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

NCT02676232 | Completed

• 2 other identifiers: R464EPSI2013-42413-R
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Pain

Keywords

Online Intervention; Recurrent Abdominal Pain; Children

Outcome Measures

Primary Outcomes (6)

• Pain Intensity

  Assessed with the abdominal Pain Index

  2 weeks after intervention

• Pain Frequency

  Assessed with the abdominal Pain Index

  2 weeks after intervention

• Pain Intensity

  Assessed with the abdominal Pain Index

  6 months after the intervention

• Pain Intensity

  Assessed with the abdominal Pain Index

  12 months after the intervention

• Pain Frequency

  Assessed with the abdominal Pain Index

  6 months after the intervention

• Pain Frequency

  Assessed with the abdominal Pain Index

  12 months after the intervention

Secondary Outcomes (3)

• Quality of life

  2 weeks after intervention; 6 and 12 months.

• Disability

  2 weeks after intervention; 6 and 12 months.

• Depression

  2 weeks after intervention; 6 and 12 months.

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: DARWeb

Control

NO INTERVENTION

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.

Interventions

DARWeb BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 9 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• to 15 years
• Recurrent abdominal pain (abdominal pain at least once at month during a period of three months)
• Low level of disability

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Oberta de Catalunya: lead
• Ministerio de Economía y Competitividad, Spain: collaborator

Study Sites (1)

Universitat Oberta de Catalunya

Barcelona, 08018, Spain

Location

Related Publications (1)

• 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.

  PMID: 25551478 BACKGROUND

Related Links

• Research team website

MeSH Terms

Conditions

Abdominal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Rubén Nieto, PhD

  Universitat Oberta de Catalunya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rubén Nieto Luna, PhD

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 8, 2016
• Study Start: September 1, 2014
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: April 24, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)