ID

23161

Description

Responsible Party: Petra Warschburger, Prof. Dr., University of Potsdam ClinicalTrials.gov Identifier: NCT02030392 History of Changes Other Study ID Numbers: WA1143/9-1 DRKS00005038 ( Registry Identifier: DRKS ) Study First Received: October 28, 2013 Last Updated: March 24, 2016 A Randomized-controlled Study of a Cognitive-behavioral Intervention for Children With Functional Abdominal Pain (Stop-FAP) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02030392

Link

https://clinicaltrials.gov/ct2/show/NCT02030392

Keywords

  1. 6/26/17 6/26/17 -
Uploaded on

June 26, 2017

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

EligibilityCognitive-behavioral Intervention for Children With Functional Abdominal Pain DRKS00005038 NCT02030392 DRKS00005038

EligibilityCognitive-behavioral Intervention for Children With Functional Abdominal Pain NCT02030392 DRKS00005038

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Inclusion criteria for medical screening: Aged 7-12 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Inclusion criteria for medical screening: Abdominal pain for at least 2 months
Description

Abdominal Pain: Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0000737
UMLS CUI [1,2]
C0449238
Inclusion criteria for medical screening: Abdominal pain at least once per week
Description

Abdominal Pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0000737
UMLS CUI [1,2]
C0439603
Inclusion criteria for medical screening: Unclear cause for abdominal pain
Description

Abdominal Pain: Cause

Data type

boolean

Alias
UMLS CUI [1,1]
C0000737
UMLS CUI [1,2]
C0015127
Inclusion Criteria for study participation: Pain-predominant functional gastrointestinal disorders according to Rome-III
Description

Rome III classification

Data type

boolean

Alias
UMLS CUI [1]
C4062680
Inclusion Criteria for study participation: Criteria (H2a, H2b, H2d, H2d1)
Description

Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0242801
Inclusion Criteria for study participation: Informed consent for study particiaption
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Inclusion Criteria for study participation: Informed consent for audiotaping of trainings sessions
Description

Informed Consent for Audiotaping

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0004295
Inclusion Criteria for study participation: No time constraints for participation in training groups
Description

Time for Treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0087111
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Exclusion criteria for medical screening: Very limited German language skills
Description

Language Ability

Data type

boolean

Alias
UMLS CUI [1]
C1145677
Exclusion criteria for medical screening: Mental retardation
Description

Mental retardation

Data type

boolean

Alias
UMLS CUI [1]
C0025362
Exclusion criteria for medical screening: Adjuvant psychological treatment at point of medical screening
Description

Psychological treatment

Data type

boolean

Alias
UMLS CUI [1]
C0841584
Exclusion criteria for medical screening: Participation in a trainingsprogram for abdominal pain in the 6 months prior to medical screening
Description

Training Program for Abdominal Pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0040607
UMLS CUI [1,2]
C0000737
Exclusion criteria for medical screening: Participation in a clinical trial which possibly may have effects on abdominal pain in the 4 weeks prior to medical screening
Description

Study Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
Exclusion criteria for medical screening: At point of medical screening: therapy or medication for abdominal pain
Description

Treatment for abdominal pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0000737
Exclusion criteria for medical screening Presentation of sibling aged 7-12 years
Description

Sibling

Data type

boolean

Alias
UMLS CUI [1]
C0037047
Exclusion Criteria for study participation: Psychiatric disorder (internalizing) with primary treatment indication
Description

Mental Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0004936
Exclusion Criteria for study participation: Severe externalizing disorder
Description

Externalizing disorder

Data type

boolean

Alias
UMLS CUI [1]
C4055048

Similar models

EligibilityCognitive-behavioral Intervention for Children With Functional Abdominal Pain NCT02030392 DRKS00005038

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
Inclusion criteria for medical screening: Aged 7-12 years
boolean
C0001779 (UMLS CUI [1])
Abdominal Pain: Duration
Item
Inclusion criteria for medical screening: Abdominal pain for at least 2 months
boolean
C0000737 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Abdominal Pain
Item
Inclusion criteria for medical screening: Abdominal pain at least once per week
boolean
C0000737 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
Abdominal Pain: Cause
Item
Inclusion criteria for medical screening: Unclear cause for abdominal pain
boolean
C0000737 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Rome III classification
Item
Inclusion Criteria for study participation: Pain-predominant functional gastrointestinal disorders according to Rome-III
boolean
C4062680 (UMLS CUI [1])
Criteria
Item
Inclusion Criteria for study participation: Criteria (H2a, H2b, H2d, H2d1)
boolean
C0242801 (UMLS CUI [1])
Informed Consent
Item
Inclusion Criteria for study participation: Informed consent for study particiaption
boolean
C0021430 (UMLS CUI [1])
Informed Consent for Audiotaping
Item
Inclusion Criteria for study participation: Informed consent for audiotaping of trainings sessions
boolean
C0021430 (UMLS CUI [1,1])
C0004295 (UMLS CUI [1,2])
Time for Treatment
Item
Inclusion Criteria for study participation: No time constraints for participation in training groups
boolean
C0040223 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Language Ability
Item
Exclusion criteria for medical screening: Very limited German language skills
boolean
C1145677 (UMLS CUI [1])
Mental retardation
Item
Exclusion criteria for medical screening: Mental retardation
boolean
C0025362 (UMLS CUI [1])
Psychological treatment
Item
Exclusion criteria for medical screening: Adjuvant psychological treatment at point of medical screening
boolean
C0841584 (UMLS CUI [1])
Training Program for Abdominal Pain
Item
Exclusion criteria for medical screening: Participation in a trainingsprogram for abdominal pain in the 6 months prior to medical screening
boolean
C0040607 (UMLS CUI [1,1])
C0000737 (UMLS CUI [1,2])
Study Participation Status
Item
Exclusion criteria for medical screening: Participation in a clinical trial which possibly may have effects on abdominal pain in the 4 weeks prior to medical screening
boolean
C2348568 (UMLS CUI [1])
Treatment for abdominal pain
Item
Exclusion criteria for medical screening: At point of medical screening: therapy or medication for abdominal pain
boolean
C0087111 (UMLS CUI [1,1])
C0000737 (UMLS CUI [1,2])
Sibling
Item
Exclusion criteria for medical screening Presentation of sibling aged 7-12 years
boolean
C0037047 (UMLS CUI [1])
Mental Disorder
Item
Exclusion Criteria for study participation: Psychiatric disorder (internalizing) with primary treatment indication
boolean
C0004936 (UMLS CUI [1])
Externalizing disorder
Item
Exclusion Criteria for study participation: Severe externalizing disorder
boolean
C4055048 (UMLS CUI [1])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial