Behavioural therapy for treatment of childhood constipation: a randomised controlled trial

ISRCTN ISRCTN25185569
DOI https://doi.org/10.1186/ISRCTN25185569
Secondary identifying numbers SWO 02-16
Submission date
15/01/2007
Registration date
15/01/2007
Last edited
07/05/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Marc A Benninga
Scientific

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

Phone +31 (0)20 566 3053
Email m.a.benninga@amc.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesBehavioural therapy in addition to conventional treatment is more effective than conventional treatment alone.
Ethics approval(s)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).
Health condition(s) or problem(s) studiedConstipation
InterventionIntervention 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 typeOther
Primary outcome measureDefaecation 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 measuresSecondary 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 study start date01/11/2002
Completion date01/09/2005

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit4 Years
Upper age limit18 Years
SexBoth
Target number of participants129
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/11/2002
Date of final enrolment01/09/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Center (AMC) (The Netherlands)
Hospital/treatment centre

Emma Children's Hospital
Department of Pediatric Gastroenterology and Nutrition
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Website http://www.amc.uva.nl/
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Research organisation

Dutch Digestive Diseases Foundation (Maag-Lever en Darm Stichting) (MLDS) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/05/2008 Yes No