Trial document




drksid header

  DRKS00015321

Trial Description

start of 1:1-Block title

Title

Incontinence, comorbidities and parental stress in children and adolescents with Attention Deficit Hyperactivity Disoder (ADHD)

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Many children and adolescents suffer from an attention deficit with or without impulsivity and hyperactivity. Lots of them are clinically diagnosed with an Attention Deficit (Hyperactivity) disorder. This disorder oftenly has a great impact on daily functioning at home, in school or Kindergarten.
Fortunately, up to now there are several therapeutical interventions available to treat ADHD, such as parental trainings, self-instruction trainings or medication. These treatments are already well studied and established. Many studies focussed on treatment and associated outcomes in ADHD.
But there are some aspects about ADHD, which are still poorly understood. One of these aspescts concerns a higher prevalence rate for ADHD and comorbid incontinence in children and adolescents, which is much higher than expected by chance.

The archievment of bladder and bowel controls marks one of several important developmental milestones having a high impact on social functioning and self-care abilities . Incontinence is most oftenly associated with higher care requirements and less social acceptance leading to higher parental stress levels.

The Department of Child and Adolescent Psychiatry at the Saarland University Medical Center conducts a study about the prevalence and comorbidity of nocturnal enuresis and daytime urinary incontinence in children with ADHD. We are also interested in associations between ADHD and incontinence with somatic parameters (e.g. BMI) or psychiatric aspects (i.e. comorbid psychiatric disorders, e.g. depression or anxiety) as well as levels of parental stress in this clinical sample.
We focus on the development of better counseling and treatment offers for patients, parents and associated attachment figures (e.g. teachers).

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Incontinence: The International Children's Continence Society (ICCS) specified different subtypes of nocturnal enuresis (NE) and daytime urinary incontinence (DUI; Austin et al., 2016). NE is defined as any intermittent leakage of urine, occurring at least once per month in a child above the age of 5 years, which is not caused by any organic disease or disorder. According to the presence or absence of a) any completely dry episode for at least six months or b) an additional DUI, primary and secondary as well as monosymptomatic and non-monosymptomatic NE are differentiated (Austin et al., 2016).
Daytime urinary incontinence (DUI) is defined as any intermittent wetting during the day in a child of at least 5 years after any organic causes are ruled out (Austin et al., 2016). The ICCS developed criteria to distinguish between several DUI subtypes, such as e.g. voiding postponement or urge incontinence (Austin et al., 2016). Prevalence rates in 7-year-olds are estimated at about 10% for NE and 2-3% for DUI (von Gontard & Equit, 2015). In the ICD-10 classification system, encopresis is diagnosed in children above the age of 4 years, who show intermittent fecal incontinence with or without constipation (Dilling und Freyberger, 2016; Rasquin et al., 2006; Hyams et al., 2016) after organic causes are ruled out.
Attention Deficit (Hyperactivity) Disorder: According to the DSM-IV, Attention Deficit Hyperactivity disorders (ADHD) are defined by three core symptoms, namely a) Attention or concentration deficit, b) impulsivity and c) hyperactivity (APA, 2013). These symptoms have to be persistantly present in the course of the child's development. If all three core symptoms are present, the combined subtype is diagnosed. In children mainly suffering from attention deficit (predominantly inattentive presentation) or mainly showing hyperactivity and impulsivity (predominantly hyperactive / impulsive presentation), two other subtypes are available to describe the phenomenology (APA, 2013). The ICD-10 classification system does not provide a seperate category for the inattentive type, which has to be classified in a residual diagnosis category (F98.8) with other unspecified disorders (such as e.g. nail-biting or nose-picking; Dilling & Freyberger, 2016). Worldwide prevalence rates of ADHD are estimated at about 5 to 7.2% (Polanczyk et al., 2014; Thomas et al., 2015). Hypotheses about the etiology of ADHD mainly focus on a high relevance of genetics with an estimated heritability of 75% (Faraone et al., 2005). Further risk factors are low birth weight, preterm birth and maternal nicotine abuse in pregnancy (APA, 2013; Moriyama et al., 2012). Further psychological factors seem to have a negative impact on the symptomatology, such as e.g. children's temperament (APA, 2013). ADHD treatment should follow a multimodal approach, combining psychoeducation, parent training, self instruction training as well as interventions in school or kindergarten. Medication (e.g. Methyphenidat, MPH) is mainly recommended in hyperactive school children (NICE Guidelines ADHD: https://www.nice.org.uk/guidance/NG87). Common comorbidities in children suffering from ADHD are neuropsychological deficits (e.g. executive functiononing), emotional disorders, affective disorders, tic disorders, substance abuse, conduct disorders as well as deficits in academic or motor development (Tarver et al., 2014).
ADHD and incontinence: Reviewing the literature, just a few studies focused on the prevalence of incontinence in children with ADHD, which seem to be very high (von Gontard & Equit, 2015). Robson et al. (1997) used a retrospective study design. They found a higher probability in 10-11 year old children with ADHD to additionally suffer from NE (Odds Ratio: 2.6) or DUI (Odds ratio: 11.7).
On the other hand, several studies reported comorbid ADHD symptoms in incontinent children, especially in those with NE. In a study from Bayens et al. (2004), 40% of the children with NE suffered from a comorbid ADHD. Okur et al. (2012) estimated the prevalence of ADHD at up to 53% in children with NE. Furthermore, prevalence rates of ADHD in children with FI are reported at about 10.5 - 21% (Kodman-Jones et al., 2001; Zink et al., 2008).
Most of the studies addressing comorbid ADHD and incontince used interviews or questionnaires to assess clinical symptoms, which implies a subjective reporting bias. Hence, we are going to use additional somatic assessment methods (e.g. sonography) to collect objective data concerning functional incontinence and symptoms of the lower urinary tract.
Parental distress in children with ADHD and / or incontinence: Many studies focused on parental stress associated with children suffering from ADHD. They mainly used questionnaires, e.g. the Parenting Stress Index (Aibidin, 1995). In a recent meta anlysis, Theule et al. (2013) found higher parental stress levels in parents of children suffering from ADHD compared to parents of typically developed children. But parental stress intensity seems to be comparable to that of parents of children suffering from any other psychiatric disorder. Other studies found higher parental stress rates in parents of children with ADHD than in those with any anxiety disorder or other neurodevelopmental disorders, which in sum seems to be comparable to the parental stress intensity in parents of children with autism spectrum disorders (Telman et al., 2017).
Parental stress seems to be higher in parents of children with comorbid oppositional defiant disorder (ODD; Yan et al., 2006). High parental stress affects parents' self-reported quality of life (Cappe et al., 2017) as well as parental estimation of ADHD symptom severity in the child (Chen et al., 2017; Breaux & Harvey, 2018) negatively. ADHD treatment effects are oftenly associated with a reduction of parental stress (Hwang et al., 2013; Silva et al., 2015; Heath et al., 2015; Lo et al., 2017).
Just a few studies addressed parental stress in parents of incontinent children (De Bruyne et al., 2009; Equit et al., 2014). Higher parental stress rates are reported in parents of children with Fi (Cushing et al., 2016), especially in children with FI and constipation compared to those with constipation alone (Kovacic et al., 2016). To our best knowledge, no study addressed parental stress in children with ADHD and comorbid incontinence up to now.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00015321
  •   2018/09/19
  •   [---]*
  •   yes
  •   Approved
  •   120/18, Ethik-Kommission bei der Ärztekammer des Saarlandes
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F98.0 -  Nonorganic enuresis
  •   N39.4 -  Other specified urinary incontinence
  •   F90.0 -  Disturbance of activity and attention
  •   F90.1 -  Hyperkinetic conduct disorder
  •   F98.8 -  Other specified behavioural and emotional disorders with onset usually occurring in childhood and adolescence
  •   F98.1 -  Nonorganic encopresis
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   80 children / adolescents with tentative or confirmed AD(H)D, who introduce themselves at our out-patient clinic, are asked to participate once in the following assessments:

