Expected and Actual Preterm-Birth and Parental Distress: Impact on Children's Mental Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diagnostic procedures.
- Who it may be relevant to
- Registry conditions: Preterm Birth, Psychological Distress, Mental Health, Cognitive Functioning. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Influence of Expected and Actual Preterm-Birth and Parental Distress on Children's Mental Health 6-11 Years Postpartum
Overview
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 test Diagnostic procedures
Self- and parent-report on behavioral/emotional symptoms and assessment of cognitive functioning
Primary outcome measures
- Children's mental health [Time frame: Single assessment in Summer/Autumn 2024]
Secondary outcome measures (1)
- Children's cognitive competencies [Time frame: Single assessment in Autumn/Winter 2024]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Johann Wolfgang Goethe University — Frankfurt am Main
Identifiers
NCT: NCT06627140 · Preterm-Birth & Mental Health