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

Mental Disorder, Child Clinical Trial

— ESASP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04363112
• Other study ID #: 29BRC20.0056
• Status: Terminated
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: March 4, 2024

Study information

• Verified date: July 2023
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: March 4, 2024
• Est. primary completion date: March 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorder, Child
• Mental Disorders
• Neurodevelopmental Disorders
• Psychotic Disorders
• Stress, Psychological

Intervention

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.

Locations

Country	Name	City	State
France	CHRU de Brest	Brest Cedex

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 10 to the study
Secondary	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).	Day 10 to the study
Secondary	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)	Day 10 to the study