NCT05153109

Brief Summary

The Kleinkind-DIPS (Diagnostisches Interview bei psychischen Störungen für Kleinkinder) is a structured interview to assess a variety of the most frequent psychological problems in babies and preschoolers, e.g. feeding or sleeping problems, anxiety disorders. It is administered by a trained clinician with one of the primary carers. In this study, its acceptance, reliability and validity will be tested in a clinical and non-clinical sample.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2020

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 29, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2023

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

November 29, 2021

Last Update Submit

May 23, 2025

Conditions

Keywords

clinical interview

Outcome Measures

Primary Outcomes (1)

  • Kleinkind-DIPS

    structured interview for parents of preschoolers

    within one week of the other measures

Secondary Outcomes (4)

  • Fragebogen zum Schreien, Füttern, Schlafen (SFS)

    within one week of the other measures; only for parents of children aged 18 months or younger

  • Depression Anxiety Stress Scale (DASS-21)

    within one week of the other measures;

  • Strengths and Difficulties Questionnaire (SDQ)

    within one week of the other measures; only for parents of children aged 18 months or older

  • Parental sense of control (PSCO)

    within one week of the other measures;

Other Outcomes (1)

  • Acceptance of the Interview

    within one week after being interviewed

Study Arms (2)

Community sample

Participants will be recruited from families in Bochum who take part in experiments and studies at the department of delevopmental psychology at the Ruhr-University. The department of developmental psychology organizes a panel every year inviting all parents of newborn babies in Bochum to register if they want to participate in research.

Clinical sample

Participants will be recruited from families in Bochum and Munich who seek treatment in the outpatient treatment centers at both sites. Both study sites offer special counselling for parents who experience difficulties with a child from zero to five years of age.

Eligibility Criteria

Age0 Months - 71 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

All parents who have a child in the according age group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ludwig Maximilian University of Munich

Munich, Bavaria, 80802, Germany

Location

Ruhr-University

Bochum, North Rhine-Westphalia, 44801, Germany

Location

Study Officials

  • Silvia Schneider, Phd

    Ruhr University of Bochum

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Invertigator

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 10, 2021

Study Start

November 15, 2020

Primary Completion

November 27, 2023

Study Completion

November 27, 2023

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

we cannot share individual participant data due to data protection constrictions

Locations