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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 trea

Detailed Summary:
Sponsor: Universitat Oberta de Catalunya

Current Primary Outcome:

• Pain Intensity [ Time Frame: 2 weeks after intervention ]
  Assessed with the abdominal Pain Index
• Pain Frequency [ Time Frame: 2 weeks after intervention ]
  Assessed with the abdominal Pain Index
• Pain Intensity [ Time Frame: 6 months after the intervention ]
  Assessed with the abdominal Pain Index
• Pain Intensity [ Time Frame: 12 months after the intervention ]
  Assessed with the abdominal Pain Index
• Pain Frequency [ Time Frame: 6 months after the intervention ]
  Assessed with the abdominal Pain Index
• Pain Frequency [ Time Frame: 12 months after the intervention ]
  Assessed with the abdominal Pain Index

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Quality of life [ Time Frame: 2 weeks after intervention; 6 and 12 months. ]
  Assessed with the Pediatric Quality of Life Inventory
• Disability [ Time Frame: 2 weeks after intervention; 6 and 12 months. ]
  Assessed with the Functional Disability Inventory
• Depression [ Time Frame: 2 weeks after intervention; 6 and 12 months. ]
  Assessed with the Children Depression Inventory.

Original Secondary Outcome: Same as current

Information By: Universitat Oberta de Catalunya

Dates:
Date Received: January 28, 2016
Date Started: September 2014
Date Completion: November 2017
Last Updated: May 1, 2017
Last Verified: May 2017