Expected and Actual Preterm-Birth and Parental Distress: Impact on Children's Mental Health
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorGoethe University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant women and their partners from the 24th week of gestation on
18 years of age
Disqualifiers
Psychiatric, mainly psychotic diseases
Drug abuse
Severe neurological disorders
Stillbirth
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Diagnostic procedures
Diagnostic testSelf- and parent-report on behavioral/emotional symptoms and assessment of cognitive functioning
Treatment groups
250 Participants
are divided into 3 treatment groupsGroup A: Risk group1 intervention
Group B: Preterm birth group1 intervention
Group C: Control group1 intervention
Trial outcomes
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.
Time frame
Single assessment in Summer/Autumn 2024Secondary outcomes
1
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.
Time frame
Single assessment in Autumn/Winter 2024Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Goethe University
Lead sponsor
Johann Wolfgang Goethe University Hospital
Collaborator
Source ClinicalTrials.gov