Actively Recruiting
Influence of Expected and Actual Preterm-Birth and Parental Distress on Children's Mental Health 6-11 Years Postpartum
Led by Goethe University · Updated on 2024-10-04
250
Participants Needed
1
Research Sites
7 weeks
Total Duration
On this page
Sponsors
G
Goethe University
Lead Sponsor
J
Johann Wolfgang Goethe University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the mental health and cognitive development of children aged 6 to 11 years who were born prematurely or at term. This study focuses on assessing various mental health challenges, including ADHD, autism traits, affective disorders, and oppositional-aggressive behavior. It also looks at risk and protective factors such as the experience of premature birth, parental mental health, coping strategies, personality traits, social support, and medical complications. The study involves grouping children based on whether they were at risk for preterm birth without actual preterm birth, had an actual preterm birth, or were born at term without risk. Data from medical records and previous questionnaires are used for this grouping. Parents and children participate by completing questionnaires and clinical interviews to assess mental health and cognitive abilities. Questionnaires used include the Child Behaviour Checklist, Conners 3rd Edition, Social Communication Questionnaire, and anxiety and depression scales, while cognitive function is tested with the Wechsler Intelligence Scale for Children. Participants are recontacted and asked to complete questionnaires and interviews about parental and child mental health. Researchers collect information through self- and parent-reports on behavioral and emotional symptoms and cognitive testing. The main outcome measured is children's mental health assessed in Summer/Autumn 2024, with cognitive competencies evaluated in Autumn/Winter 2024. The study also examines parental risk and protective factors using validated questionnaires. This observational study is conducted by Goethe University and includes families who participated in a prior related study.
CONDITIONS
Brief Title
Expected and Actual Preterm-Birth and Parental Distress: Impact on Children's Mental Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and their parents participated in the previous related study
- Pregnant women and their partners were enrolled from the 24th week of gestation or later
- Parents were at least 18 years old at the time of the previous study
You will not qualify if you...
- Psychiatric disorders mainly psychotic in nature
- History of drug abuse
- Severe neurological disorders
- Stillbirth in the previous pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Contact via telephone or email for participation consent
Duration - Single assessment period in Summer to Winter 2024
Participants complete questionnaires and clinical interviews to assess children's mental health and cognitive competencies, as well as parental risk and protective factors.
Questionnaires and interviews conducted remotely and in-person assessments during 1 to 2 visits
Trial Site Locations
Total: 1 location
1
Johann Wolfgang Goethe University
Frankfurt am Main, Hesse, Germany, 60486
Actively Recruiting
Research Team
K
Katharina Szota, PhD
S
Susan Schwarz, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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