Functional ConstipationNCT03614000
Early Screening of Emotional, Behavioral and Autism Spectrum Disorders in Children With Functional Constipation.
A study testing Screening Questionnaires in people with Functional Constipation and Emotional Problems, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Functional Constipation, Emotional Problems, Behavioural Problems
- What is being tested?
- Screening Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Jan 2018to 12 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Secretariaat Kinderpsychiatrie contact
Belgium1 site, 1 recruiting
- Recruiting
Universitair Kinderziekenhuis Brussel
Jette, Brussels Capital, 1090
Elisabeth Keuleneer, 024776072, elisabeth.keuleneer@uzbrussel.be
Elisabeth Keuleneer, ASO Child psychiatry
About this study
Official title: Early Screening for Emotional, Behavioral and Autism Spectrum Disorders in Children With Functional Constipation.
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.
Read the 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.
- Conditions
- Functional Constipation, Emotional Problems, Behavioural Problems, Developmental Disorder, Autism Spectrum Disorder
- Being tested
- Screening Questionnaires
- Keywords
- Childhood Constipation
- Medical subject headings
- Mental Disorders, Developmental Disabilities, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening QuestionnairesOther
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
| Study group | Role | What they receive |
|---|---|---|
| positive screenings | Experimental | Not described Receives: Other: Screening Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start12 Jan 2018
- Primary completion12 Aug 2021 (estimated)
- Study completion12 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional ConstipationStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabeth Keuleneer, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614000
- Sponsor's protocol ID
- B.U.N. 143201733193
- Status last verified
- May 2020
- First submitted
- 7 Jul 2018
- Last updated
- 22 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Screening for Emotional, Behavioral and Autism Spectrum Disorders in Children With Functional Constipation.
- ClinicalTrials.gov ID
- NCT03614000
- Acronym / sponsor ID
- B.U.N. 143201733193
- Conditions
- Functional Constipation, Emotional Problems, Behavioural Problems, Developmental Disorder, Autism Spectrum Disorder
- Keywords
- Childhood Constipation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 12 Aug 2021 (estimated)
- Study completion
- 12 Oct 2021 (estimated)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| positive screenings | Experimental | Other: Screening Questionnaires |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening QuestionnairesMeasurement 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 | Other | positive screenings |
Primary outcome
The prevalence of internalizing and externalizing behavioural problems as assessed by the Aseba questionnaires
Time frame: 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.
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Secretariaat Kinderpsychiatrie contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening Questionnaires in people with Functional Constipation and Emotional Problems, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisabeth Keuleneer (024776072, elisabeth.keuleneer@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of internalizing and externalizing behavioural problems as assessed by the Aseba questionnaires (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2020.