Mental HealthNCT06823492
Investigating the Impacts of Early Life Experience on the Brain & Behaviour
An observational study of Mental Health and Neurodevelopment, run by University of Manchester at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Neurodevelopment, ADHD
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2023to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Control Group (Non-Adopted)
Who may be able to join
- Age 18-24
- Reside in Greater Manchester
- You are not enrolled on a university degree course and do not hold a university degree qualification
- Lived with one or both birth parents throughout childhood.
- Able to travel to the University of Manchester
- Able to understand the study information and participate in the assessment procedures described below (independently or with reading support from a researcher, friend or family member)
Show all 11Show fewer
- Able to read text on a computer screen (using glasses or contact lenses if required)
- To sign up for this study one or more of the following statements should apply to you:
- I am not currently in education employment or training, or I am unemployed.
- I receive benefits from the Government e.g., housing benefits, universal credit, personal independent payment (PIP), disability benefit, job seekers allowance.
- I am currently struggling due mental health problems or neurodiversity (e.g., depression, anxiety, ADHD, autism, eating disorder)
Who cannot join
- You were looked after by the local authority (e.g., foster, kinship care or residential children's home) or adopted during childhood.
- Any experience of childhood trauma (including neglect, physical/verbal abuse, sexual abuse or exposure to domestic violence).
- Your family required input from social services due to child protection concerns.
- You are experiencing symptoms of and have been diagnosed with Post-Traumatic Stress Disorder (PTSD), borderline personality disorder (BPD), Emotionally Unstable Personality Disorder (EUPD).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Faculty of Biology Medicine & Health, University of Manchester
Manchester, M13 9SS
Mica Komarnyckyj, MEng, MSc, PhD, +447341098802, Mica.komarnyckyj@manchester.ac.uk
Rebecca Elliott, PhD
About this study
Official title: Effects of Early Trauma on Neurocognitive Development and Mental Health
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.
Read the 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).
- Conditions
- Mental Health, Neurodevelopment, ADHD, Autism, Depression - Major Depressive Disorder, Anxiety Disorder (Panic Disorder or GAD)
- Keywords
- fMRI, cognition, brain imaging, adoption, trauma
- Medical subject headings
- Psychological Well-Being, Attention Deficit Disorder with Hyperactivity, Autistic Disorder, Anxiety Disorders, Panic Disorder, Generalized Anxiety Disorder, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Young adults, aged 18-15 who were not adopted and have no experience of childhood trauma | |
| Adopted Group | Young adults, aged 18-15 who were adopted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental health prevalence
Will be assessed on an individual subject level using the Structured Clinical Interview for DSM-V (SCID-5). (Outcome Measure: Summary counts of participants in each group showing the occurrence of different mental health disorders)
Measured: January 2027
Neurodevelopmental condition prevalence
Autism will be assessed using the online screening tool, Autism Spectrum Quotient (ASQ) and the Autism Diagnostic Observation Schedule (ADOS). (Outcome Measure: Summary counts of participants in each group showing the occurrence of different neurodevelopmental disorders)
Measured: March 2027
Neural Processing Differences related to childhood trauma and mental health: whole brain anlaysis
fMRI analyses will first be analysed using a typical univariate approach using Statistical Parametric Mapping. Exploratory whole brain analyses will be conducted. Statistical comparisons will be made between the adopted and control groups.
Outcome measure: BOLD signal change in brain regions identified during whole brain comparisons which are associated with specific conditions of interest/task contrasts, and how these differ between the groups.
Measured: March 2027
Secondary outcomes (2)
Employment
This data will be collected using self-report online questionnaires. (Outcome Measure: Summary counts of participants in each group showing the occurrence of different levels of employment)
Measured: March 2027
Education level
This data will be collected using self-report online questionnaires. (Outcome Measure: Summary counts of participants in each group showing the occurrence of different levels of education)
Measured: March 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Apr 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Elliot, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823492
- Sponsor's protocol ID
- 2024-17962-32800
- Status last verified
- Feb 2025
- First submitted
- 10 Dec 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Trauma on Neurocognitive Development and Mental Health
- ClinicalTrials.gov ID
- NCT06823492
- Acronym / sponsor ID
- 2024-17962-32800
- Conditions
- Mental Health, Neurodevelopment, ADHD, Autism, Depression - Major Depressive Disorder, Anxiety Disorder (Panic Disorder or GAD)
- Keywords
- fMRI, cognition, brain imaging, adoption, trauma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Young adults, aged 18-15 who were not adopted and have no experience of childhood trauma |
| Adopted Group | – | –Young adults, aged 18-15 who were adopted |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Control Group (Non-Adopted)
Key inclusion criteria (11 listed)
- Age 18-24
- Reside in Greater Manchester
- You are not enrolled on a university degree course and do not hold a university degree qualification
- Lived with one or both birth parents throughout childhood.
- Able to travel to the University of Manchester
Key exclusion criteria (4 listed)
- You were looked after by the local authority (e.g., foster, kinship care or residential children's home) or adopted during childhood.
- Any experience of childhood trauma (including neglect, physical/verbal abuse, sexual abuse or exposure to domestic violence).
- Your family required input from social services due to child protection concerns.
- You are experiencing symptoms of and have been diagnosed with Post-Traumatic Stress Disorder (PTSD), borderline personality disorder (BPD), Emotionally Unstable Personality Disorder (EUPD).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mental health prevalence
Time frame: January 2027
Will be assessed on an individual subject level using the Structured Clinical Interview for DSM-V (SCID-5). (Outcome Measure: Summary counts of participants in each group showing the occurrence of different mental health disorders)
Neurodevelopmental condition prevalence
Time frame: March 2027
Autism will be assessed using the online screening tool, Autism Spectrum Quotient (ASQ) and the Autism Diagnostic Observation Schedule (ADOS). (Outcome Measure: Summary counts of participants in each group showing the occurrence of different neurodevelopmental disorders)
Neural Processing Differences related to childhood trauma and mental health: whole brain anlaysis
Time frame: March 2027
fMRI analyses will first be analysed using a typical univariate approach using Statistical Parametric Mapping. Exploratory whole brain analyses will be conducted. Statistical comparisons will be made between the adopted and control groups. Outcome measure: BOLD signal change in brain regions identified during whole brain comparisons which are associated with specific conditions of interest/task contrasts, and how these differ between the groups.
2 secondary outcomes
Employment
Time frame: March 2027
Education level
Time frame: March 2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Mental Health
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Faculty of Biology Medicine & Health, University of Manchester
Manchester, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health and Neurodevelopment, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental health prevalence (time frame: January 2027). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.