Pro_Mini Study: Regulation Problems in Mother-Child-Dyads in the Context of Prenatal Risks: Combining novel assessment strategies and Biomarkers to Develop Clinical Intervention Tools

Pro_Mini Study: Regulation Problems in Mother-Child-Dyads in the Context of Prenatal Risks: Combining novel assessment strategies and Biomarkers to Develop Clinical Intervention Tools - Pro_Mini

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00034127

Enrollment

208

Registered

2024-07-19

Start date

2025-01-01

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

Regulatory Disorders in early childhood

Interventions

Group 1: intervention group: participation in 12-week Pro_Mini mother-child group intervention (12 weekly group sessions of 90 minutes each plus 2 individual sessions [a 60-minute preliminary consulta

participation in a 60-minute preliminary consultation including anamnesis

Eligibility

Sex/Gender

All

Age

0 Years to 5 Years

Inclusion criteria

Inclusion criteria: Infants and toddlers with regulatory problems and their mothers

Exclusion criteria

Exclusion criteria: - non-biological mother-child-dyads like foster or adoptive families - mother: acute suicidality; acute psychotic symptoms; acute influence of substances; problems in understanding study content or questionnaires - child: neurological and/ or genetic disorders

Design outcomes

Primary

Measure	Time frame
Improvement in early childhood self-regulation (regulatory abilities [IBQ-R-VSF/ ECBQ-VSF/ CBQ-VSF], regulation problems [BITSEA/ CBCL 1,5-5], regulatory disorders [SIVA 0-6]) through participation in the Pro_Mini group intervention (intervention group) compared to the waiting control group	—

Secondary

Measure	Time frame
- Improvement of mother-child-interaction (behavioral observation of maternal sensitivity), of mother-child-attachment (ARI-CP 2-5), and maternal mental health (BSI, PSS-10) through participation in the Pro_Mini group intervention (intervention group) compared to the waiting control group - Changes in biological stress markers (cortisol, DNA methylation) due to participation in the Pro_Mini group intervention compared to a waiting control group - Responder vs. non-responder analyses based on prenatal risk exposure (retrospective, self-developed and validated prenatal risk index) and biological stress markers (cortisol, DNA methylation)	—

Measure

Time frame

- Improvement of mother-child-interaction (behavioral observation of maternal sensitivity), of mother-child-attachment (ARI-CP 2-5), and maternal mental health (BSI, PSS-10) through participation in the Pro_Mini group intervention (intervention group) compared to the waiting control group - Changes in biological stress markers (cortisol, DNA methylation) due to participation in the Pro_Mini group intervention compared to a waiting control group - Responder vs. non-responder analyses based on prenatal risk exposure (retrospective, self-developed and validated prenatal risk index) and biological stress markers (cortisol, DNA methylation)

—

Countries

Germany

Contacts

Public ContactAnna Eichler

Kinder- und Jugendabteilung für Psychische Gesundheit, Universitätsklinikum Erlangen

anna.eichler@uk-erlangen.de+49 9131 85 39123

Outcome results

None listed

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