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Expected and Actual Preterm-Birth and Parental Distress: Impact on Children's Mental Health

Influence of Expected and Actual Preterm-Birth and Parental Distress on Children's Mental Health 6-11 Years Postpartum

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06627140
Enrollment
250
Registered
2024-10-04
Start date
2024-07-08
Completion date
2024-12-20
Last updated
2024-10-04

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

Conditions

Preterm Birth, Psychological Distress, Mental Health, Cognitive Functioning

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'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).

Interventions

DIAGNOSTIC_TESTDiagnostic procedures

Self- and parent-report on behavioral/emotional symptoms and assessment of cognitive functioning

Sponsors

Johann Wolfgang Goethe University Hospital
CollaboratorOTHER
Goethe University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Children's mental healthSingle assessment in Summer/Autumn 2024Child Behaviour Checklist 6-18R (CBCL 6-18R), eight problem scales: anxious/depressed (scores from 0 to 26), depressed (scores from 0 to 16), somatic complaints (scores from 0 to 22), social problems (scores from 0 to 22), thought problems (scores from 0 to 30), attention problems (scores from 0 to 20), rule-breaking behaviour (scores from 0 to 34), aggressive behaviour (scores from 0 to 36) with higher scores indicating more difficulties.

Secondary

MeasureTime frameDescription
Children's cognitive competenciesSingle assessment in Autumn/Winter 2024Wechsler Intelligence Scale for Children (WISC-V): Composite score on a IQ standard scores. Higher scores indicate a higher overall intellectual ability.

Countries

Germany

Contacts

Primary ContactKatharina Szota, PhD
szota@uni-marburg.de+49 6421 2827115
Backup ContactSusan Schwarz, PhD
s.schwarz@zpt-gu.de+49 6979 825326

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026