpose of this study is to demonstrate an association between a biological pattern of dysregulation of the HPA axis and mental disorders in children exposed to early life stress.

Detailed Description

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The purpose of this study is to demonstrate an association between a biological pattern of dysregulation of the HPA axis and mental disorders in children exposed to early life stress.

Cortisol secretion lead to define two groups : pathologic versus normal cortisol secretion.

Mental disorders is evaluate with Mini-Kids II (a mental health questionary) and lead to define two groups : mental disorders versus no mental disorders

Conditions

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Mental Disorder, Child

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study is an monocentric, interventional, comparative uncontrolled study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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study with just one arm

All of participants are in this arm. Mini Kid II and CBCL score are administered between day 3 and 7. Moreover, salivary test will be remove to evaluate cortisol secretion, 4 time per day during 2 consecutive days.

Psychologic aftercare will be propose if children have psychologic troubles (results of Mini Kid II)

Group Type OTHER

Mini Kid II

Intervention Type BEHAVIORAL

Mini Kid II (Mini International Neuropsychiatric Interview ) is a standardised, hetero mental health questionary for children, according to DSM IV. Mini Kid II will be administered to children between day 3 and 7 during the study.

Interventions

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Mini Kid II

Mini Kid II (Mini International Neuropsychiatric Interview ) is a standardised, hetero mental health questionary for children, according to DSM IV. Mini Kid II will be administered to children between day 3 and 7 during the study.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Aged 8 to over 10 years
* To be entrust to ASE of Finistère in stable environment (the same place of residence since 6 months or more)
* French speaking
* Oral consent by children
* Informed and signed consent by tenured of parent authority

Exclusion Criteria

* Don't want to participate
* To have chronic neurologic or endocrinal pathology or don't have access to verbal language.
Minimum Eligible Age

8 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU de Brest

Brest, , France

Site Status

Countries

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France

Other Identifiers

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29BRC20.0056

Identifier Type: -

Identifier Source: org_study_id

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