Functional abdominal pain (FAP) within the context of internalizing disorders in childhood; A randomized controlled cognitive-behavioural family intervention.
Completed
- Conditions
- Functional abdominal pain (FAP) in children aged 8-18 [functionele buikpijn bij kinderen van 8-18]. FAP can also be described as:- recurrent abdominal pain [terugkerende buikpijn]- Irritable Bowel Syndrome (IBS) [prikkelbaar darmsyndroom (PDS)]- Fuctional dyspepsia [functionele dyspepsie]- Abdominal migraine (abdominale migraine)
- Registration Number
- NL-OMON24858
- Lead Sponsor
- - Emma Children's Hospital AMC (Amsterdam)- De Bascule, Academic Center for Child and Adolescent Psychiatry (Amsterdam)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1. Age 8-18;
2. Abdominal pain is main complaint;
Exclusion Criteria
1. Red flag signals in physical examination (localized tenderness in right upper or lower quadrant, spine or costovertebral angle tenderness, hepatomegaly or splenomegaly, oral ulcers, perianal fissures or fistula);
2. Alarm signals in history (involuntary weightloss, decelerated growth, late puberty, significant vomiting or diarrhea, loss of blood at defecation, unexplained fever, rash, arthritis, IBD in family);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Abdominal pain, as measured by the Abdominal Pain Index (API; Walker et al., 1997).<br /><br>2. Abdominal pain, as measured by 1 week diary cards, making use of the Facial Affect Scale (FAS; McGrath et al., 1996).
- Secondary Outcome Measures
Name Time Method 1. Anxiety and depression, measured by a structured interview (ADIS-C/P; Silverman et al., 1988);<br /><br>2. Anxious and depressive symptoms, measured by the Revised Child Anxiety and Depression Scale - short version (RCADS; Muris et al., 2002);<br /><br>3. Other somatic complaints, measured by the Children's Somatization Inventory (CSI; Walker & Garber, 1992, Ghys & Meesters, 1993);<br /><br>4. Functional impairments due to the abdominal pain, as measured by the Functional Disability Inventory (FDI; Walker & Greene, 1991);<br /><br>5. Quality of life, as measured by the Kidscreen-27 (The KIDSCREEN Group, 2004);<br /><br>6. School absence;<br /><br>7. Health care use.