Functional Abdominal Pain Disorders
Conditions
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.
Interventions
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.
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No
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 %.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PedsQL Gastro | Baseline to 10 weeks, baseline to 9 months, baseline to 15 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Faces Pain Rating Scale rated by parents | Baseline to 10 weeks, baseline to 9 months, baseline to 15 months | 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. |
| PedsQL Gastro rated by parents | Baseline to 10 weeks, baseline to 9 months, baseline to 15 months | 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. |
| Pediatric quality of life inventory (PedsQL QOL) | Baseline to 10 weeks, baseline to 9 months, baseline to 15 months | 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. |
| Pediatric quality of life inventory (PedsQL QOL) rated by parents | Baseline to 10 weeks, baseline to 9 months, baseline to 15 months | 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. |
| Painfree days | Baseline to 10 weeks, baseline to 9 months, baseline to 15 months | 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. |
| Painfree days rated by parents | Baseline to 10 weeks, baseline to 9 months, baseline to 15 months | 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. |
| IBS-Behavioral responses questionnaire (IBS-BRQ) | Baseline to 10 weeks, baseline to 9 months, baseline to 15 months | 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. |
| Working Alliance Inventory (WAI) short version | At week 4 | Working alliance in first three weeks of treatment measured with a self-rating scale by the parents. |
| The treatment credibility scale rated by parents. | At week 2 | Treatment credibility measured with a self-rating scale by the parents. |
| Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) rated by parents | Baseline, at weeks 3, 7, 10 and at 9 months | Costs associated with the disorder measured with a self-rating scale by the parents. |
| IBS-Behavioral responses questionnaire (IBS-BRQ) parental version | Baseline to 10 weeks, baseline to 9 months, baseline to 15 months | 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. |
| Spence Children Anxiety Scale - short version (SCAS-S) | Baseline to 10 weeks, baseline to 9 months, baseline to 15 months | 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. |
| Spence Children Anxiety Scale - short version (SCAS-S) rated by parents | Baseline to 10 weeks, baseline to 9 months, baseline to 15 months | 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. |
| Child Depression Inventory - short version (CDI-S) | Baseline to 10 weeks, baseline to 9 months, baseline to 15 months | 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. |
| Faces Pain Rating Scale | Baseline to 10 weeks, baseline to 9 months, baseline to 15 months | 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. |
| Client Satisfactory Questionnaire (CSQ) | At week 10 | Client satisfaction rated measured with a self-rating scale |
| Client Satisfactory Questionnaire (CSQ) rated by parents | At week 10 | Client satisfaction rated measured with a self-rating scale |
| Subjective Assessment Questionnaire (SAQ) | At week 10 | Subjective change in symptoms measured with a self-rating scale |
| Subjective Assessment Questionnaire (SAQ) rated by parents | At week 10 | Subjective change in the child's symptoms measured with a self-rating scale by the parents. |
| Rome-IV questionnaire | Baseline to 10 weeks, baseline to 9 months, baseline to 15 months | 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. |
| Kidscreen | Baseline to 10 weeks, baseline to 9 months, baseline to 15 months | 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. |
| School absenteeism rated by parents | Baseline to 10 weeks, baseline to 9 months, baseline to 15 months | 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. |
| Pain Catastrophizing Scale, parental version (PCS-P) | Baseline to 10 weeks, baseline to 9 months, baseline to 15 months | 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. |
| Children´s Somatization Inventory (CSI 24) rated by parents | Baseline to 10 weeks, baseline to 9 months, baseline to 15 months | 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. |
| Adverse events (AE) | At week 10 | Adverse events during treatment measured with a self-rating scale by the parents. |
| General health questionnaire (GHQ-12) rated by parents | Baseline to 10 weeks, baseline to 9 months, baseline to 15 months | 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. |
| Generalised anxiety disorder assessment (GAD 7) rated by parents | Baseline to 10 weeks, baseline to 9 months, baseline to 15 months | 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. |
| Adult responses to children's symptoms (ARCS) rated by parents | Baseline to 10 weeks, baseline to 9 months, baseline to 15 months | 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. |
| PedsQL Gastro | Weekly during treatment (treatment week 1-9). | Change in gastrointestinal symptoms measured with a self-rating scale weekly during treatment for mediation analyses. |
| Visceral Sensitivity Index | Baseline to 10 weeks, baseline to 9 months, baseline to 15 months | 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. |
Countries
Sweden
Outcome results
None listed