Screening for Emotional, Behavioral and Developmental Disorders in Children With Functional Constipation.
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|ClinicalTrials.gov Identifier: NCT03614000|
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : August 3, 2018
In children with functional constipation pediatricians often find the presence of an underlying psychopathology (developmental disorder, mood disorder, behavioral disorder...). However, there are no unambiguous guidelines regarding the time of the questioning of underlying psychopathology in children reported for functional constipation.
On the other hand, there are no general screening tools available.
In this research, the investigators want to examine whether taking a few specific behavioral questionnaires at first signaling offers added value in the possible earlier detection of underlying psychopathology.
An earlier detection could lead to a faster start-up of adapted therapy.
To collect this data the investigators will use questionnaires completed by parents (and children) at the first contact with the doctor and after 6 months. If children are detected with underlying psychopathology they will be directed to the child and adolescent psychiatry department.
|Condition or disease||Intervention/treatment||Phase|
|Functional Constipation Emotional Disorder Behavioral Disorder Developmental Disorder||Other: Screening Questionnaires||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Screening for Emotional, Behavioral and Developmental Disorders in Children With Functional Constipation.|
|Actual Study Start Date :||January 12, 2018|
|Estimated Primary Completion Date :||February 12, 2019|
|Estimated Study Completion Date :||March 12, 2019|
|Experimental: positive screenings||
Other: Screening Questionnaires
- Change over time in the prevalence of behavioral and developmental problems as assessed by the Social Responsiveness Scale-2. [ Time Frame: 6 months ]Social Responsiveness Scale (SRS-2) is a validated 65-item scale for the screening of ASD that requires parents to rate the child's behaviors in the previous 6 months. The questionnaire assesses interpersonal behavior, communication and repetitive/stereotypic behavior characteristics of ASD.
- Change over time in the prevalence of internalizing and externalizing behavioral problems as assessed by the Aseba Questionnaires. [ Time Frame: 6 months ]The set of Aseba Questionnaires is a validated diagnostic tool that can be filled in by the parents, teachers or children to evaluate various behavioral and emotional problems. It assesses internalizing (i.e., anxious, depressive and over-controlled) and externalizing (i.e., aggressive, hyperactive, noncompliant and under-controlled) behaviors. It is the most widely used instrument for assessing child behavioral and emotional symptoms and can be converted into standardized scores (e.g., T scores Mean = 50, SD = 10) with higher scores indicating more emotional problems.
- Improvement in treatment outcome for functional defecation complaints assessed by Rome IV criteria. [ Time Frame: 6 months ]
- Change in levels of stress in parents of children with functional constipation assessed by the Vragenlijsten Gezin en Opvoeding (VG&O). [ Time Frame: 6 months ]The VG&O is a questionnaire developed in Dutch that gives a subscale of parental stress (OBVL), family functioning (VGFO), education habits (VSOG) and life events (VMG).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614000
|Contact: Elisabeth Keuleneer||0476 405 email@example.com|
|Universitair Kinderziekenhuis Brussel||Recruiting|
|Jette, Brussels, Belgium, 1090|
|Contact: Elisabeth Keuleneer 0476405476 ext 0476405476 firstname.lastname@example.org|
|Principal Investigator: Elisabeth Keuleneer, 2nd Master in Medicine|
|Sub-Investigator: Thierry Devreker, Pediatrics|
|Sub-Investigator: Sara Wouters, Child Psychiatry|
|Sub-Investigator: Yvan Vandenplas, Pediatrics|