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

NCT04363112 | Terminated

• 1 other identifier: 29BRC20.0056
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorder, Child

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• CBCL score : Child Behaviour Check List

  Day 10 to the study

• BRIEF : Behavrioral Rating Inventory of Executive Function

  Day 10 to the study

Study Arms (1)

study with just one arm

OTHER

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

Interventions

Mini Kid II BEHAVIORAL

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.

study with just one arm

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Don't want to participate
• To have chronic neurologic or endocrinal pathology or don't have access to verbal language.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is an monocentric, interventional, comparative uncontrolled study

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 27, 2020
• Study Start: March 28, 2022
• Primary Completion: March 4, 2024
• Study Completion: March 4, 2024
• Last Updated: March 21, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
• 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.

Locations

FR (1)