Contact information
Type
Scientific
Primary contact
Dr Marc A Benninga
ORCID ID
Contact details
Academic Medical Center (AMC)
Emma Children's Hospital
Department of Pediatric Gastroenterology and Nutrition
Room G8-261
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 3053
m.a.benninga@amc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SWO 02-16
Study information
Scientific title
Acronym
Study hypothesis
Behavioural therapy in addition to conventional treatment is more effective than conventional treatment alone.
Ethics approval
Approval received from the Medisch Ethische Commissie (Medical Ethical Committee) Academisch Medisch Centrum (AMC) on the 16th October 2002 (ref: MEC02/175 #02.17.1108).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Constipation
Intervention
Intervention period for both Conventional Treatment (CT) and Behavioural Therapy (BT) consisted of 12 visits to the outpatient clinic during 22 weeks.
1. Conventional Treatment:
CT was conducted by pediatric gastroenterologists of the gastrointestinal outpatient clinic and consisted of visits lasting approximately 20 to 30 minutes during which laxative treatment and the bowel diary were discussed. Patients and their parents received education. Furthermore, patients were instructed not to withhold stool when they felt urge to defaecate. Motivation was enhanced by praise and small gifts from the pediatric gastroenterologists.
Protocolised Behavioural Therapy:
BT was developed by pediatric psychologists of the psychosocial department of our hospital and is based on clinical experience and behavioural theories. It includes two age-related modules: a module for children aged four to eight years and a module for children aged more than or equal to eight years. The learning process for child and parents consists of five steps: Know, Dare, Can, Will, and Do.
This approach was derived from a multidisciplinary behavioural treatment developed in a tertiary hospital in Nijmegen in the Netherlands, to treat children with defaecation disorders. Basic assumption of this BT is that fearful and phobic reactions related to defaecation and faecal incontinence can be reduced and that adequate defaecation straining and toileting behaviour can be (re-)acquired by teaching parents behavioural procedures and by behavioural play therapy with the child. Pediatric psychologists in cooperation with co-therapists for children aged four to eight years and without co-therapists for children more than or equal to eight years, carried out BT.
BT consisted of visits lasting approximately 45 minutes. For all involved psychologists a detailed manual for both age related modules was available to ensure a standard delivery of BT. Pediatric psychologist adjusted laxative dose and if necessary consulted a pediatric gastroenterologists.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Defaecation Frequency (DF) per week, Faecal Incontinence Frequency (FIF) per week, successful treatment and relapse. Success was defined as DF more than or equal to three times/week and FIF less than or equal to one time/two weeks irrespectively of laxative use.
A relapse was defined as being unsuccessful at follow-up, while being successful at post-treatment. Assessments were done post-treatment and at six-months follow-up during a clinical visit or by telephone.
Secondary outcome measures
Secondary outcome measures were:
1. Stool-withholding behaviour
2. Mean CBCL T-scores
3. The proportion of children with behavioural scores in the clinical range (T-score more than 63)
Assessments were done post-treatment and at six-months follow-up during a clinical visit or by telephone.
Overall trial start date
01/11/2002
Overall trial end date
01/09/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children aged four to 18 years with functional constipation as defined by the classic Iowa criteria
2. Patients had to meet at least two of four criteria of paediatric constipation:
2.1. Defaecation frequency less than three times per week
2.2. Faecal incontinence frequency two or more times per week
2.3. Passage of large amounts of stool at least once every seven to 30 days (large enough to clog the toilet)
2.4. A palpable abdominal or rectal faecal mass
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
129
Participant exclusion criteria
1. Children were excluded from the study if they had already been treated at our gastrointestinal outpatient clinic or had received a comprehensive behavioural treatment in the previous 12 months
2. In addition, children using drugs influencing gastrointestinal function other than laxative and children with organic causes for defaecation disorders such as Hirschsprung's disease, spina bifida occulta, hypothyroidism or other metabolic or renal abnormalities were excluded
Recruitment start date
01/11/2002
Recruitment end date
01/09/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Center (AMC) (The Netherlands)
Sponsor details
Emma Children's Hospital
Department of Pediatric Gastroenterology and Nutrition
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Dutch Digestive Diseases Foundation (Maag-Lever en Darm Stichting) (MLDS) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/18450876
Publication citations
-
Results
van Dijk M, Bongers ME, de Vries GJ, Grootenhuis MA, Last BF, Benninga MA, Behavioral therapy for childhood constipation: a randomized, controlled trial., Pediatrics, 2008, 121, 5, e1334-41, doi: 10.1542/peds.2007-2402.