NCT06823492

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Apr 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Apr 2023Dec 2027

Study Start

First participant enrolled

April 1, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Expected
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

2.8 years

First QC Date

December 10, 2024

Last Update Submit

February 6, 2025

Conditions

Keywords

fMRIcognitionbrain imagingadoptiontrauma

Outcome Measures

Primary Outcomes (3)

  • 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)

    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)

    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.

    March 2027

Secondary Outcomes (2)

  • Employment

    March 2027

  • Education level

    March 2027

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Control Group (Non-Adopted)

You may qualify if:

  • 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:
  • 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)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Biology Medicine & Health, University of Manchester

Manchester, M13 9SS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Psychological Well-BeingAttention Deficit Disorder with HyperactivityAutistic DisorderAnxiety DisordersPanic DisorderGeneralized Anxiety DisorderWounds and Injuries

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersAutism Spectrum DisorderChild Development Disorders, Pervasive

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Chair in Affective Neuroscience

Study Record Dates

First Submitted

December 10, 2024

First Posted

February 12, 2025

Study Start

April 1, 2023

Primary Completion

December 30, 2025

Study Completion (Estimated)

December 30, 2027

Last Updated

February 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations