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NCT Number: NCT06627140

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Johann Wolfgang Goethe University

Frankfurt am Main, Hesse, 60486, Germany

Location status: Recruiting

Location contact

Susan Schwarz, PhD

CONTACT

[email protected]

+49 (0)69 798 25326

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic procedures

Diagnostic Test

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

Primary outcomes

  1. Children's mental health

    Time frame: Single assessment in Summer/Autumn 2024

    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.

Secondary outcomes

  1. Children's cognitive competencies

    Time frame: Single assessment in Autumn/Winter 2024

    Wechsler Intelligence Scale for Children (WISC-V): Composite score on a IQ standard scores. Higher scores indicate a higher overall intellectual ability.

Study contacts

Contact information is provided by the study sponsor or research team.

Katharina Szota, PhD

CONTACT

[email protected]

+49 6421 2827115

Susan Schwarz, PhD

CONTACT

[email protected]

+49 6979 825326

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Collaborators

  • Johann Wolfgang Goethe University Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 4, 2024
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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