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Functional abdominal pain (FAP) within the context of internalizing disorders in childhood; A randomized controlled cognitive-behavioural family intervention.

Functional abdominal pain (FAP) within the context of internalizing disorders in childhood; A randomized controlled cognitive-behavioural family intervention.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24858
Enrollment
100
Registered
2009-01-05
Start date
2007-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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)

Interventions

MC: In line with the current practice of pediatricians in treating children with FAP: supportive physician-patient relationship and empathy for the family with reassurance that no serious disease i
2. learning pain management techniques (relaxation, breathing, imagery, physical exercises)
3. discussing dysfunctional cognitions (learning helping thoughts in stead of catastrophizing thoughts) if applicable
4. changing parent’s dysfunctional behaviour, if applicable
5. changing children's dysfunctional behaviour, if applicable (f.i., school absence). The content of the modules are described in detail in a protocol ‘CBT for FAP’. During this period no outpatient

Sponsors

- Emma Children's Hospital AMC (Amsterdam) - De Bascule, Academic Center for Child and Adolescent Psychiatry (Amsterdam)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 8-18; 2. Abdominal pain is main complaint; 3. Abdominal pain is present at least three times a week, 15 minutes a day. On the Facial Affect Scale (McGrath, 1996) ranging from 1-9, it hurts at least a '5'; 4. At least 8 weeks of abdominal pain in the last twelve months; 5. Has to understand the Dutch language sufficiently to receive treatment and fill out questionnaires in Dutch; 6. Informed consent from both parent and child.

Exclusion criteria

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); 3. Abnormalities in laboratory tests in blood, urine or feces; 4. Abnormalities shown on ultrasound; 5. Patient has undergone a significant surgery that might explain the abdominal pain; 6. Patient has been treated for the abdominal pain by a psychologist, psychiatrist or hypnotherapist in the last six months; 7. Psychosis.

Design outcomes

Primary

MeasureTime frame
1. Abdominal pain, as measured by the Abdominal Pain Index (API; Walker et al., 1997). 2. Abdominal pain, as measured by 1 week diary cards, making use of the Facial Affect Scale (FAS; McGrath et al., 1996).

Secondary

MeasureTime frame
1. Anxiety and depression, measured by a structured interview (ADIS-C/P; Silverman et al., 1988); 2. Anxious and depressive symptoms, measured by the Revised Child Anxiety and Depression Scale - short version (RCADS; Muris et al., 2002); 3. Other somatic complaints, measured by the Children's Somatization Inventory (CSI; Walker & Garber, 1992, Ghys & Meesters, 1993); 4. Functional impairments due to the abdominal pain, as measured by the Functional Disability Inventory (FDI; Walker & Greene, 1991); 5. Quality of life, as measured by the Kidscreen-27 (The KIDSCREEN Group, 2004); 6. School absence; 7. Health care use.

Contacts

Public ContactS. Veek, van der

De Bascule, Secretary O&O&O, location MBD, PA2-225 P.O. Box 303

s.m.vanderveek@amc.uva.nl+31 20 5662230

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)