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

Not Applicable

Terminated

• Conditions: Mental Disorder, Child
• Interventions: Behavioral: Mini Kid II

• Registration Number: NCT04363112
• Lead Sponsor: University Hospital, Brest

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

Study Timeline

• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-27
• Study Start: 2022-03-28
• Status Verified: 2023-07
• Primary Completion: 2024-03-04
• Study Completion: 2024-03-04
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
study with just one arm	Mini Kid II	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)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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).

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest Cedex, France