Preterm BirthNCT06627140
Expected and Actual Preterm-Birth and Parental Distress: Impact on Children's Mental Health
An observational study of Preterm Birth and Psychological Distress, run by Goethe University at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Psychological Distress, Mental Health
- What is being tested?
- Diagnostic procedures
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 8 Jul 2024to 20 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study 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.
Who may be able to join
None listed.
Who cannot join
- Psychiatric, mainly psychotic diseases
- Drug abuse
- Severe neurological disorders
- Stillbirth
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Johann Wolfgang Goethe University
Frankfurt am Main, Hesse, 60486
Susan Schwarz, PhD, +49 (0)69 798 25326, s.schwarz@zpt-gu.de
About this study
Official title: Influence of Expected and Actual Preterm-Birth and Parental Distress on Children's Mental Health 6-11 Years Postpartum
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.
Read the 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).
- Being tested
- Diagnostic procedures
- Medical subject headings
- Premature Birth, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic proceduresDiagnostic test
Self- and parent-report on behavioral/emotional symptoms and assessment of cognitive functioning
| Study group | Role | What they receive |
|---|---|---|
| Risk group | Risk for preterm birth, but no actual preterm birth Receives: Diagnostic Test: Diagnostic procedures | |
| Preterm birth group | Risk for preterm birth and actual preterm birth Receives: Diagnostic Test: Diagnostic procedures | |
| Control group | Term birth without risk for preterm birth Receives: Diagnostic Test: Diagnostic procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single assessment in Summer/Autumn 2024
Secondary 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.
Measured: Single assessment in Autumn/Winter 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start8 Jul 2024
- Primary completion31 Oct 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Collaborators
- Johann Wolfgang Goethe University Hospital
- Responsible party
- Principal investigator, Katharina Szota, Dr., Goethe University
- Investigators
- Katharina Szota, PhD, Principal investigator, Johann Wolfgang Goethe University, Philipps-University MarburgSusan Schwarz, PhD, Principal investigator, Goethe UniversitySilvia Oddo-Sommerfeld, PhD, Principal investigator, Johann Wolfgang Goethe University HospitalFrank Louwen, Prof, Principal investigator, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627140
- Sponsor's protocol ID
- Preterm-Birth & Mental Health
- Status last verified
- Oct 2024
- First submitted
- 27 Sep 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Expected and Actual Preterm-Birth and Parental Distress on Children's Mental Health 6-11 Years Postpartum
- ClinicalTrials.gov ID
- NCT06627140
- Acronym / sponsor ID
- Preterm-Birth & Mental Health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Collaborators
- Johann Wolfgang Goethe University Hospital
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Risk group | – | Diagnostic Test: Diagnostic proceduresRisk for preterm birth, but no actual preterm birth |
| Preterm birth group | – | Diagnostic Test: Diagnostic proceduresRisk for preterm birth and actual preterm birth |
| Control group | – | Diagnostic Test: Diagnostic proceduresTerm birth without risk for preterm birth |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Psychiatric, mainly psychotic diseases
- Drug abuse
- Severe neurological disorders
- Stillbirth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic proceduresSelf- and parent-report on behavioral/emotional symptoms and assessment of cognitive functioning | Diagnostic test | Control group, Preterm birth group, Risk group |
Primary outcome
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.
1 secondary outcome
Children's cognitive competencies
Time frame: Single assessment in Autumn/Winter 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katharina Szota, PhD principal investigator
Johann Wolfgang Goethe University, Philipps-University Marburg
Susan Schwarz, PhD principal investigator
Goethe University
Silvia Oddo-Sommerfeld, PhD principal investigator
Johann Wolfgang Goethe University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth and Psychological Distress, run by Goethe University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katharina Szota, PhD (+49 6421 2827115, szota@uni-marburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's mental health (time frame: Single assessment in Summer/Autumn 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.