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

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.

Study Overview

• Status: Recruiting
• Conditions: Preterm Birth; Psychological Distress; Mental Health; Cognitive Functioning
• Intervention / Treatment: Diagnostic test: Diagnostic procedures

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).

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Katharina Szota, PhD; Phone Number: +49 6421 2827115; Email: szota@uni-marburg.de
• Study Contact Backup: Name: Susan Schwarz, PhD; Phone Number: +49 6979 825326; Email: s.schwarz@zpt-gu.de

Study Locations

• Germany
  • Hesse
    • Frankfurt, Hesse, Germany, 60486
      • Recruiting
      • Johann Wolfgang Goethe University
      • Contact: Susan Schwarz, PhD; Phone Number: +49 (0)69 798 25326; Email: s.schwarz@zpt-gu.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Risk group; Risk for preterm birth, but no actual preterm birth	Diagnostic test: Diagnostic procedures; Self- and parent-report on behavioral/emotional symptoms and assessment of cognitive functioning
Preterm birth group; Risk for preterm birth and actual preterm birth	Diagnostic test: Diagnostic procedures; Self- and parent-report on behavioral/emotional symptoms and assessment of cognitive functioning
Control group; Term birth without risk for preterm birth	Diagnostic test: Diagnostic procedures; Self- and parent-report on behavioral/emotional symptoms and assessment of cognitive functioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's cognitive competencies	Wechsler Intelligence Scale for Children (WISC-V): Composite score on a IQ standard scores. Higher scores indicate a higher overall intellectual ability.	Single assessment in Autumn/Winter 2024

Collaborators and Investigators

• Sponsor: Goethe University
• Collaborators: Johann Wolfgang Goethe University Hospital
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 20, 2024

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: Preterm-Birth & Mental Health

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No