NCT02873078

Brief Summary

This randomized controlled study aims to evaluate the efficacy of exposure-based Internet-delivered cognitive behavior therapy for children 8-12 years with Functional Abdominal Pain Disorders. The children participate along with their parents, who will also receive specific modules with information on how to support their children in the treatment. Predictors and mediators for treatment effects will be studied as well as the cost effectiveness of the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

1.4 years

First QC Date

August 9, 2016

Last Update Submit

September 14, 2020

Conditions

Functional Abdominal Pain Disorders

Outcome Measures

Primary Outcomes (1)

  • PedsQL Gastro

    Change in gastrointestinal symptoms measured with a self-rating scale from baseline to 10 weeks, from baseline to 9 months, and from baseline to 15 months for analysis of effect.

    Baseline to 10 weeks, baseline to 9 months, baseline to 15 months

Secondary Outcomes (41)

  • Faces Pain Rating Scale

    Baseline to 10 weeks, baseline to 9 months, baseline to 15 months

  • Faces Pain Rating Scale

    Weekly during treatment (treatment week 1-9).

  • Faces Pain Rating Scale rated by parents

    Baseline to 10 weeks, baseline to 9 months, baseline to 15 months

  • Faces Pain Rating Scale rated by parents

    Weekly during treatment (treatment week 1-9).

  • PedsQL Gastro rated by parents

    Baseline to 10 weeks, baseline to 9 months, baseline to 15 months

  • +36 more secondary outcomes

Study Arms (2)

Internet-delivered CBT

EXPERIMENTAL

Children and parents will receive 10 weekly modules of cognitive behavior therapy (CBT). Parents will also receive 10 weekly modules. Main components in the children's modules are exposure for abdominal symptoms, feared stimuli and situations in which the children are afraid of having symptoms. The parental receive information on how they can support their children in the treatment and how to reinforce health y behaviors and decrease attention to pain behaviors. Therapist support is provided through written messages within the secure platform.

Behavioral: Internet-delivered Cognitive behavior therapy

Waiting list

NO INTERVENTION

This is a wait-list control where the children and parents are allowed to carry on with any contacts within the health-care system, exempt for psychological treatments.

Interventions

Internet-delivered Cognitive behavior therapyBEHAVIORAL

The treatment is delivered via an online platform and is based on interventions for adults, adolescents and children tested in previous trials. Therapists are CBT-psychologists och students in clinical psychology under supervision.

Internet-delivered CBT

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children 8-12 years with either irritable bowel syndrome, functional dyspepsia or functional abdominal pain - not otherwise specified diagnosed according to Rome-III or Rome-IV criteria.
  • Psychopharmacological medication stable for at least a month if medicating.
  • Child and at least one parent speaking and writing swedish.
  • Access to computer with Internet connection.

You may not qualify if:

  • Severe somatic disorder and/or if the child fulfills criteria of other disorder that better explains the abdominal symptoms.
  • Severe psychiatric or social problems that needs other care.
  • Ongoing psychological treatment.
  • School absenteeism more than 40 %.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child and Adolescent Psychiatry in Stockholm

Stockholm, 11330, Sweden

Location

Related Publications (1)

  • Lalouni M, Ljotsson B, Bonnert M, Ssegonja R, Benninga M, Bjureberg J, Hogstrom J, Sahlin H, Simren M, Feldman I, Hedman-Lagerlof E, Serlachius E, Olen O. Clinical and Cost Effectiveness of Online Cognitive Behavioral Therapy in Children With Functional Abdominal Pain Disorders. Clin Gastroenterol Hepatol. 2019 Oct;17(11):2236-2244.e11. doi: 10.1016/j.cgh.2018.11.043. Epub 2018 Nov 28.

    PMID: 30502501DERIVED

Study Officials

  • Ola Olén, MD PhD

    Karolinska Institutet

    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
MD PhD

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 19, 2016

Study Start

August 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)