- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04095741
Characteristics of Autism Spectrum Disorder in Minors With Anorexia Nervosa in Remission
September 17, 2019 updated by: Universitair Ziekenhuis Brussel
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
34
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
-
-
-
Brussel, Belgium
- UZ Brussel
-
Contact:
- Sara Wouters, Dr.
-
Sub-Investigator:
- Joni Roelandt, Dr.
-
Sub-Investigator:
- Herbert Roeyers, Prof. dr.
-
Principal Investigator:
- Sara Wouters, Dr.
-
-
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
No older than 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients were previously treated in UZ Brussel for anorexia nervosa.
Intake happened at least one year ago.
Description
Inclusion Criteria:
- Patients speaking Dutch
- Previously treated in UZ Brussel for anorexia nervosa
- Informed consent signed by children and parent(s)
Exclusion Criteria:
- Patients and/or parents don't speak Dutch
- Adults
- No informed consent obtained
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
The measurment will be done once during the period of October 2019 to March 2020.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global functioning
Time Frame: The measurment will be done once during the period of October 2019 to March 2020
|
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).
|
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
|
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).
|
The measurment will be done once during the period of October 2019 to March 2020
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (ANTICIPATED)
October 1, 2019
Primary Completion (ANTICIPATED)
March 31, 2020
Study Completion (ANTICIPATED)
March 31, 2020
Study Registration Dates
First Submitted
April 17, 2019
First Submitted That Met QC Criteria
September 17, 2019
First Posted (ACTUAL)
September 19, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 19, 2019
Last Update Submitted That Met QC Criteria
September 17, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAIKA2019STUDIE01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
Clinical Trials on Anorexia Nervosa
-
Rosemary Claire RodenChildren's Miracle NetworkEnrolling by invitationBulimia Nervosa | Impulsive Behavior | Purging (Eating Disorders) | Eating Disorders | Eating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa, Binge Eating/Purging TypeUnited States
-
Fundació Institut de Recerca de l'Hospital de la...Fundació La Marató de TV3RecruitingAnorexia Nervosa | Anorexia Nervosa in Remission | Anorexia Nervosa Restricting TypeSpain
-
Duke UniversityCompletedAdolescent Anorexia Nervosa | Subthreshold Anorexia NervosaUnited States
-
Stanford UniversityNational Institute of Mental Health (NIMH); National Institutes of Health (NIH) and other collaboratorsCompletedAnorexia Nervosa | Anorexia | Eating Disorder | Eating Disorders in Adolescence | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa Restricting Type | Anorexia in ChildrenUnited States
-
University of California, San DiegoRecruitingAnorexia Nervosa | Bulimia Nervosa | Atypical Anorexia Nervosa | Atypical Bulimia NervosaUnited States
-
Linnaeus UniversityGöteborg University; Linkoeping UniversityRecruitingBulimia Nervosa | Major Depression | Anorexia Nervosa/BulimiaSweden
-
Umeå UniversityActive, not recruitingAnorexia Nervosa | Anorexia in Adolescence | Anorexia Nervosa, AtypicalSweden
-
Yeshiva UniversityYale UniversityRecruitingAnorexia Nervosa | Bulimia Nervosa | Anorexia Nervosa, Atypical | Bulimia; AtypicalUnited States
-
The Miriam HospitalUnknownEating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia Nervosa Restricting TypeUnited States
-
University Hospital, AkershusRådgivning om SpiseforstyrrelserEnrolling by invitationAnorexia Nervosa | Atypical Anorexia NervosaNorway
Clinical Trials on Questionnaires
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
Direction Centrale du Service de Santé des ArméesCompleted
-
Sun Yat-sen UniversityNot yet recruiting
-
Assistance Publique - Hôpitaux de ParisRecruitingIntensive Care Unit Syndrome | Pediatric Post-intensive Care SyndromeFrance
-
University Hospital, GrenobleUniversity Grenoble AlpsNot yet recruitingChildhood Cancer | Adapted Physical ActivityFrance
-
M.D. Anderson Cancer CenterCompletedAdvanced Cancer | Malignant Neoplasms of Independent (Primary) Multiple SitesUnited States
-
The University of Hong KongCompleted
-
Centre Hospitalier Universitaire DijonCompleted
-
UNC Lineberger Comprehensive Cancer CenterCompletedBreast Cancer | MetastasisUnited States
-
Cliniques universitaires Saint-Luc- Université...Fonds National de la Recherche ScientifiqueNot yet recruitingAlcohol Use Disorder