search
Back to results

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

Primary Purpose

Abdominal Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
DARWeb
Sponsored by
Universitat Oberta de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Pain focused on measuring Online Intervention, Recurrent Abdominal Pain, Children

Eligibility Criteria

9 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universitat Oberta de Catalunya

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Participants in this arm will follow DARWeb: an online psychosocial intervention for children with recurrent abdominal pain and their parents. This is composed by 7 units for parents and 7 units for children, that have been developed from the cognitive-behavioral model, including setting goals, relaxation and distraction techniques, changing maladaptive thoughts and assertive communication training. The team under the program only contact with families for sending reminders and to answer potential technical problems or doubts

Participants allocated in this arm will not receive intervention. However, they will be invited to participate once the families allocated to the experimental group complete the program.

Outcomes

Primary Outcome Measures

Pain Intensity
Assessed with the abdominal Pain Index
Pain Frequency
Assessed with the abdominal Pain Index
Pain Intensity
Assessed with the abdominal Pain Index
Pain Intensity
Assessed with the abdominal Pain Index
Pain Frequency
Assessed with the abdominal Pain Index
Pain Frequency
Assessed with the abdominal Pain Index

Secondary Outcome Measures

Quality of life
Assessed with the Pediatric Quality of Life Inventory
Disability
Assessed with the Functional Disability Inventory
Depression
Assessed with the Children Depression Inventory.

Full Information

First Posted
January 28, 2016
Last Updated
April 23, 2019
Sponsor
Universitat Oberta de Catalunya
Collaborators
Ministerio de Economía y Competitividad, Spain
search

1. Study Identification

Unique Protocol Identification Number
NCT02676232
Brief Title
DARWeb: an Online Psychosocial Intervention for Children With Recurrent Abdominal Pain and Their Families.
Official Title
DARWeb: an Online Psychosocial Intervention for Children With Recurrent Abdominal Pain and Their Families.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Oberta de Catalunya
Collaborators
Ministerio de Economía y Competitividad, Spain

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain
Keywords
Online Intervention, Recurrent Abdominal Pain, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants in this arm will follow DARWeb: an online psychosocial intervention for children with recurrent abdominal pain and their parents. This is composed by 7 units for parents and 7 units for children, that have been developed from the cognitive-behavioral model, including setting goals, relaxation and distraction techniques, changing maladaptive thoughts and assertive communication training. The team under the program only contact with families for sending reminders and to answer potential technical problems or doubts
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants allocated in this arm will not receive intervention. However, they will be invited to participate once the families allocated to the experimental group complete the program.
Intervention Type
Behavioral
Intervention Name(s)
DARWeb
Intervention Description
Psychosocial Intervention from the cognitive-behavioral model, including different but related units for parents and children with recurrent abdominal pain.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Assessed with the abdominal Pain Index
Time Frame
2 weeks after intervention
Title
Pain Frequency
Description
Assessed with the abdominal Pain Index
Time Frame
2 weeks after intervention
Title
Pain Intensity
Description
Assessed with the abdominal Pain Index
Time Frame
6 months after the intervention
Title
Pain Intensity
Description
Assessed with the abdominal Pain Index
Time Frame
12 months after the intervention
Title
Pain Frequency
Description
Assessed with the abdominal Pain Index
Time Frame
6 months after the intervention
Title
Pain Frequency
Description
Assessed with the abdominal Pain Index
Time Frame
12 months after the intervention
Secondary Outcome Measure Information:
Title
Quality of life
Description
Assessed with the Pediatric Quality of Life Inventory
Time Frame
2 weeks after intervention; 6 and 12 months.
Title
Disability
Description
Assessed with the Functional Disability Inventory
Time Frame
2 weeks after intervention; 6 and 12 months.
Title
Depression
Description
Assessed with the Children Depression Inventory.
Time Frame
2 weeks after intervention; 6 and 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubén Nieto, PhD
Organizational Affiliation
Universitat Oberta de Catalunya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitat Oberta de Catalunya
City
Barcelona
ZIP/Postal Code
08018
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25551478
Citation
Nieto R, Hernandez E, Boixados 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.
Results Reference
background
Links:
URL
http://psinet.uoc.edu/courses/darweb/?lang=en
Description
Research team website

Learn more about this trial

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

We'll reach out to this number within 24 hrs