Clinical trial NCT06627140: Expected and Actual Preterm-Birth and Parental Distress: Impact on Children's Mental Health
Official title: Influence of Expected and Actual Preterm-Birth and Parental Distress on Children's Mental Health 6-11 Years Postpartum
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preterm Birth
Psychological Distress
Mental Health
Cognitive Functioning
Lead sponsor: Goethe University
Sponsor class: OTHER
Collaborators: name: Johann Wolfgang Goethe University Hospital
First posted: 2024-10-04
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and their parents will be included that participated in the previous study (see above). The study included pregnant women either with risk of preterm birth and term or actual preterm birth from the obstetric ward or a control group without risk from the antenatal class of the obstetric department and their partners.

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 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.

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 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\&#39;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).

Eligibility criteria: 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

Primary outcomes:
measure: Children's mental health
timeFrame: Single assessment in Summer/Autumn 2024
Secondary outcomes:
measure: Children's cognitive competencies
timeFrame: Single assessment in Autumn/Winter 2024
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Johann Wolfgang Goethe University
state: Hesse
Study officials:
affiliation: Johann Wolfgang Goethe University, Philipps-University Marburg
name: Katharina Szota, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Goethe University
name: Susan Schwarz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johann Wolfgang Goethe University Hospital
name: Silvia Oddo-Sommerfeld, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johann Wolfgang Goethe University Hospital
name: Frank Louwen, Prof
role: PRINCIPAL_INVESTIGATOR
References: