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.

Study Overview

• Status: Completed
• Conditions: Abdominal Pain
• Intervention / Treatment: Behavioral: DARWeb

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08018
    • Universitat Oberta de Catalunya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; Psychosocial Intervention from the cognitive-behavioral model, including different but related units for parents and children with recurrent abdominal pain.
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Assessed with the Pediatric Quality of Life Inventory	2 weeks after intervention; 6 and 12 months.
Disability	Assessed with the Functional Disability Inventory	2 weeks after intervention; 6 and 12 months.
Depression	Assessed with the Children Depression Inventory.	2 weeks after intervention; 6 and 12 months.

Collaborators and Investigators

• Sponsor: Universitat Oberta de Catalunya
• Collaborators: Ministerio de Economía y Competitividad, Spain
• Investigators: Principal Investigator: Rubén Nieto, PhD, Universitat Oberta de Catalunya

Publications and helpful links

General Publications

• 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.

Helpful Links

• Research team website

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: January 28, 2016
• First Submitted That Met QC Criteria: February 3, 2016
• First Posted (Estimate): February 8, 2016

Study Record Updates

• Last Update Posted (Actual): April 24, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Children; Online Intervention; Recurrent Abdominal Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain
• Other Study ID Numbers: R464E; PSI2013-42413-R (Other Grant/Funding Number: Ministerio de Economía y Competitividad)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No