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

NCT03614000 | Unknown

• 1 other identifier: B.U.N. 143201733193
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Constipation; Emotional Problems; Behavioural Problems; Developmental Disorder; Autism Spectrum Disorder

Keywords

Childhood Constipation

Outcome Measures

Primary Outcomes (2)

• 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.

  1 year

• 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.

  1 year

Other Outcomes (1)

• The number of positive screens for parental stress as assessed by the OBVL questionnaires.

  1 year

Study Arms (1)

positive screenings

EXPERIMENTAL

Other: Screening Questionnaires

Interventions

Screening Questionnaires OTHER

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

positive screenings

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Kinderziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Mental Disorders; Developmental Disabilities; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Child Development Disorders, Pervasive

Central Study Contacts

Elisabeth Keuleneer

CONTACT

024776072; elisabeth.keuleneer@uzbrussel.be

Secretariaat Kinderpsychiatrie

CONTACT

024776072

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASO Kinder- en Jeugdpsychiatrie

Study Record Dates

• First Submitted: July 7, 2018
• First Posted: August 3, 2018
• Study Start: January 12, 2018
• Primary Completion: August 12, 2021
• Study Completion: October 12, 2021
• Last Updated: May 22, 2020

Record last verified: 2020-05

Locations

BE (1)