Growing up with X and Y chromosome trisomy: the TRIXY study

Growing up with X and Y chromosome trisomy: the TRIXY study - Sex Chromosome Trisomies (SCT)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45700

Enrollment

250

Registered

2016-11-08

Start date

2017-05-29

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Klinefelter syndrome Trisomy X

Interventions

Psychosocial intervention will include parent mediated intervention tools targeted at stimulating social-emotional development. Assignment is semi-random.

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: All children: - Signed informed parental consent - Dutch or English speaking - Age between 1 and 6 years;SCT group: - XXY, XYY or XXX chromosomal pattern (non-mosaic) based on standard karyotyping (parents will be asked to present a copy of the karyotyping report from the clinical genetics department)

Exclusion criteria

Exclusion criteria: All children: - History of closed-head injury or neurological illness;Control group: - CBCL (Childhood Behavior Checklist) score in clinical range

Design outcomes

Primary

Measure	Time frame
Study parameters include: - eyetracking (fixation duration, first fixations) - heart-rate and skin conductance measures (% change in beats per minute, heart rate variability, and skin conductance level) - (neuro)psychological test scores (accuracy, reaction times) - Questionnaires (sumscores) - Behavior observations (video recorded) (sumscores) - Structured parental interviews (sumscores)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)