Abdominal PainNCT02676232

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

A study testing DARWeb in people with Abdominal Pain, run by Universitat Oberta de Catalunya at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 9 to 15 years
Conditions the study is for: Abdominal Pain
What is being tested?: DARWeb
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 1 siteSpain
Study dates: Sep 2014to Mar 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 to 15 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Universitat Oberta de Catalunya
Barcelona, 08018

Other trials in Spain

About this study

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
Being tested: DARWeb
Keywords: Online Intervention, Recurrent Abdominal Pain, Children
Medical subject headings: Abdominal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02676232
Study group	Role	What they receive
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 Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Intensity
Assessed with the abdominal Pain Index
Measured: 2 weeks after intervention
Pain Frequency
Assessed with the abdominal Pain Index
Measured: 2 weeks after intervention
Pain Intensity
Assessed with the abdominal Pain Index
Measured: 6 months after the intervention
Pain Intensity
Assessed with the abdominal Pain Index
Measured: 12 months after the intervention
Pain Frequency
Assessed with the abdominal Pain Index
Measured: 6 months after the intervention
Pain Frequency
Assessed with the abdominal Pain Index
Measured: 12 months after the intervention

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Mar 2019

First posted8 Feb 2016 (estimated)
Study startSep 2014
Primary completionMar 2019
Study completionMar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Abdominal PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02676232
Sponsor's protocol ID: R464E
Other IDs: PSI2013-42413-R
Status last verified: Apr 2019
First submitted: 28 Jan 2016
Last updated: 24 Apr 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: No

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.
PubMed 25551478

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Abdominal Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: DARWeb: an Online Psychosocial Intervention for Children With Recurrent Abdominal Pain and Their Families.
ClinicalTrials.gov ID: NCT02676232
Acronym / sponsor ID: R464E
Conditions: Abdominal Pain
Keywords: Online Intervention, Recurrent Abdominal Pain, Children
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Universitat Oberta de CatalunyaUniversity, hospital or other
Collaborators: Ministerio de Economía y Competitividad, Spain
Study start: Sep 2014
Primary completion: Mar 2019 (actual)
Study completion: Mar 2019 (actual)
First posted: 8 Feb 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Chronic and recurrent pain is a very important issue in the society, and its treatment is challenging.

The investigators expect that their treatment program will be effective to reduce pain in the short, medium and long term.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Behavioral: DARWebParticipants 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
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.

Who may qualify

Ages: 9 to 15 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

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

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

3 secondary outcomes

Quality of life
Time frame: 2 weeks after intervention; 6 and 12 months.
Disability
Time frame: 2 weeks after intervention; 6 and 12 months.
Depression
Time frame: 2 weeks after intervention; 6 and 12 months.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
Background: PubMed 25551478Nieto 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.
Research team websiteLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Abdominal Pain

Recruiting
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RecruitingPhase 2
REctus Sheath Trial
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rubén Nieto, PhD principal investigator

Universitat Oberta de Catalunya

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing DARWeb in people with Abdominal Pain, run by Universitat Oberta de Catalunya at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity (time frame: 2 weeks after intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02676232, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.