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

NCT06627140 | Recruiting

• 1 other identifier: Preterm-Birth & Mental Health
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth; Psychological Distress; Mental Health; Cognitive Functioning

Outcome Measures

Primary Outcomes (1)

• Children's mental health

  Child 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.

  Single assessment in Summer/Autumn 2024

Secondary Outcomes (1)

• Children's cognitive competencies

  Single assessment in Autumn/Winter 2024

Study Arms (3)

Risk group

Risk for preterm birth, but no actual preterm birth

Diagnostic Test: Diagnostic procedures

Preterm birth group

Risk for preterm birth and actual preterm birth

Diagnostic Test: Diagnostic procedures

Control group

Term birth without risk for preterm birth

Diagnostic Test: Diagnostic procedures

Interventions

Diagnostic procedures DIAGNOSTIC_TEST

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

Control group; Preterm birth group; Risk group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Pregnant women and their partners from the 24th week of gestation on
• years of age

You may not qualify if:

• Psychiatric, mainly psychotic diseases
• Drug abuse
• Severe neurological disorders
• Stillbirth

Sponsors & Collaborators

• Goethe University: lead
• Johann Wolfgang Goethe University Hospital: collaborator

Study Sites (1)

Johann Wolfgang Goethe University

Frankfurt am Main, Hesse, 60486, Germany

RECRUITING

MeSH Terms

Conditions

Premature Birth; Psychological Well-Being

Interventions

Diagnostic Techniques and Procedures

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Diagnosis

Study Officials

• Katharina Szota, PhD

  Johann Wolfgang Goethe University, Philipps-University Marburg

  PRINCIPAL INVESTIGATOR

• Susan Schwarz, PhD

  Goethe University

  PRINCIPAL INVESTIGATOR

• Silvia Oddo-Sommerfeld, PhD

  Johann Wolfgang Goethe University Hospital

  PRINCIPAL INVESTIGATOR

• Frank Louwen, Prof

  Johann Wolfgang Goethe University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katharina Szota, PhD

CONTACT

+49 6421 2827115; szota@uni-marburg.de

Susan Schwarz, PhD

CONTACT

+49 6979 825326; s.schwarz@zpt-gu.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 4, 2024
• Study Start: July 8, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 20, 2024
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)