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

ISRCTN	ISRCTN25185569
DOI	https://doi.org/10.1186/ISRCTN25185569
Protocol serial number	SWO 02-16
Sponsor	Academic Medical Center (AMC) (The Netherlands)
Funder	Dutch Digestive Diseases Foundation (Maag-Lever en Darm Stichting) (MLDS) (The Netherlands)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Behavioural 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) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/09/2005

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	4 Years
Upper age limit	18 Years
Sex	All
Target sample size at registration	129
Key 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
Key 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
Date of first enrolment	01/11/2002
Date of final enrolment	01/09/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Center (AMC)

Amsterdam
1100 DD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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