Trials / Recruiting
RecruitingNCT03812913
Neuropsychological Assessment of Children and Adolescents With Turner Syndrome
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 70 (estimated)
- Sponsor
- University Hospital, Angers · Other Government
- Sex
- Female
- Age
- 7 Years – 16 Years
- Healthy volunteers
- Not accepted
Summary
Turner syndrome (TS) is a rare chromosomal disorder characterized by partial or complete loss of one of the X chromosomes that affects about one in every 2000 female babies born. These young patients described difficulties making friends, understanding others' emotions and intentions, and controlling their own emotions. Difficulties in these domains could led to social withdrawal, to reduced social skills and could have a significant impact on self esteem and mental health as well as on long-term academic and social functioning in affected individuals. The purpose of this project is to identify functional and dysfunctional cognitive and socio-cognitive abilities in these young patients which could account social difficulties described by some of them and their family. To this end, 35 girls with TS and 35 girls with isolated growth hormone deficiency and normal cerebral MRI will be recruited. Subjects will be 7 to 16 years and 11 months of age. Socio-cognitive and cognitive functions will be assessed with neuropsychological and experimental tasks. Questionnaires completed by patient, parents or teacher, will evaluate social and behavioral functioning.
Detailed description
Cross-sectional study (2 groups : Turner syndrome, isolated growth hormone deficiency), not randomized, controlled, associating several specialized centers in endocrine diseases. The pediatric endocrinologist of the participating centers will contact parents of each patient or voluntary child/adolescent in order to inform them of the study. The visit of inclusion will take place in the participant center during a routine monitoring visit. The first visit (V1) will take place immediately after the visit of inclusion in order to avoid a specific displacement for the needs for the study. The second visit (V2) will take place in participant's home. Each visit (V1 and V2) will last half-day. The period between V1 and V2 will be three months maximum. The visits V1 and V2 will be carried out by neuropsychologists of the Laboratoire de Psychologie des Pays de la Loire (LPPL - EA 4638).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | psychological evaluation | * Neuropsychological and experimental tasks will assess cognitive and socio-cognitive functions. * Questionnaires will assess psychoaffective aspects (depression, anxiety, self-esteem), and social and behavioral functioning. |
Timeline
- Start date
- 2019-09-05
- Primary completion
- 2025-12-05
- Completion
- 2025-12-05
- First posted
- 2019-01-23
- Last updated
- 2024-12-30
Locations
3 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03812913. Inclusion in this directory is not an endorsement.