Behavioral therapy for treatment of childhood constipation: a randomized controlled trial.

Completed

Conditions: Functional constipation.

Registration Number: NL-OMON23675

Lead Sponsor: This research was funded by grants from the MLDS (SWO 02-16).

Brief Summary: Pediatrics. 2008 May;121(5):e1334-41.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 129

Inclusion Criteria

Children aged 4-18 years with functional constipation as defined by the classic Iowa criteria. Patients had to meet at least two of four criteria of pediatric constipation: defecation frequency less than three times per week, fecal incontinence frequency two or more times per week, passage of large amounts of stool at least once every 7-30 days (large enough to clog the toilet), or a palpable abdominal or rectal fecal mass.

Exclusion Criteria

Children were excluded from the study if they had already been treated at our gastrointestinal outpatient clinic or had received a comprehensive behavioral treatment in the previous 12 months. In addition, children using drugs influencing gastrointestinal function other than laxative and children with organic causes for defecation disorders such as Hirschsprung's disease, spina bifida occulta, hypothyroidism or other metabolic or renal abnormalities were excluded.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Defecation frequency (DF) per week, fecal incontinence frequency (FIF) per week, successful treatment and relapse. Success<br>was defined as DF >= 3 times/week and FIF <= 1 times/two weeks irrespectively of laxative use. A relapse was defined as being unsuccessful at follow-up, while being successful at posttreatment. Assessments were done posttreatment and at 6-months follow-up during a clinical visit or by telephone.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures were: stool-withholding behavior, mean CBCL T-scores and the proportion of children with behavioral scores in the clinical range (T-score>63). Assessments were done posttreatment and at 6-months follow-up during a clinical visit or by telephone.