Influence of Expected and Actual Preterm-Birth and Parental Distress on Children's Mental Health 6-11 Years Postpartum
| Registry | NCT06627140 |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 250 (Estimated) |
| Sponsor | Goethe University (Other); collaborators: Johann Wolfgang Goethe University Hospital |
| Conditions | Preterm Birth, Psychological Distress, Mental Health, Cognitive Functioning |
| Interventions | Diagnostic procedures (Diagnostic test) |
| Dates | start 2024-07-08, primary completion 2024-10-31 (estimated), completion 2024-12-20 (estimated), first posted 2024-10-04, last updated 2024-10-04 |
| Locations | 1 site in Germany |
Related Papers Related Patents Related Grants Related Experts
All trials for Preterm Birth All trials for Psychological Distress All trials of Diagnostic procedures
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 children's' 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, e.g., threat and/or 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 children's mental health will be taken into consideration.
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 children's mental health. The investigators use the following questionnaires to assess children's mental health: Child Behaviour Checklist 6-18R (CBCL 6-18R), Conners 3rd Edition, Social Communication Questionnaire (SCQ), Revised Children\'s Anxiety and Depression Scale (RCADS). In addition, the investigators conduct clinical interviews with parents on their children's mental health and assess children's 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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Risk group | Diagnostic Test: Diagnostic procedures | Risk for preterm birth, but no actual preterm birth | |
| Preterm birth group | Diagnostic Test: Diagnostic procedures | Risk for preterm birth and actual preterm birth | |
| Control group | Diagnostic Test: Diagnostic procedures | Term birth without risk for preterm birth |
Sex: All, accepts healthy volunteers
Children and their parents must have participated in the previous study. Inclusion criteria of the previous study regarding the parents were: * Pregnant women and their partners from the 24th week of gestation on * 18 years of age Exclusion criteria of the previous study were: * Psychiatric, mainly psychotic diseases * Drug abuse * Severe neurological disorders * Stillbirth
| Facility | City | Country | Status |
|---|---|---|---|
| Johann Wolfgang Goethe University | Frankfurt am Main, Hesse | Germany | Recruiting |