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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02113605
Other study ID # FGID Child Pilot-0
Secondary ID
Status Completed
Phase N/A
First received April 1, 2014
Last updated December 1, 2015
Start date April 2014
Est. completion date November 2015

Study information

Verified date December 2015
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

The purpose of the trial is to develop a treatment protocol to be used in trials studying internet-delivered CBT for children with functional gastrointestinal disorders (FGID). The study size is not based on power calculations but the estimated sample necessary to develop a treatment protocol. This study will include 20-30 children with FGID and their parents who will be treated individually (face-to-face). The treatment consists of 10 weekly sessions of exposure-based CBT. The study uses a pre- post-design with no control group.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 12 Years
Eligibility Inclusion Criteria:

- Age between 8-12 years

- A diagnosis of a functional gastrointestinal disorder by a treating physician

Exclusion Criteria:

- Concurrent serious medical condition or gastrointestinal symptoms likely caused by an organic disorder.

- Psychiatric disorder more urgent to treat than the abdominal pain.

- On-going psychological treatment.

- Absence from school more than 40 %.

- Ongoing maltreatment, violence or severe parental psychiatric illness.

- Pronounced language or learning difficulties that hinder the child to benefit from the treatment.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Cognitive behavior therapy
Exposure-based cognitive behavior therapy in a 10 week face-to-face treatment

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
Other Change in Parental Behavior FGID (PB-FGID) from baseline to 10 weeks. Baseline and 10 weeks. No
Other Change in Parental Behavior FGID (PB-FGID) from baseline to 8 months. Baseline and 8 months. No
Other Change in Adult responses to children´s symptoms (ARCS) from baseline to 10 weeks. Baseline and 10 weeks. No
Other Change in Adult responses to children´s symptoms (ARCS) from baseline to 8 months. Baseline and 8 months. No
Primary Change in Faces Pain Rating Scale (FACES) from baseline to 10 weeks Baseline and 10 weeks No
Primary Change in Faces Pain Rating Scale (FACES) from baseline to 8 months. Baseline and 8 months. No
Secondary Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 10 weeks. Baseline and 10 weeks. No
Secondary Change in Children´s Somatization Inventory (CSI 24) from baseline to 10 weeks Baseline and 10 weeks. No
Secondary Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 10 weeks Baseline and 10 weeks. No
Secondary Change in Functional Disability Index (FDI) from baseline to 10 weeks. Baseline and 10 weeks. No
Secondary Change in Pain Reactivity Scale from baseline to 10 weeks. Baseline and 10 weeks. No
Secondary Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 10 weeks. Baseline and 10 weeks. No
Secondary Change in Spence Children Anxiety Scale (SCAS) from baseline to 10 weeks. Baseline and 10 weeks. No
Secondary Change in Child Depression Inventory (CDI) from baseline to 10 weeks. Baseline and 10 weeks. No
Secondary Change in Pain Interference Index (PII) from baseline to 10 weeks. Baseline and 10 weeks. No
Secondary Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 10 weeks. Baseline and 10 weeks. No
Secondary Change in Gastrointestinal Symptom Rating Scale (GSRS-IBS) from baseline to 8 months. Baseline and 8 months No
Secondary Change in Children´s Somatization Inventory (CSI 24) from baseline to 8 months Baseline and 8 months. No
Secondary Change in Gastrointestinal Symptom Scale (PedsQL Gastro) from baseline to 8 months. Baseline and 8 months. No
Secondary Change in Functional Disability Index (FDI) from baseline to 8 months. Baseline and 8 months. No
Secondary Change in IBS-behavioral responses questionnaires (IBS-BRQ) from baseline to 8 months. Baseline and 8 months. No
Secondary Change in Spence Children Anxiety Scale (SCAS) from baseline to 8 months. Baseline and 8 months. No
Secondary Change in Child Depression Inventory (CDI) from baseline to 8 months. Baseline and 8 months. No
Secondary Change in Pain Interference Index (PII) from baseline to 8 months. Baseline and 8 months. No
Secondary Change in Pediatric Quality of Life Inventory (Peds QL) from baseline to 8 months. Baseline and 8 months. No
Secondary Change in Pain Reactivity Scale from baseline to 8 months. Baseline and 8 months. No
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