Internet-Delivered CBT for Children With Functional Abdominal Pain Disorders

Functional Abdominal Pain Disorders Clinical Trial

Official title:

Internet-Delivered Cognitive Behavior Therapy for Children With Functional Abdominal Pain Disorders - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02873078
• Other study ID #: RCT ICBT FAPD
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: January 2018

Study information

• Verified date: September 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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 %.

Related Conditions & MeSH terms

• Abdominal Pain
• Functional Abdominal Pain Disorders
• Somatoform Disorders

Intervention

Behavioral:
• Internet-delivered Cognitive behavior therapy
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.

Locations

Country	Name	City	State
Sweden	Child and Adolescent Psychiatry in Stockholm	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Faces Pain Rating Scale	Change in pain intensity 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	Faces Pain Rating Scale	Change in pain intensity measured with a self-rating scale weekly during treatment for mediation analyses.	Weekly during treatment (treatment week 1-9).
Secondary	Faces Pain Rating Scale rated by parents	Change in child's pain intensity 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	Faces Pain Rating Scale rated by parents	Change in pain intensity measured with a self-rating scale weekly during treatment for mediation analyses.	Weekly during treatment (treatment week 1-9).
Secondary	PedsQL Gastro rated by parents	Change in child 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	PedsQL Gastro rated by parents	Change in child gastrointestinal symptoms measured with a self-rating scale weekly during treatment for mediation.	Weekly during treatment (treatment week 1-9).
Secondary	Pediatric quality of life inventory (PedsQL QOL)	Change in quality of life measured 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	Pediatric quality of life inventory (PedsQL QOL) rated by parents	Change in child quality of life 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	Painfree days	Change in pain free days 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	Painfree days	Change in pain free days measured with a self-rating scale weekly during treatment for mediation analyses.	Weekly during treatment (treatment week 1-9)
Secondary	Painfree days rated by parents	Change in child's pain free days 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	Painfree days rated by parents	Change in child's pain free days measured with a self-rating scale weekly during treatment for mediation analyses.	Weekly during treatment (treatment week 1-9)
Secondary	IBS-Behavioral responses questionnaire (IBS-BRQ)	Change in childs behavioral responses to abdominal 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	IBS-Behavioral responses questionnaire (IBS-BRQ)	Change in child's behavioral responses to abdominal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.	Weekly during treatment (treatment week 1-9)
Secondary	IBS-Behavioral responses questionnaire (IBS-BRQ) parental version	Change in child's behavioral responses to abdominal 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	IBS-Behavioral responses questionnaire (IBS-BRQ) parental version	Change in child's behavioral responses to abdominal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.	Weekly during treatment (treatment week 1-9)
Secondary	Spence Children Anxiety Scale - short version (SCAS-S)	Change in child's anxiety 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	Spence Children Anxiety Scale - short version (SCAS-S) rated by parents	Change in child's anxiety 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	Child Depression Inventory - short version (CDI-S)	Change in child's depressive 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	Visceral Sensitivity Index	Change in visceral sensitivity 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	Visceral Sensitivity Index	Change in visceral sensitivity measured with a self-rating scale weekly during treatment for mediation analyses.	Weekly during treatment (treatment week 1-9)
Secondary	Client Satisfactory Questionnaire (CSQ)	Client satisfaction rated measured with a self-rating scale	At week 10
Secondary	Client Satisfactory Questionnaire (CSQ) rated by parents	Client satisfaction rated measured with a self-rating scale	At week 10
Secondary	Subjective Assessment Questionnaire (SAQ)	Subjective change in symptoms measured with a self-rating scale	At week 10
Secondary	Subjective Assessment Questionnaire (SAQ) rated by parents	Subjective change in the child's symptoms measured with a self-rating scale by the parents.	At week 10
Secondary	Rome-IV questionnaire	Change in diagnostic status of functional abdominal pain disorder 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	Kidscreen	Change in quality of life for use in economic evaluation 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	School absenteeism rated by parents	Change in child's school absenteeism 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	School absenteeism rated by parents	Change in child's school absenteeism measured with a self-rating scale weekly during treatment for mediation analyses.	Weekly during treatment (treatment week 1-9)
Secondary	Pain Catastrophizing Scale, parental version (PCS-P)	Change in parental catastrophizing of the child's 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	Pain Catastrophizing Scale, parental version (PCS-P)	Change in parental catastrophizing of the child's symptoms measured with a self-rating scale weekly during treatment for mediation analyses.	Weekly during treatment (treatment week 1-9)
Secondary	Children´s Somatization Inventory (CSI 24) rated by parents	Change in child's somatization 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	Adverse events (AE)	Adverse events during treatment measured with a self-rating scale by the parents.	At week 10
Secondary	Working Alliance Inventory (WAI) short version	Working alliance in first three weeks of treatment measured with a self-rating scale by the parents.	At week 4
Secondary	The treatment credibility scale rated by parents.	Treatment credibility measured with a self-rating scale by the parents.	At week 2
Secondary	Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) rated by parents	Costs associated with the disorder measured with a self-rating scale by the parents.	Baseline, at weeks 3, 7, 10 and at 9 months
Secondary	General health questionnaire (GHQ-12) rated by parents	Change in general health 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	Generalised anxiety disorder assessment (GAD 7) rated by parents	Change in parental anxiety 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	Adult responses to children's symptoms (ARCS) rated by parents	Change in parental responses to child's 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	Adult responses to children's symptoms (ARCS) rated by parents	Change in parental responses to child's symptoms measured with a self-rating scale weekly during treatment for mediation analyses.	Weekly during treatment (treatment week 1-9)
Secondary	PedsQL Gastro	Change in gastrointestinal symptoms measured with a self-rating scale weekly during treatment for mediation analyses.	Weekly during treatment (treatment week 1-9).