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RecruitingNCT06823492Updated Feb 12, 2025

Investigating the Impacts of Early Life Experience on the Brain & Behaviour

An observational study in Mental Health, Neurodevelopment and ADHD, sponsored by University of Manchester. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-12.

Primary conditionAttention Deficit Disorder with HyperactivityRegistry: Psychological Well-BeingReclassifiedWhy we changed it
Registry
Psychological Well-Being — the first condition term the registry derived for this study.
ClinicalTrials.gg
Attention Deficit Disorder with Hyperactivity
Why
  1. Psychological Well-Being is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Attention Deficit Disorder with Hyperactivity.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Manchester · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Apr 2023; still recruiting 3 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
120
Ages
18 Years to 25 Years
Sex
All
01

Study 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.

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).
02

Conditions studied

  • Mental Health
  • Neurodevelopment
  • ADHD
  • Autism
  • Depression - Major Depressive Disorder
  • Anxiety Disorder (Panic Disorder or GAD)

Keywords

  • fMRI
  • cognition
  • brain imaging
  • adoption
  • trauma
03

In context

Attention Deficit Disorder with Hyperactivity Reclassified

1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.

This study's planned enrollment of 120 is close to the median of 127 across 329 observational studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

University of Manchester is the lead sponsor of 201 studies on the registry; 44 are open to participants now.

Browse University of Manchester studies →

Compared within Attention Deficit Disorder with Hyperactivity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Psychological Well-Being. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Control Group (Non-Adopted)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)
  • 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:

    1. I am not currently in education employment or training, or I am unemployed.
    2. I receive benefits from the Government e.g., housing benefits, universal credit, personal independent payment (PIP), disability benefit, job seekers allowance.
    3. I am currently struggling due mental health problems or neurodiversity (e.g., depression, anxiety, ADHD, autism, eating disorder)

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: January 2027

  2. 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)

    Time frame: March 2027

  3. 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.

    Time frame: March 2027

Secondary outcomes

  1. 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)

    Time frame: March 2027

  2. 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)

    Time frame: March 2027

07

Study locations

1 of 1 sites recruiting
  • Faculty of Biology Medicine & Health, University of Manchester
    Manchester, M13 9SS, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2023 (actual). Primary completion is estimated for Dec 2025, 32 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 10, 2024
First posted
Feb 12, 2025
StartActual
Apr 1, 2023
Primary completionEst.
Dec 30, 2025
CompletionEst.
Dec 30, 2027
Last update
Feb 12, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06823492
Lead sponsor
University of Manchester
Responsible party
Rebecca Elliot (Prof Chair in Affective Neuroscience, University of Manchester) — Principal investigator
First posted
Feb 12, 2025
Start date
Apr 1, 2023
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Feb 12, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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