Premature BirthNCT02628015
Theory of Mind in Preschool Children, School Children, Youths and Adults Born Preterm or Full-term
An observational study of Premature Birth, run by University of Bonn at 1 site in Germany.
Trial summary
This study tests preschoolers, school children, youths and young adults, who were born preterm or full-term, in their theory of mind abilities. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- How many people
- 480 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2016to Dec 2018
- 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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: preterms were born in the University Hospital of Cologne
Who may be able to join
- informed consent
- preterm: birthweight <1500g
- full-term: born after 38 weeks
Who cannot join
- no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Theory of Mind Bei Ehemals früh- Und Reifgeborenen Vorschulkindern, Schulkindern, Jugendlichen Und Erwachsenen
This study tests preschoolers, school children, youths and young adults, who were born preterm or full-term, in their theory of mind abilities.
Read the detailed description
Is there any difference in the development of theory of mind between preterms and full-terms? Is there a risk group of preterms to develop a deficit in theroy of mind?
Four groups are tested: prescoolers (again two years later), youths and young adults.
All participants were tested for theory of mind, executive functions, language and cognitive abilites.
- Conditions
- Premature Birth
- Keywords
- Theory of Mind, Very Low Birthweight Infants
- Medical subject headings
- Premature Birth
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 |
|---|---|---|
| preschool children preterm | born 2010 or 2011 Birthweight <1500g | |
| preschool children full-term | born 2010 or 2011 born after 38 weeks | |
| school children preterm | same children from the preschool group will be tested 2 years later again | |
| school children full-term | same children from the preschool group will be tested 2 years later again | |
| youths preterm | born 2001 or 2002 Birthweight <1500g | |
| youths full-term | born 2001 or 2002 born after 38 weeks | |
| adults preterm | Birthweight <1500g | |
| adults full-term | born after 38 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
theory of mind 1
Theory of Mind Scale (Group 1 and 2)
Measured: up to 7 months
executive function 1
Teddy-bear-Set-Shifting Task (all groups)
Measured: up to 7 months
executive function 2
Tower of London (all groups)
Measured: up to 7 months
Language 1
SETK 3-5 - Language Understanding Task (Group 1)
there will be only one score for each participant, but there is a different task for the first group, than for the others
Measured: up to 7 months
cognitive abilities 1
SON 2 1/2 - 7 - Two subtests: Analogies and Categories (group 1) there will be two test-scores for each participant, but they can be aggregated to one score for cognitive abilities
Measured: up to 7 months
theory of mind 2
Mental State Stories (Group 2, 3 and 4)
Measured: up to 7 months
theory of mind 3
Faux Pas Stories (Group 2, 3, and 4)
Measured: up to 7 months
theory of mind 4
Reading the mind in the Eyes Test Revised (Group 4)
Measured: up to 7 months
theory of mind 5
Cambridge Mindreading Face-Voice Battery (only visual Items) (Group 4)
Measured: up to 7 months
Language 2
CFT 20 R - Vocabulary Task (group 2,3,4)
Measured: up to 7 months
cognitive abilities 2
SON 6-40 - Two subtests: Analogies and Categories (group 2,3,4) there will be two test-scores for each participant, but they can be aggregated to one score for cognitive abilities
Measured: up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startMar 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Cologne
- Responsible party
- Principal investigator, Stephanie Braun, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628015
- Sponsor's protocol ID
- ToM-2016-2018
- Status last verified
- Mar 2016
- First submitted
- 14 Nov 2015
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theory of Mind Bei Ehemals früh- Und Reifgeborenen Vorschulkindern, Schulkindern, Jugendlichen Und Erwachsenen
- ClinicalTrials.gov ID
- NCT02628015
- Acronym / sponsor ID
- ToM-2016-2018
- Conditions
- Premature Birth
- Keywords
- Theory of Mind, Very Low Birthweight Infants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- University of BonnUniversity, hospital or other
- Collaborators
- University Hospital of Cologne
- Study start
- Mar 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 11 Dec 2015 (estimated)
- 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.
This study tests preschoolers, school children, youths and young adults, who were born preterm or full-term, in their theory of mind abilities.
Detailed description
Is there any difference in the development of theory of mind between preterms and full-terms? Is there a risk group of preterms to develop a deficit in theroy of mind?
Four groups are tested: prescoolers (again two years later), youths and young adults.
All participants were tested for theory of mind, executive functions, language and cognitive abilites.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| preschool children preterm | – | –born 2010 or 2011 Birthweight <1500g |
| preschool children full-term | – | –born 2010 or 2011 born after 38 weeks |
| school children preterm | – | –same children from the preschool group will be tested 2 years later again |
| school children full-term | – | –same children from the preschool group will be tested 2 years later again |
| youths preterm | – | –born 2001 or 2002 Birthweight <1500g |
| youths full-term | – | –born 2001 or 2002 born after 38 weeks |
| adults preterm | – | –Birthweight <1500g |
| adults full-term | – | –born after 38 weeks |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- preterms were born in the University Hospital of Cologne
Key inclusion criteria (3 listed)
- informed consent
- preterm: birthweight <1500g
- full-term: born after 38 weeks
Key exclusion criteria (1 listed)
- no informed consent
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
theory of mind 1
Time frame: up to 7 months
Theory of Mind Scale (Group 1 and 2)
executive function 1
Time frame: up to 7 months
Teddy-bear-Set-Shifting Task (all groups)
executive function 2
Time frame: up to 7 months
Tower of London (all groups)
Language 1
Time frame: up to 7 months
SETK 3-5 - Language Understanding Task (Group 1) there will be only one score for each participant, but there is a different task for the first group, than for the others
cognitive abilities 1
Time frame: up to 7 months
SON 2 1/2 - 7 - Two subtests: Analogies and Categories (group 1) there will be two test-scores for each participant, but they can be aggregated to one score for cognitive abilities
theory of mind 2
Time frame: up to 7 months
Mental State Stories (Group 2, 3 and 4)
theory of mind 3
Time frame: up to 7 months
Faux Pas Stories (Group 2, 3, and 4)
theory of mind 4
Time frame: up to 7 months
Reading the mind in the Eyes Test Revised (Group 4)
theory of mind 5
Time frame: up to 7 months
Cambridge Mindreading Face-Voice Battery (only visual Items) (Group 4)
Language 2
Time frame: up to 7 months
CFT 20 R - Vocabulary Task (group 2,3,4)
cognitive abilities 2
Time frame: up to 7 months
SON 6-40 - Two subtests: Analogies and Categories (group 2,3,4) there will be two test-scores for each participant, but they can be aggregated to one score for cognitive abilities
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth, run by University of Bonn at 1 site 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 3 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: status not confirmed, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Braun, M.Sc. (0049 228 73 ext. 4472, stbraun@uni-bonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
theory of mind 1 (time frame: up to 7 months). The study lists 11 primary outcomes in all. 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 14 Mar 2016.