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

Sponsor
University Hospital, Brest (Other)
Overall Status
Recruiting
CT.gov ID
NCT04363112
Collaborator
(none)
38
1
1
6.5
5.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mini Kid II
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
38 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
The study is an monocentric, interventional, comparative uncontrolled studyThe study is an monocentric, interventional, comparative uncontrolled study
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Association Between a Biological Pattern of Dysregulation of the HPA Axis and Mental Disorders in Children Exposed to Early Life Stress
Actual Study Start Date :
Mar 28, 2022
Anticipated Primary Completion Date :
Oct 13, 2022
Anticipated Study Completion Date :
Oct 13, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: 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)

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Mini Kid II : Mini International Neuropsychiatric Interview [Day 10 to the study]

    Standardized questionary administered by a physician. There are 30 pages with 17 subjects like depression, maniac trouble, panic trouble, etc.

Secondary Outcome Measures

  1. CBCL score : Child Behaviour Check List [Day 10 to the study]

    CBCL Score is a hetero scale administered by host family or caseworker. It is a scale 0 (no behavior troubles) to 124 (behavior troubles).

  2. BRIEF : Behavrioral Rating Inventory of Executive Function [Day 10 to the study]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHRU de Brest Brest Cedex France 29609

Sponsors and Collaborators

  • University Hospital, Brest

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT04363112
Other Study ID Numbers:
  • 29BRC20.0056
First Posted:
Apr 27, 2020
Last Update Posted:
Apr 15, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 15, 2022