    Children / Adolescents: 1. Intelligence Test (RIAS); 2. Uroflow; 3. Abdominal Sonography (bladder, bladder wall, rectum, residual urine); 4. General somatic Screening (internal and neurological);
    Parents: 1. General psychiatric interview (Kinder-DIPS); 2. Child Behavior Checklist 4-18 (CBCL); 3. Enuresis / Encopresis Questionnaire to assess ROME-IV- and ICCS-criteria; 4. 48 hour micturition protocol; 5. Parental Questionnaire about ADHD symptoms (DISYPS-II-FBB-ADHS); 6. Assessment of parental distress (Elternstressfragebogen, ESF).

  •   80 typically developed children / adolescents are asked to participate once in the following assessments:

    Children / Adolescents: 1. Intelligence Test (RIAS); 2. Uroflow; 3. Abdominal sonography (bladder, bladder wall, rectum, residual urine); 4. General somatic Screening (internal and neurological);
    Parents: 1. General psychiatric interview (Kinder-DIPS); 2. Child Behavior Checklist 4-18 (CBCL); 3. Enuresis / Encopresis Questionnaire to assess ROME-IV- and ICCS-criteria; 4. 48 hour micturition protocol; 5. Parental Questionnaire about ADHD symptoms (DISYPS-II-FBB-ADHS); 6. Assessment of parental distress (Elternstressfragebogen, ESF).
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Basic research/physiological study
  •   Parallel
  •   [---]*
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

1.) Prevalence of incontinence (Enuresis: F98.0; Daytime urinary incontinence: N39.4; Encopresis: F98.1) in children with AD(H)D (Disturbance of activity and attention: F90.0; Hyperkinetic conduct disorder: F90.1; Attention deficit disorder without hyperactivity: F98.8).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

1.) Psychiatric comorbidities or psychopathological symptoms in children and adolescents with AD(H)D (F90.0; F90.1; F98.8) and / or incontinence (F98.0; N39.4; F98.1).
2.) Degree of parental distress in children with a) AD(H)D, b) Enuresis / Daytime urinary incontinence / Encopresis, and c) children with AD(H)D and comorbid incontinence.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2018/10/15
  •   160
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   5   Years
  •   18   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

In the clinical sample: A tentative or confirmed Disorder of activity and attention (F90.0), Hyperkinetic conduct disorder (F90.1) or Attention deficit withour hyperactivity (F98.8).
In the control Group: Exclusion of a Disorder of activity and attention (F90.0), Hyperkinetic conduct disorder (F90.1) or Attention deficit withour hyperactivity (F98.8).

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

1.) Severe somatic diseases; 2.) Mental disability (IQ < 70).

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.