Reliabilty and Validity of a Diagnostic Interview for Parents of Babies and Preescholers

May 23, 2025 updated by: Ruth von Brachel, Ruhr University of Bochum

Reliabilty and Validity of a Diagnostic Interview for Parents of Babies and Preschoolers

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The Kleinkind- DIPS (Diagnostisches Interview bei psychischen Störungen für Kleinkinder) is a structured interview to assess a variety of the most frequent psychological 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. Parts of the interview are adapted from the Kinder-DIPS, for which information on acceptance, reliability and validity are available. The aim of the present study is to test the interviews acceptance, reliability and validity in both a clinical and a non-clinical sample.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 80802
        • Ludwig Maximilian University of Munich
    • North-Rhine Westphalia
      • Bochum, North-Rhine Westphalia, Germany, 44801
        • Ruhr-University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second to 5 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria: sufficient knowledge of the German language -

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Family-Based
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Kleinkind-DIPS
Time Frame: within one week of the other measures
structured interview for parents of preschoolers
within one week of the other measures

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fragebogen zum Schreien, Füttern, Schlafen (SFS)
Time Frame: within one week of the other measures; only for parents of children aged 18 months or younger
Questionnaire assessing feeding, sleeping and crying in young infants, three subscales: feeding problems, sleep problems, coregulation; scores (means) ranging from 1-4, higher scores indicate more problems
within one week of the other measures; only for parents of children aged 18 months or younger
Depression Anxiety Stress Scale (DASS-21)
Time Frame: within one week of the other measures;
Questionnaire assessing depression, anxiety and stress of the parents, higher scores indicate higher stress or psychopathology; depression scores range from 0-28; stress scores 0-34, anxiety 0-20;
within one week of the other measures;
Strengths and Difficulties Questionnaire (SDQ)
Time Frame: within one week of the other measures; only for parents of children aged 18 months or older
Questionnaire assessing internalizing and externalizing problems in children; 5 sub scales of which 4 capture problems (e.g. emotional difficulties, conduct problems) and one scale which captures prosocial behaviour; For each of the 5 scales the score can range from 0 to 10 with higher scores indicating more problems and more prosocial behaviour
within one week of the other measures; only for parents of children aged 18 months or older
Parental sense of control (PSCO)
Time Frame: within one week of the other measures;
Questionnaire assessing self-efficacy and sense of control of the parents; Two subsacles: efficacy and satisfaction; means between 1-6. A higher score indicates a higher parenting sense of competency.
within one week of the other measures;

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acceptance of the Interview
Time Frame: within one week after being interviewed
Questionnaire assessing parents perception of the interview, 10 Items assessing 5 positive and 5 negative attitudes towards the interview, higher scores indicate higher endorsement. One additional item assessing global satisfaction with the interview on a scale from 0-100, higher scores indicate higher satisfaction.
within one week after being interviewed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruhr University of Bochum

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ludwig-Maximilians - University of Munich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Silvia Schneider, Phd, Ruhr University of Bochum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 27, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 553

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

we cannot share individual participant data due to data protection constrictions

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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