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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
Sponsor:
Information provided by (Responsible Party):
Elisabeth Keuleneer, Universitair Ziekenhuis Brussel

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: positive screenings Other: Screening Questionnaires

Measurement tools:

  • 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.
  • The Aseba Questionnaires are validated diagnostic tools that can be filled in by the parents, teachers or children to evaluate various behavioral and emotional problems. The CBCL assesses internalizing (i.e., anxious, depressive and over-controlled) and externalizing (i.e., aggressive, hyperactive, noncompliant and under-controlled) behaviors.
  • The VG&O 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).




Primary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. Improvement in treatment outcome for functional defecation complaints assessed by Rome IV criteria. [ Time Frame: 6 months ]
  2. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children presenting for the first time at the department of Pediatrics of the Universitair Kinderziekenhuis Brussel with complaints of constipation will be included regardless of previously diagnosed behavioral and developmental health problems and regardless of any previous treatment for functional defecation disorders.
  • Developmental age 4-18 years
  • Children and parents who express themselves fluently in Dutch or French
  • Children who meet the Rome IV criteria for the diagnosis of functional constipation in children
  • Children with developmental age of at least 4 years At least two of the following present at least once per week for at least one month.
  • Two or fewer defecations in the toilet per week
  • At least one episode of fecal incontinence per week
  • History of retentive posturing or excessive volitional stool retention
  • History of painful or hard bowel movements
  • Presence of a large fecal mass in the rectum
  • History of large-diameter stools that may obstruct the toilet
  • The symptoms cannot be fully explained by another medical condition.

Exclusion Criteria:

  • Children with an underlying disease that could have contributed to the development of constipation: Celiac disease, Hypothyroidism, hypercalcemia, hypokalemia, Diabetes mellitus, Dietary protein allergy, Drugs, toxics, Vitamin D intoxication, Botulism, Cystic fibrosis, Hirschsprung Disease, Anal achalasia, Colonic inertia, Anatomic malformations, Pelvic mass (sacral teratoma), Spinal cord anomalies, trauma, tethered cord, Abnormal abdominal musculature (prune belly, gastroschisis, Downsyndrome), Pseudoobstruction (visceral neuropathies, myopathies, mesenchymopathies), Multiple endocrine neoplasia type 2B
  • Children with functional non-retentive fecal incontinence (FNRFI).

Information from the National Library of Medicine

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


Contacts
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Contact: Elisabeth Keuleneer 0476 405 476 elisabeth.keuleneer@vub.be

Locations
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Belgium
Universitair Kinderziekenhuis Brussel Recruiting
Jette, Brussels, Belgium, 1090
Contact: Elisabeth Keuleneer    0476405476 ext 0476405476    elisabeth.keuleneer@vub.be   
Principal Investigator: Elisabeth Keuleneer, 2nd Master in Medicine         
Sub-Investigator: Thierry Devreker, Pediatrics         
Sub-Investigator: Sara Wouters, Child Psychiatry         
Sub-Investigator: Yvan Vandenplas, Pediatrics         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel

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Responsible Party: Elisabeth Keuleneer, Student, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03614000     History of Changes
Other Study ID Numbers: B.U.N. 143201733193
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Constipation
Developmental Disabilities
Problem Behavior
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders
Behavioral Symptoms