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Reducing stress, alcohol and tobacco use in pregnant women to improve the children’s later mental health

Reducing stress, alcohol and tobacco use in pregnant women to improve the children’s later mental health - MINDFUL/PMI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00014920
Enrollment
312
Registered
2018-10-08
Start date
2020-02-13
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant markers for mental health, self-regulation, developmental status, and behavioral problems Pregnancy

Interventions

Group 1: Pregnancy mindfulness: 15-week mindfulness-oriented app-based program Group 2: Pregnancy education: 15-week pregnancy education app-based program

Sponsors

Universitätsklinikum Erlangen
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: • pregnant women between 8+0 to 14+0 weeks of pregnancy • pregnant women who have signed the informed consent • pregnant women who agree to take part in the examinations (blood, urine, second-to-fourth finger length ratio [2D:4D], heart rate variability, questionnaires, examination of the child, etc.) • pregnant women who agree to use the app • pregnant women with an unproblematic pregnancy at the time of inclusion

Exclusion criteria

Exclusion criteria: • multiple pregnancy • manifest comprehension problems during the introductory briefing • prior severe psychiatric illness • past history of adverse or missing effects of mindfulness exercises

Design outcomes

Primary

MeasureTime frame
Second-to-fourth finger length ratio (2D:4D) in the 11- to 12-month-old child

Secondary

MeasureTime frame
Child (birth and 11- to 12-month of age): Index “Orientation and Regulation“ of the Infant Behavior Questionnaire Revised (IBQ-R); subscale scores of the German Parent Questionnaire of Child Development supplement to the Pediatric Screenings (EEE U6); subscale scores cognition, language, and motor function of the Bayley Scales of Infant and Toddler Development (BSID); sum and subscale scores of the Child Behavior Checklist (CBCL); infant anogenital distance; strength of the transient-evoked otoacoustic emissions (TEOAEs); ethylglucuronide (EtG) in meconium. Mother (longitudinal): Sum and subscale scores of the Perceived Stress Scale (PSS10); sum scale score of the Pregnancy Related Anxiety Questionnaire (PRAQ-R2); sum and subscale scores of the Mindful Attention and Awareness Scale (MAAS) and the Five Facet-Mindfulness Questionnaire (FFMQ-D); consumption quantified by the modified Alcohol Use Disorder Identification Test (AUDIT-C); consumption quantified by the modified smoking questionnaire Robert Koch-Institut; cotinine in maternal hair; ethylglucuronide (EtG) in maternal hair; cortisol in maternal hair.

Countries

Germany

Contacts

Public ContactJohannes Kornhuber

Universitätsklinikum Erlangen, Psychiatrische und Psychotherapeutische Klinik

johannes.kornhuber@uk-erlangen.de+49 9131 85 34166

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026