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Locus-Coeruleus Norepinephrine functioning as a predictor of childhood mental health

Locus-Coeruleus Norepinephrine functioning as a predictor of childhood mental health - LOCUS-MENTAL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00035866
Enrollment
530
Registered
2025-01-23
Start date
2025-07-09
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F F00-F99

Interventions

Group 1: LOCUS-MENTAL will achieve its objectives by combining pupillometric indices of LC-NE functioning with a prospective panel design. Pupillometry is assessed by video-based eye tracking during b

Sponsors

Goethe Universität Frankfurt
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 8 Years

Inclusion criteria

Inclusion criteria: presented in outpatient clinic

Exclusion criteria

Exclusion criteria: genetic syndromes and neurological diseases

Design outcomes

Primary

MeasureTime frame
The primary outcome is the the prediction of transdiagnostic psychopathology at school age based on preschol LC-NE functioning. The sample are 300 preschool children that assessed at three timepoints. At each timepoint, we will apply the pupillometric battery (main measures: BPS, SEPR), the caregiver questionnaires (CBCL 4-18, SDQ), the clinical interview on symptoms (PAPA), and the multiple-sources assessment of childhood adversity. This includes the initial assessment (t1 = 4-6 years of age). Participants will be reassessed after one year (t2 = 5-7 years of age) and after two years (t3 = 6-8 years of age). This represents an accelerated longitudinal design, which allows to estimate an autoregressive cross-lagged panel model that will quantify the effect of previous LC-NE functioning (BPS, SEPR) on later transdiagnostic psychopathology factors (CBCL, SDQ) from four to eight years of age (see figure 6). Potential cohort effects (initial age: 4 vs. 5 vs. 6 years) will be considered by random intercepts for cohort. Each model fit will be evaluated by the predefined indices of CFI, TLI, RMSEA, and SRMR.

Secondary

MeasureTime frame
A secondary outcome is that LC-NE functioning corresponds to early dispositional risks for psychopathology. In 140 preschool children of concern, we will assess the pupillometric battery of LC-NE functioning and measures of irritability and behavioral inhibition. These temperament traits are measured by caregiver-reports with the Behavioral Inhibition Questionnaire (BIQ) (Bishop et al., 2003) and the Preschool Irritability Scale (PIS) of the Preschool Age Psychiatric Assessment (PAPA) (Dougherty et al., 2015). We further assess negative emotionality with the Child Behavior Questionnaire - Very Short Form (CBQ-VSF) (Putnam & Rothbart, 2006). The three transdiagnostic factors of psychopathology will be assessed with the Child Behavior Checklist (CBCL 4-18) and the Strength and Difficulties Questionnaire (SDQ) (Caci et al., 2015; Stanton et al., 2020). In a concurrent EEG, we will assess the ERP of error-related negativity (ERN) in an age-appropriate go/no-go task (Kessel et al., 2016). We will further assess neurocognitive paradigms of irritability with a dot-probe task (Salum et al., 2017) and a frustrative reward learning task (Deveney et al., 2013). Another secondary outcome is that LC-NE functioning mediates the association between childhood adversity and current symptoms of transdiagnostic psychopathology. The team will recruit 300 preschool children of concern (aged 4-6 years). Assessments include the pupillometry battery of LC-NE functioning and measures of the transdiagnostic psychopathology factors (externalizing, internalizing, and p-factor) that are assessed with the CBCL 4-18 and the SDQ (Caci et al., 2015; Stanton et al., 2020). The PAPA interview will validate symptom domains. In addition, we assess childhood adversity based on multiple sources. This includes a caregiver interview that captures adverse childhood experiences and other psychosocial domains (ACE+) (Finkelhor et al., 2013), a respective child interview (Finkelhor et al., 2015) a

Countries

Germany

Contacts

Public ContactDr. Bast

Goethe Universität Frankfurt

nbast@med.uni-frankfurt.de+496963016223

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026