Skip to content

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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04363112
Acronym
ESASP
Enrollment
8
Registered
2020-04-27
Start date
2022-03-28
Completion date
2024-03-04
Last updated
2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Disorder, Child

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

Interventions

BEHAVIORALMini 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.

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

The study is an monocentric, interventional, comparative uncontrolled study

Eligibility

Sex/Gender
ALL
Age
8 Years to 10 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Mini Kid II : Mini International Neuropsychiatric InterviewDay 10 to the studyStandardized questionary administered by a physician. There are 30 pages with 17 subjects like depression, maniac trouble, panic trouble, etc.

Secondary

MeasureTime frameDescription
CBCL score : Child Behaviour Check ListDay 10 to the studyCBCL 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 FunctionDay 10 to the studyStandardized 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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026