Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
Study NCT ID:
NCT06823492
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2024-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigating the Impacts of Early Life Experience on the Brain & Behaviour
Sponsor:
University of Manchester
Organization:
Study Overview
Official Title:
Effects of Early Trauma on Neurocognitive Development and Mental Health
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to learn more about how early life experience influences the brain, behaviour, and the immune system later in life. This will help improve understanding of why certain early life experiences (e.g., adoption, stress and parental separation) can cause difficulties for some people when they are adults. The long-term goal of this research is to develop tools that could identify young people who are vulnerable to developing future problems, this will ensure people get the help that they need at the right time for them.
This study will use psychological assessment, online games, brain imaging and blood sampling to help improve our understanding of how and why early life experience can influence mental health, cognition, brain development and the immune system later in life.
This study will use psychological assessment, online games, brain imaging and blood sampling to help improve our understanding of how and why early life experience can influence mental health, cognition, brain development and the immune system later in life.
Detailed Description:
Step 1: Telephone/Video screening call (20 minutes)
The first part of this study is a brief telephone/video call during which you will:
* Be asked questions to check whether you meet the study eligibility criteria.
* Be asked questions about your medical history (including mental health) and use of psychiatric medication.
Step 2: ONLINE PARTS OF THE STUDY (3 hours) Once you have completed the online consent form you will be emailed a link to the online parts of the study.
* You will be asked to fill in three online questionnaires which take around 30 minutes each and collect information about your demographics (e.g., sex, job, ethnicity, income etc.,), medical history, mental health conditions (e.g., autism spectrum quotient (you may opt of this questionnaire), depression, anxiety, addiction, drug and alcohol use) and personality traits (e.g., impulsivity, attachment, neuroticism, extraversion).
* You will be asked to complete online games which are designed to assess memory, impulsivity, attention, face recognition and social interaction. These short tasks (5 - 10 minutes each) are similar to simple "brain training" games you may have seen online. They will take around 1.5 hours to complete in total.
Step 3: FACE-TO-FACE PARTS OF THE STUDY (2-hours)
BRAIN SCAN (1.5 hours)
* When you arrive, you will be asked to review this study information sheet and sign a paper consent form and other safety/screening forms required for the study.
* You will then be asked to take part in a magnetic resonance imaging (MRI) brain scan. You will be asked to lie down in a strong magnetic field for an hour whilst a computer takes pictures of your brain, and you complete short cognitive tasks (3 x 10 minutes each) and a resting state brain scan (10 minutes).
BLOOD TEST (30 minutes) We would also like to collect a blood sample from you, as this will help us understand how early life events can impact your white blood cells which are a key part of your immune system.
Step 4: INTERVIEWS, QUESTIONNAIRES \& MEMORY GAME (1.5 - 3 hours)
You can choose to do the following parts of the study either when you visit the University of Manchester or during a remote session (Zoom/telephone).
* The researcher will conduct interviews about your mental health history and your experience of friendships and relationships (up 2.5 hours).
* You will be asked to complete a short, anonymised questionnaires about your experience of trauma and stress in your childhood including the Childhood Trauma Questionnaire and the Adverse Childhood Experiences questionnaire (15 minutes).
* You will complete a short emotional memory game (on the researchers' laptop or via your computer if via Zoom) (5 minutes).
The first part of this study is a brief telephone/video call during which you will:
* Be asked questions to check whether you meet the study eligibility criteria.
* Be asked questions about your medical history (including mental health) and use of psychiatric medication.
Step 2: ONLINE PARTS OF THE STUDY (3 hours) Once you have completed the online consent form you will be emailed a link to the online parts of the study.
* You will be asked to fill in three online questionnaires which take around 30 minutes each and collect information about your demographics (e.g., sex, job, ethnicity, income etc.,), medical history, mental health conditions (e.g., autism spectrum quotient (you may opt of this questionnaire), depression, anxiety, addiction, drug and alcohol use) and personality traits (e.g., impulsivity, attachment, neuroticism, extraversion).
* You will be asked to complete online games which are designed to assess memory, impulsivity, attention, face recognition and social interaction. These short tasks (5 - 10 minutes each) are similar to simple "brain training" games you may have seen online. They will take around 1.5 hours to complete in total.
Step 3: FACE-TO-FACE PARTS OF THE STUDY (2-hours)
BRAIN SCAN (1.5 hours)
* When you arrive, you will be asked to review this study information sheet and sign a paper consent form and other safety/screening forms required for the study.
* You will then be asked to take part in a magnetic resonance imaging (MRI) brain scan. You will be asked to lie down in a strong magnetic field for an hour whilst a computer takes pictures of your brain, and you complete short cognitive tasks (3 x 10 minutes each) and a resting state brain scan (10 minutes).
BLOOD TEST (30 minutes) We would also like to collect a blood sample from you, as this will help us understand how early life events can impact your white blood cells which are a key part of your immune system.
Step 4: INTERVIEWS, QUESTIONNAIRES \& MEMORY GAME (1.5 - 3 hours)
You can choose to do the following parts of the study either when you visit the University of Manchester or during a remote session (Zoom/telephone).
* The researcher will conduct interviews about your mental health history and your experience of friendships and relationships (up 2.5 hours).
* You will be asked to complete a short, anonymised questionnaires about your experience of trauma and stress in your childhood including the Childhood Trauma Questionnaire and the Adverse Childhood Experiences questionnaire (15 minutes).
* You will complete a short emotional memory game (on the researchers' laptop or via your computer if via Zoom) (5 minutes).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: