Clinical trial NCT02676232: 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
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Pain
Keywords: Online Intervention
Recurrent Abdominal Pain
Children
Lead sponsor: Universitat Oberta de Catalunya
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2016-02-08
Enrollment: 61
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Pain Intensity
timeFrame: 2 weeks after intervention
measure: Pain Frequency
timeFrame: 2 weeks after intervention
measure: Pain Intensity
timeFrame: 6 months after the intervention
measure: Pain Intensity
timeFrame: 12 months after the intervention
measure: Pain Frequency
timeFrame: 6 months after the intervention
measure: Pain Frequency
timeFrame: 12 months after the intervention
Secondary outcomes:
measure: Quality of life
timeFrame: 2 weeks after intervention; 6 and 12 months.
measure: Disability
timeFrame: 2 weeks after intervention; 6 and 12 months.
measure: Depression
timeFrame: 2 weeks after intervention; 6 and 12 months.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Universitat Oberta de Catalunya
Study officials:
affiliation: Universitat Oberta de Catalunya
name: Rubén Nieto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.