Psychological DiseaseNCT05153109
Reliabilty and Validity of a Diagnostic Interview for Parents of Babies and Preescholers
An observational study of Psychological Disease, run by Ruhr University of Bochum at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 71 monthsHealthy volunteers can take part
- Conditions the study is for
- Psychological Disease
- How many people
- 156 participants
- Where
- 2 sitesGermany
- Study dates
- 15 Nov 2020to 27 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 71 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: All parents who have a child in the according age group.
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Ruhr-University
Bochum, North Rhine-Westphalia, 44801
Ludwig Maximilian University of Munich
Munich, Bavaria, 80802
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychological Disease
- Keywords
- clinical interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Kleinkind-DIPS
structured interview for parents of preschoolers
Measured: within one week of the other measures
Secondary outcomes (4)
Fragebogen zum Schreien, Füttern, Schlafen (SFS)
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
Measured: within one week of the other measures; only for parents of children aged 18 months or younger
Depression Anxiety Stress Scale (DASS-21)
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;
Measured: within one week of the other measures;
Strengths and Difficulties Questionnaire (SDQ)
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
Measured: within one week of the other measures; only for parents of children aged 18 months or older
Parental sense of control (PSCO)
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.
Measured: within one week of the other measures;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start15 Nov 2020
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Responsible party
- Principal investigator, Ruth von Brachel, Ruhr University of Bochum
- Investigators
- Silvia Schneider, Phd, Study director, Ruhr University of Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153109
- Sponsor's protocol ID
- 553
- Status last verified
- May 2025
- First submitted
- 29 Nov 2021
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we cannot share individual participant data due to data protection constrictions
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliabilty and Validity of a Diagnostic Interview for Parents of Babies and Preschoolers
- ClinicalTrials.gov ID
- NCT05153109
- Acronym / sponsor ID
- 553
- Conditions
- Psychological Disease
- Keywords
- clinical interview
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 0 to 71 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All parents who have a child in the according age group.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Kleinkind-DIPS
Time frame: within one week of the other measures
structured interview for parents of preschoolers
4 secondary outcomes
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
Depression Anxiety Stress Scale (DASS-21)
Time frame: 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
Parental sense of control (PSCO)
Time frame: within one week of the other measures;
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No. we cannot share individual participant data due to data protection constrictions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Schneider, Phd study director
Ruhr University of Bochum
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Disease, run by Ruhr University of Bochum at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kleinkind-DIPS (time frame: within one week of the other measures). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.