Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627140
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
Expected and Actual Preterm-Birth and Parental Distress Impact on Childrens Mental Health
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Influence of Expected and Actual Preterm-Birth and Parental Distress on Childrens Mental Health 6-11 Years Postpartum
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the present study is the assessment of the mental health and cognitive development of children 6-11 years after premature or term birth Impairments in childrens mental health are assessed focusing different disorders or problems ADHD Autism traits Affective disorders oppositional-aggressive behavior and using both questionnaires and a clinical interview Risk and protective factors will be analyzed eg threat andor actual premature birth compared to term birth parents mental health positive coping personality traits and social support in the peripartum period and afterwards as well as medical parameters The potential interaction of premature birth medical complications parental distress and childrens mental health will be taken into consideration
Detailed Description:
A follow-up survey is conducted based on a previous study on psychological distress in parents with preterm infants NCT01974531 Medical records and previous questionnaire data will be used for grouping the children based on threat of preterm birth actual preterm birth and term birth as well as to assess the risk and protective factors in the peripartum period
Parents have been informed within the first study part that a second study part including their children would have been followed Parents were recontacted and asked for participation via telephone or email Those who agreed will be contacted via questionnaires in a first step and then in a second step interviewed regarding their own and their childrens mental health The investigators use the following questionnaires to assess childrens mental health Child Behaviour Checklist 6-18R CBCL 6-18R Conners 3rd Edition Social Communication Questionnaire SCQ Revised Children39s Anxiety and Depression Scale RCADS In addition the investigators conduct clinical interviews with parents on their childrens mental health and assess childrens cognitive competencies using the Wechsler Intelligence Scale for Children WISC-V The following questionnaires are used to assess parental risk and protective factors State-Trait Anxiety-Depression Inventory STADI Parental Stress Scale PSS Parenting Scale Short Form PS Big Five Inventory Short Form BFI
Parents have been informed within the first study part that a second study part including their children would have been followed Parents were recontacted and asked for participation via telephone or email Those who agreed will be contacted via questionnaires in a first step and then in a second step interviewed regarding their own and their childrens mental health The investigators use the following questionnaires to assess childrens mental health Child Behaviour Checklist 6-18R CBCL 6-18R Conners 3rd Edition Social Communication Questionnaire SCQ Revised Children39s Anxiety and Depression Scale RCADS In addition the investigators conduct clinical interviews with parents on their childrens mental health and assess childrens cognitive competencies using the Wechsler Intelligence Scale for Children WISC-V The following questionnaires are used to assess parental risk and protective factors State-Trait Anxiety-Depression Inventory STADI Parental Stress Scale PSS Parenting Scale Short Form PS Big Five Inventory Short Form BFI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None