- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05153109
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
Completed
Conditions
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
Observational
Enrollment (Actual)
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
-
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Bavaria
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Munich, Bavaria, Germany, 80802
- Ludwig Maximilian University of Munich
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North-Rhine Westphalia
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Bochum, North-Rhine Westphalia, Germany, 44801
- Ruhr-University
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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
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 |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kleinkind-DIPS
Time Frame: within one week of the other measures
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structured interview for parents of preschoolers
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within one week of the other measures
|
Secondary Outcome Measures
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
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within one week of the other measures; only for parents of children aged 18 months or younger
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Depression Anxiety Stress Scale (DASS-21)
Time Frame: within one week of the other measures;
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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;
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within one week of the other measures;
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Strengths and Difficulties Questionnaire (SDQ)
Time Frame: within one week of the other measures; only for parents of children aged 18 months or older
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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
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within one week of the other measures; only for parents of children aged 18 months or older
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Parental sense of control (PSCO)
Time Frame: within one week of the other measures;
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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.
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within one week of the other measures;
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptance of the Interview
Time Frame: within one week after being interviewed
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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.
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within one week after being interviewed
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- 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)
November 15, 2020
Primary Completion (Actual)
November 27, 2023
Study Completion (Actual)
November 27, 2023
Study Registration Dates
First Submitted
November 29, 2021
First Submitted That Met QC Criteria
November 29, 2021
First Posted (Actual)
December 10, 2021
Study Record Updates
Last Update Posted (Actual)
May 30, 2025
Last Update Submitted That Met QC Criteria
May 23, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID 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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