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Early Screening of Emotional, Behavioral and Autism Spectrum Disorders in Children With Functional Constipation.

Primary Purpose

Functional Constipation, Emotional Problems, Behavioural Problems

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Screening Questionnaires
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Functional Constipation focused on measuring Childhood Constipation

Eligibility Criteria

4 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Universitair Kinderziekenhuis BrusselRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

positive screenings

Arm Description

Outcomes

Primary Outcome Measures

The prevalence of internalizing and externalizing behavioural problems as assessed by the Aseba questionnaires
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.
The prevalence of behavioural and social responsiveness problems as assessed by the Social Responsiveness Scale-2.
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.

Secondary Outcome Measures

Full Information

First Posted
July 7, 2018
Last Updated
May 20, 2020
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT03614000
Brief Title
Early Screening of Emotional, Behavioral and Autism Spectrum Disorders in Children With Functional Constipation.
Official Title
Early Screening for Emotional, Behavioral and Autism Spectrum Disorders in Children With Functional Constipation.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 12, 2018 (Actual)
Primary Completion Date
August 12, 2021 (Anticipated)
Study Completion Date
October 12, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
A significant group of children with functional constipation (FC) continues to have symptoms despite recommended standard therapy. Underlying psychiatric problems could explain therapy resistance. However, a work-up for psychiatric problems is only recommended after unsuccessful 6 months standard therapy. Earlier detection and check-up could lead to faster start-up of a more adequate therapy. Therefore, we investigate the prevalence of emotional, behavioural and social problems in the FC-population at the first contact with a paediatric gastroenterologist in a tertiary care hospital.
Detailed Description
The diagnosis of functional constipation (FC) in children leads to several diagnostic and therapeutic challenges. Most children respond well to standard recommended treatment, but there is a considerable group of patients that will continue to have symptoms. In this group, paediatricians sometimes presume the presence of an underlying psychopathology such as a developmental disorder, mood disorder, behavioural disorder. A longer treatment period has shown strong association with behavioural problems, suggestive for treatment resistant constipation. It is known that functional defecation disorders (FDD) can be associated with behavioural and developmental disorders, such as Autism Spectrum Disorder (ASD) and Attention Deficit and Hyperactivity Disorder (ADHD), though these disorders are often initially unrecognized. Also, there are no clear guidelines reported regarding the timing when to search for underlying psychopathology in FC. Research using Social Responsiveness Scale (SRS) and Social Communication Questionnaire-Lifetime (SCQ-L), screening tools for social difficulties, did not identify ASD diagnosis, in children with functional constipation. At the other hand, they found a total increase in emotional and behavioural problems in their research group. Prior studies found that 28 % of children with FDD referred to a tertiary centre scored positive on ASD screening questionnaires. A high prevalence of behavioural problems (37 %) in children with FC has been described as well. According to the Guidelines for children with FC of the North American and European Societies of Paediatric Gastroenterology, Hepatology and Nutrition, the diagnosis of emotional, behavioural and/or developmental disorders (ASD or ADHD) will be considered after an unsuccessful six-month standard treatment. We hypothesized that it could be useful to incorporate an earlier screening for emotional, behavioural and autism spectrum disorders into the diagnostic work-up of children with functional constipation referred to a tertiary care hospital. FC may have an important impact on the Quality of Life (QoL) in families of these children. Therefore we also measure parental stress and negative life-events from the child's perspective using the 'Opvoedingsbelasting Vragenlijst' (OBVL) for measurement of parental stress and the 'Vragenlijst Meegemaakte Gebeurtenissen' (VMG) for possible stressful life events from the child's perspective. This study includes Dutch and French-speaking children, age 4-18 years, presenting for the first time at KidZ Health Castle (KHC) Brussels with suspicion of functional constipation complaints. Children could present ambulatory or could be hospitalized and were eligible regardless of previously diagnosed behavioural and developmental problems and regardless of any previous treatment for FDD. The diagnosis of FC was made based on the Rome IV criteria. Given that the 2 month interval listed in the Rome IV criteria for older children may unfairly delay treatment in some children with constipation, children who had difficulty with defecation for at least 2 weeks were also included 3. Children with an underlying organic cause that could have contributed to the development of constipation and children with functional non-retentive faecal incontinence (FNRFI) will be excluded. The questionnaires will be given to the consenting parents and/or patients at the first visit and after 6 months conventional treatment along with an explanation of the research by the attending pediatrician, informed consent and a return envelope. Each questionnaire will be anonymized and provided with a code that will be linked to the name and number of the participant's file. The group within the normal range at first visit for the two screening surveys: SRS-2 and CBC-L will serve as a control group. Both groups will have to fill in the 2 questionnaires 6 months later, after initiation of adequate treatment. If the control results are still abnormal, participants will be directed to the department of Child and Adolescent Psychiatry for further treatment of their behavioral, emotional or developmental problems. Participants will be seen every 2 - 3 months and outcome will be evaluated at 6 and 12 months after enrollment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Constipation, Emotional Problems, Behavioural Problems, Developmental Disorder, Autism Spectrum Disorder
Keywords
Childhood Constipation

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
positive screenings
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Screening Questionnaires
Intervention Description
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). The OBVL will be used
Primary Outcome Measure Information:
Title
The prevalence of internalizing and externalizing behavioural problems as assessed by the Aseba questionnaires
Description
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.
Time Frame
1 year
Title
The prevalence of behavioural and social responsiveness problems as assessed by the Social Responsiveness Scale-2.
Description
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.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
The number of positive screens for parental stress as assessed by the OBVL questionnaires.
Description
The OBVL is a part of the VG&O, a questionnaire developed in Dutch that gives information about parental stress.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth Keuleneer
Phone
024776072
Email
elisabeth.keuleneer@uzbrussel.be
First Name & Middle Initial & Last Name or Official Title & Degree
Secretariaat Kinderpsychiatrie
Phone
024776072
Facility Information:
Facility Name
Universitair Kinderziekenhuis Brussel
City
Jette
State/Province
Brussels
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth Keuleneer
Phone
024776072
Email
elisabeth.keuleneer@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Elisabeth Keuleneer, ASO Child psychiatry
First Name & Middle Initial & Last Name & Degree
Thierry Devreker, Pediatrics
First Name & Middle Initial & Last Name & Degree
Sara Wouters, Child Psychiatry
First Name & Middle Initial & Last Name & Degree
Yvan Vandenplas, Pediatrics

12. IPD Sharing Statement

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Early Screening of Emotional, Behavioral and Autism Spectrum Disorders in Children With Functional Constipation.

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