跳至主要内容
临床试验/NCT03614000
NCT03614000Unknown不适用

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

Universitair Ziekenhuis Brussel2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年1月12日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
The prevalence of internalizing and externalizing behavioural problems as assessed by the Aseba questionnaires

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
4 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

结局指标

主要结局

The prevalence of internalizing and externalizing behavioural problems as assessed by the Aseba questionnaires

时间窗: 1 year

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.

时间窗: 1 year

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elisabeth Keuleneer

ASO Kinder- en Jeugdpsychiatrie

Universitair Ziekenhuis Brussel

研究点 (2)

Loading locations...

相似试验