Anorexia NervosaNCT04095741
Characteristics of Autism Spectrum Disorder in Minors With Anorexia Nervosa in Remission
An observational study of Anorexia Nervosa and Autism Spectrum Disorder, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
With this investigation, researchers wil look for a link between the appearance of anorexia nervosa and autism spectrum disorders in minors. Previous studies made clear already that patients with anorexia nervosa show elevated characteristics of autism spectrum disorder, when being meassured in adults and in patients… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Anorexia Nervosa, Autism Spectrum Disorder
- What is being tested?
- Questionnaires
- How many people
- 34 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2019to 31 Mar 2020
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients were previously treated in UZ Brussel for anorexia nervosa. Intake happened at least one year ago.
Who may be able to join
- Patients speaking Dutch
- Previously treated in UZ Brussel for anorexia nervosa
- Informed consent signed by children and parent(s)
Who cannot join
- Patients and/or parents don't speak Dutch
- Adults
- No informed consent obtained
Trial locations and contacts
1 site in 1 country.
About this study
With this investigation, researchers wil look for a link between the appearance of anorexia nervosa and autism spectrum disorders in minors. Previous studies made clear already that patients with anorexia nervosa show elevated characteristics of autism spectrum disorder, when being meassured in adults and in patients in the acute fase of their anorexia nervosa. The purpose of this invenstigation is to see if their is also an elevated incidence of characteristics of autism spectrum disorder in minors with anorexia nervosa in remission.
Read the detailed description
34 patients who are still minors and were previously treated in the Child and Adolescent Psychiatry Department (PAika) of the University Hospital in Brussels, will be contacted to ask if they would volunteer in this investigation. If the minors and their parents give their permission, they will be asked to fill in multiple questionnaires, measuring the current symptoms of anorexia nervosa, characteristics of autism spectrum disorder and global functioning of the minors. The questionnaires will be send and returned by post.
- Conditions
- Anorexia Nervosa, Autism Spectrum Disorder
- Being tested
- Questionnaires
- Medical subject headings
- Anorexia Nervosa, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesDiagnostic test
Filling in questionnaires of general functioning and symptomes of anorexia nervosa and autism spectrum disorders will demanded to children and their parents. The children all have a history of anorexia nervosa.
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of autism spectrum disorder
Symptoms of autism spectrum disorder will be measured by questionnaires, filled in by the minors (by the Autism-spectrum Quotient) and their parents (by the Social Responsiveness Scale-2 and the Social Communication Questionnaire).
Measured: The measurment will be done once during the period of October 2019 to March 2020.
Secondary outcomes (2)
Global functioning
Global functioning will be measured by questionnaires, filled in by the minors (by the Youth Self Report) and their parents (by the Child Behavior Checklist).
Measured: The measurment will be done once during the period of October 2019 to March 2020
Symptoms of anorexia nervosa
Symptoms of anorexia nervosa will be measured by questionnaires, filled in by the minors (by the Eating Disorder Examination Questionnaire and the Child Eating Disorder Examination Questionnaire) and their parents (by the Anorectic Behavior Observation Scale).
Measured: The measurment will be done once during the period of October 2019 to March 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095741
- Sponsor's protocol ID
- PAIKA2019STUDIE01
- Status last verified
- Sep 2019
- First submitted
- 17 Apr 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Autism Spectrum Disorder in Minors With Anorexia Nervosa in Remission
- ClinicalTrials.gov ID
- NCT04095741
- Acronym / sponsor ID
- PAIKA2019STUDIE01
- Conditions
- Anorexia Nervosa, Autism Spectrum Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 19 Sep 2019 (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.
With this investigation, researchers wil look for a link between the appearance of anorexia nervosa and autism spectrum disorders in minors. Previous studies made clear already that patients with anorexia nervosa show elevated characteristics of autism spectrum disorder, when being meassured in adults and in patients in the acute fase of their anorexia nervosa. The purpose of this invenstigation is to see if their is also an elevated incidence of characteristics of autism spectrum disorder in minors with anorexia nervosa in remission.
Detailed description
34 patients who are still minors and were previously treated in the Child and Adolescent Psychiatry Department (PAika) of the University Hospital in Brussels, will be contacted to ask if they would volunteer in this investigation. If the minors and their parents give their permission, they will be asked to fill in multiple questionnaires, measuring the current symptoms of anorexia nervosa, characteristics of autism spectrum disorder and global functioning of the minors. The questionnaires will be send and returned by post.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients were previously treated in UZ Brussel for anorexia nervosa. Intake happened at least one year ago.
Key inclusion criteria (3 listed)
- Patients speaking Dutch
- Previously treated in UZ Brussel for anorexia nervosa
- Informed consent signed by children and parent(s)
Key exclusion criteria (3 listed)
- Patients and/or parents don't speak Dutch
- Adults
- No informed consent obtained
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesFilling in questionnaires of general functioning and symptomes of anorexia nervosa and autism spectrum disorders will demanded to children and their parents. The children all have a history of anorexia nervosa. | Diagnostic test | – |
Primary outcome
Symptoms of autism spectrum disorder
Time frame: The measurment will be done once during the period of October 2019 to March 2020.
Symptoms of autism spectrum disorder will be measured by questionnaires, filled in by the minors (by the Autism-spectrum Quotient) and their parents (by the Social Responsiveness Scale-2 and the Social Communication Questionnaire).
2 secondary outcomes
Global functioning
Time frame: The measurment will be done once during the period of October 2019 to March 2020
Symptoms of anorexia nervosa
Time frame: The measurment will be done once during the period of October 2019 to March 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anorexia Nervosa and Autism Spectrum Disorder, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 3 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 19 Sep 2019. 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 Belgium. 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?
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?
Symptoms of autism spectrum disorder (time frame: The measurment will be done once during the period of October 2019 to March 2020.). 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 19 Sep 2019.