Clinical trial NCT02873078: Internet-Delivered CBT for Children With Functional Abdominal Pain Disorders
Official title: Internet-Delivered Cognitive Behavior Therapy for Children With Functional Abdominal Pain Disorders - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Abdominal Pain Disorders
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 91
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 %.

Primary outcomes:
measure: PedsQL Gastro
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
Secondary outcomes:
measure: Faces Pain Rating Scale
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
measure: Faces Pain Rating Scale
timeFrame: Weekly during treatment (treatment week 1-9).
measure: Faces Pain Rating Scale rated by parents
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
measure: Faces Pain Rating Scale rated by parents
timeFrame: Weekly during treatment (treatment week 1-9).
measure: PedsQL Gastro rated by parents
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
measure: PedsQL Gastro rated by parents
timeFrame: Weekly during treatment (treatment week 1-9).
measure: Pediatric quality of life inventory (PedsQL QOL)
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
measure: Pediatric quality of life inventory (PedsQL QOL) rated by parents
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
measure: Painfree days
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
measure: Painfree days
timeFrame: Weekly during treatment (treatment week 1-9)
measure: Painfree days rated by parents
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
measure: Painfree days rated by parents
timeFrame: Weekly during treatment (treatment week 1-9)
measure: IBS-Behavioral responses questionnaire (IBS-BRQ)
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
measure: IBS-Behavioral responses questionnaire (IBS-BRQ)
timeFrame: Weekly during treatment (treatment week 1-9)
measure: IBS-Behavioral responses questionnaire (IBS-BRQ) parental version
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
measure: IBS-Behavioral responses questionnaire (IBS-BRQ) parental version
timeFrame: Weekly during treatment (treatment week 1-9)
measure: Spence Children Anxiety Scale - short version (SCAS-S)
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
measure: Spence Children Anxiety Scale - short version (SCAS-S) rated by parents
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
measure: Child Depression Inventory - short version (CDI-S)
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
measure: Visceral Sensitivity Index
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
measure: Visceral Sensitivity Index
timeFrame: Weekly during treatment (treatment week 1-9)
measure: Client Satisfactory Questionnaire (CSQ)
timeFrame: At week 10
measure: Client Satisfactory Questionnaire (CSQ) rated by parents
timeFrame: At week 10
measure: Subjective Assessment Questionnaire (SAQ)
timeFrame: At week 10
measure: Subjective Assessment Questionnaire (SAQ) rated by parents
timeFrame: At week 10
measure: Rome-IV questionnaire
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
measure: Kidscreen
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
measure: School absenteeism rated by parents
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
measure: School absenteeism rated by parents
timeFrame: Weekly during treatment (treatment week 1-9)
measure: Pain Catastrophizing Scale, parental version (PCS-P)
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
measure: Pain Catastrophizing Scale, parental version (PCS-P)
timeFrame: Weekly during treatment (treatment week 1-9)
measure: Children´s Somatization Inventory (CSI 24) rated by parents
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
measure: Adverse events (AE)
timeFrame: At week 10
measure: Working Alliance Inventory (WAI) short version
timeFrame: At week 4
measure: The treatment credibility scale rated by parents.
timeFrame: At week 2
measure: Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) rated by parents
timeFrame: Baseline, at weeks 3, 7, 10 and at 9 months
measure: General health questionnaire (GHQ-12) rated by parents
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
measure: Generalised anxiety disorder assessment (GAD 7) rated by parents
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
measure: Adult responses to children's symptoms (ARCS) rated by parents
timeFrame: Baseline to 10 weeks, baseline to 9 months, baseline to 15 months
measure: Adult responses to children's symptoms (ARCS) rated by parents
timeFrame: Weekly during treatment (treatment week 1-9)
measure: PedsQL Gastro
timeFrame: Weekly during treatment (treatment week 1-9).
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Child and Adolescent Psychiatry in Stockholm
Study officials:
affiliation: Karolinska Institutet
name: Ola Olén, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.