Internet-Delivered CBT for Children With Functional Abdominal Pain Disorders

Study Overview
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Brief Summary
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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.

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

Conditions
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Functional Abdominal Pain Disorders

Intervention / Treatment
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* Behavioral: Internet-delivered Cognitive behavior therapy


Participation Criteria
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Eligibility Criteria
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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 %.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-delivered CBT<br>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<br>* 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.<br>|
| No Intervention: Waiting list<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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). | 
| 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 | 
| 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). | 
| 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 | 
| 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). | 
| 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 | 
| 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 | 
| 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 | 
| 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) | 
| 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 | 
| 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) | 
| 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 | 
| 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) | 
| 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 | 
| 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) | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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) | 
| Client Satisfactory Questionnaire (CSQ) | Client satisfaction rated measured with a self-rating scale | At week 10 | 
| Client Satisfactory Questionnaire (CSQ) rated by parents | Client satisfaction rated measured with a self-rating scale | At week 10 | 
| Subjective Assessment Questionnaire (SAQ) | Subjective change in symptoms measured with a self-rating scale | At week 10 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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) | 
| 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 | 
| 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) | 
| 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 | 
| Adverse events (AE) | Adverse events during treatment measured with a self-rating scale by the parents. | At week 10 | 
| 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 | 
| The treatment credibility scale rated by parents. | Treatment credibility measured with a self-rating scale by the parents. | At week 2 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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) | 
| 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). |