Condition category
Digestive System
Date applied
15/01/2007
Date assigned
15/01/2007
Last edited
07/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.amc.uva.nl/

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18450876

Publication citations

  1. 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.

Additional files

Editorial Notes