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Идёт набор NCT06627140

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

— Наблюдательное Preterm Birth Psychological Distress Mental Health Cognitive Functioning

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Diagnostic procedures.
Кому может быть актуально
Состояния в реестре: Preterm Birth, Psychological Distress, Mental Health, Cognitive Functioning. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Германия
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

  • Диагностический тест Diagnostic procedures
    Self- and parent-report on behavioral/emotional symptoms and assessment of cognitive functioning

Первичные конечные точки

  • Children's mental health [Срок оценки: Single assessment in Summer/Autumn 2024]
Вторичные конечные точки (1)
  • Children's cognitive competencies [Срок оценки: Single assessment in Autumn/Winter 2024]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Германия · 1 центр
  • Johann Wolfgang Goethe University — Frankfurt am Main

Идентификаторы

NCT: NCT06627140 · Preterm-Birth & Mental Health

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