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

Primary Purpose

Mental Disorder, Child

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mini Kid II
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mental Disorder, Child

Eligibility Criteria

8 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CHRU de BrestRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

study with just one arm

Arm Description

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)

Outcomes

Primary Outcome Measures

Mini Kid II : Mini International Neuropsychiatric Interview
Standardized questionary administered by a physician. There are 30 pages with 17 subjects like depression, maniac trouble, panic trouble, etc.

Secondary Outcome Measures

CBCL score : Child Behaviour Check List
CBCL Score is a hetero scale administered by host family or caseworker. It is a scale 0 (no behavior troubles) to 124 (behavior troubles).
BRIEF : Behavrioral Rating Inventory of Executive Function
Standardized questionary administered by by host family or caseworker between day 4 and 13 to the study. BRIEF questionary contains 2 themes (metacognition and Behavior regulation) with 85 items in total. Each item contains 3 answers : Never (0)/ Sometime(1)/ Always(2)

Full Information

First Posted
April 20, 2020
Last Updated
July 12, 2023
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT04363112
Brief Title
Association Between a Biological Pattern of Dysregulation of the HPA Axis and Mental Disorders in Children Exposed to Early Life Stress
Acronym
ESASP
Official Title
Association Between a Biological Pattern of Dysregulation of the HPA Axis and Mental Disorders in Children Exposed to Early Life Stress
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
October 13, 2024 (Anticipated)
Study Completion Date
October 13, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

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 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder, Child

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study is an monocentric, interventional, comparative uncontrolled study
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study with just one arm
Arm Type
Other
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Mini Kid II
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mini Kid II : Mini International Neuropsychiatric Interview
Description
Standardized questionary administered by a physician. There are 30 pages with 17 subjects like depression, maniac trouble, panic trouble, etc.
Time Frame
Day 10 to the study
Secondary Outcome Measure Information:
Title
CBCL score : Child Behaviour Check List
Description
CBCL Score is a hetero scale administered by host family or caseworker. It is a scale 0 (no behavior troubles) to 124 (behavior troubles).
Time Frame
Day 10 to the study
Title
BRIEF : Behavrioral Rating Inventory of Executive Function
Description
Standardized questionary administered by by host family or caseworker between day 4 and 13 to the study. BRIEF questionary contains 2 themes (metacognition and Behavior regulation) with 85 items in total. Each item contains 3 answers : Never (0)/ Sometime(1)/ Always(2)
Time Frame
Day 10 to the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume BRONSARD, Pr
Phone
06 17 99 88 65
Email
guillaume.bronsard@chu-brest.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre-Antoine LEROUX
Phone
06 40 25 55 65
Email
pierreantoine-leroux@live.fr
Facility Information:
Facility Name
CHRU de Brest
City
Brest Cedex
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume BRONSARD, Pr
Phone
06 17 99 88 65
Email
guillaume.bronsard@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Pierre-Antoine LEROUX
Phone
06 40 25 55 65
Email
pierreantoine-leroux@live.fr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
IPD Sharing Access Criteria
Data access requests will be reviewed by the internal committee of Brest University Hospital. Requestors will be required to sign and complete a data access agreement.

Learn more about this trial

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

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