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Completed

NCT Number: NCT02676232

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

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.

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Key information

Age range

9 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitat Oberta de Catalunya

Barcelona, 08018, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DARWeb

Behavioral

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

Primary outcomes

  1. Pain Intensity

    Time frame: 2 weeks after intervention

    Assessed with the abdominal Pain Index

  2. Pain Frequency

    Time frame: 2 weeks after intervention

    Assessed with the abdominal Pain Index

  3. Pain Intensity

    Time frame: 6 months after the intervention

    Assessed with the abdominal Pain Index

  4. Pain Intensity

    Time frame: 12 months after the intervention

    Assessed with the abdominal Pain Index

  5. Pain Frequency

    Time frame: 6 months after the intervention

    Assessed with the abdominal Pain Index

  6. Pain Frequency

    Time frame: 12 months after the intervention

    Assessed with the abdominal Pain Index

Secondary outcomes

  1. Quality of life

    Time frame: 2 weeks after intervention; 6 and 12 months.

    Assessed with the Pediatric Quality of Life Inventory

  2. Disability

    Time frame: 2 weeks after intervention; 6 and 12 months.

    Assessed with the Functional Disability Inventory

  3. Depression

    Time frame: 2 weeks after intervention; 6 and 12 months.

    Assessed with the Children Depression Inventory.

Sponsors and collaborators

Lead sponsor

Universitat Oberta de Catalunya

Other

Collaborators

  • Ministerio de Economía y Competitividad, Spain

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Feb 8, 2016
Registry last updated
Apr 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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