DARWeb: an Online Psychosocial Intervention for Children With Recurrent Abdominal Pain and Their Families.

Abdominal Pain Clinical Trial

Official title:

DARWeb: an Online Psychosocial Intervention for Children With Recurrent Abdominal Pain and Their Families.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02676232
• Other study ID #: R464E
• Secondary ID: PSI2013-42413-R
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: March 2019

Study information

• Verified date: April 2019
• Source: Universitat Oberta de Catalunya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic and recurrent pain is a very important issue in the society, and its treatment is challenging.

In children, one of the most common pain problems is recurrent abdominal pain. This problem can affect up to 12% of the children population, and can interfere on daily activities of both children and parents. Recurrent abdominal pain in children is also associated with other health problems, and can be related to problems in adulthood. Unfortunately, the current health system does not have an effective treatment for these children and their families. This is why the investigators propose an online intervention, DARWeb, for people in this situation.

DARWeb provides an innovative solution using Information and Communication Technology to facilitate access. It is also innovative because it is directed towards secondary prevention, in contrast to the majority of current treatments available for pain problems that are focused in reducing the impact of pain when it is already severe. Thus, the objective of DARWeb is to provide information and teach strategies to children and their parents that help them to cope with pain and prevent pain interference in their daily lives (in the short, medium and long term).

With this project, the investigators plan, first, to create a new version of their treatment program (DARWeb V2) from the results of the pilot study. Second, the investigators will test the effects of DARWeb V2 through a randomized clinical trial with a large sample, and they will assess the short, medium and long term effects. In addition, the investigators want to study which of the variables that are addressed in their intervention are responsible for the potential changes observed.

The investigators expect that their treatment program will be effective to reduce pain in the short, medium and long term.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 15 Years

Eligibility

Inclusion Criteria:

• 9 to 15 years

• Recurrent abdominal pain (abdominal pain at least once at month during a period of three months)

• Low level of disability

Exclusion Criteria:

• Identifiable organic cause.

• Disability preventing them to follow an online intervention.

• Not having a computer with Internet access.

• Not being able to read in Spanish language.

Related Conditions & MeSH terms

• Abdominal Pain

Intervention

Behavioral:
• DARWeb
Psychosocial Intervention from the cognitive-behavioral model, including different but related units for parents and children with recurrent abdominal pain.

Locations

Country	Name	City	State
Spain	Universitat Oberta de Catalunya	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Universitat Oberta de Catalunya	Ministerio de Economía y Competitividad, Spain

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Nieto R, Hernández E, Boixadós M, Huguet A, Beneitez I, McGrath P. Testing the Feasibility of DARWeb: An Online Intervention for Children With Functional Abdominal Pain and Their Parents. Clin J Pain. 2015 Jun;31(6):493-503. doi: 10.1097/AJP.0000000000000199. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity	Assessed with the abdominal Pain Index	2 weeks after intervention
Primary	Pain Frequency	Assessed with the abdominal Pain Index	2 weeks after intervention
Primary	Pain Intensity	Assessed with the abdominal Pain Index	6 months after the intervention
Primary	Pain Intensity	Assessed with the abdominal Pain Index	12 months after the intervention
Primary	Pain Frequency	Assessed with the abdominal Pain Index	6 months after the intervention
Primary	Pain Frequency	Assessed with the abdominal Pain Index	12 months after the intervention
Secondary	Quality of life	Assessed with the Pediatric Quality of Life Inventory	2 weeks after intervention; 6 and 12 months.
Secondary	Disability	Assessed with the Functional Disability Inventory	2 weeks after intervention; 6 and 12 months.
Secondary	Depression	Assessed with the Children Depression Inventory.	2 weeks after intervention; 6 and 12 months.

External Links

•   Research team website