Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting
Primary Purpose
Specific Phobia, Separation Anxiety, Generalized Anxiety Disorder
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-delivered Cognitive Behavior Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Specific Phobia
Eligibility Criteria
Inclusion Criteria:
- 8-12 years of age
- Fulfilling diagnostic criteria for Generalized Anxiety Disorder (GAD), Separation anxiety, Specific phobia
- Ability to read and write Swedish
- Daily access to the internet
- A parent that is able to co-participate in the treatment
- Participants on psychotropic medication must have been on a stable dose for the last 3 months prior to baseline assessment
Exclusion Criteria:
- Diagnosed autism spectrum disorder or Attention-deficit/hyperactivity disorder (ADHD), or principal primary disorder other than GAD, Separation anxiety, Specific phobia
- Acute/severe psychiatric problems such as suicidal risk or severe depression
- Ongoing psychological treatment for anxiety disorders
- Ongoing child custody dispute or abuse in the family
Sites / Locations
- Child and Adolescent Mental Health Services Östersund
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interventional
Arm Description
Behavioral: Internet-delivered Cognitive Behavior Therapy
Outcomes
Primary Outcome Measures
Change in Clinical Global Impressions - severity (CGI-S)
Change in CGI-s from baseline to post-treatment and follow-up
Secondary Outcome Measures
Children´s Global Assessment Scale (CGAS
Spence Child Anxiety Scale C/P (SCAS-C/P)
Penn State Worry Questionnaire (PSWQ)
Separation Anxiety Index (SAI)
Fear Survey Schedule for Children - Revised (FSSC-R)
Child Sheehan Disability Scale (CSDS)
Child Depression Inventory (CDI)
Hospital Anxiety Depression Scale (HAD)
Client Satisfaction Scale (CSS)
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)
Full Information
NCT ID
NCT02306356
First Posted
September 27, 2014
Last Updated
January 18, 2016
Sponsor
Karolinska Institutet
Collaborators
BUP Östersund
1. Study Identification
Unique Protocol Identification Number
NCT02306356
Brief Title
Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting
Official Title
Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
BUP Östersund
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
An open trial will be conducted at the Child and Mental Health Service (CAMHS) unit in the rural county Jämtland in Sweden to test the feasibility and efficacy of Internet-delivered Cognitive Behavior Therapy (ICBT) for children with anxiety disorders in a clinical setting. 20 children with a principal diagnosis of Generalized Anxiety Disorder (GAD), separation anxiety, specific phobia and their parents will be recruited from the CAMHS-center in Östersund. They will receive 12 weeks of therapist-supported ICBT and will be assessed by clinician ratings and child- and parent-reports at baseline, post-treatment and 3 month follow-up. The primary outcome measures the Clinical Global Impressions - Severity scale (CGI-S). Secondary outcome measures include clinician rated global functioning, and child and parent-rated anxiety and functioning.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Specific Phobia, Separation Anxiety, Generalized Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional
Arm Type
Experimental
Arm Description
Behavioral: Internet-delivered Cognitive Behavior Therapy
Intervention Type
Behavioral
Intervention Name(s)
Internet-delivered Cognitive Behavior Therapy
Primary Outcome Measure Information:
Title
Change in Clinical Global Impressions - severity (CGI-S)
Description
Change in CGI-s from baseline to post-treatment and follow-up
Time Frame
baseline, post-treatment (12 weeks), follow-up (3 months)
Secondary Outcome Measure Information:
Title
Children´s Global Assessment Scale (CGAS
Time Frame
Baseline, post-treatment (12 weeks), follow-up (3 months)
Title
Spence Child Anxiety Scale C/P (SCAS-C/P)
Time Frame
Baseline, post-treatment (12 weeks), follow-up (3 months)
Title
Penn State Worry Questionnaire (PSWQ)
Time Frame
Baseline, post-treatment (12 weeks), follow-up (3 months)
Title
Separation Anxiety Index (SAI)
Time Frame
Baseline, post-treatment (12 weeks), follow-up (3 months)
Title
Fear Survey Schedule for Children - Revised (FSSC-R)
Time Frame
Baseline, post-treatment (12 weeks), follow-up (3 months)
Title
Child Sheehan Disability Scale (CSDS)
Time Frame
Baseline, post-treatment (12 weeks), follow-up (3 months)
Title
Child Depression Inventory (CDI)
Time Frame
Baseline, post-treatment (12 weeks), follow-up (3 months)
Title
Hospital Anxiety Depression Scale (HAD)
Time Frame
Baseline, post-treatment (12 weeks), follow-up (3 months)
Title
Client Satisfaction Scale (CSS)
Time Frame
post-treatment (12 weeks)
Title
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)
Time Frame
Baseline, post-treatment (12 weeks), follow-up (3 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
8-12 years of age
Fulfilling diagnostic criteria for Generalized Anxiety Disorder (GAD), Separation anxiety, Specific phobia
Ability to read and write Swedish
Daily access to the internet
A parent that is able to co-participate in the treatment
Participants on psychotropic medication must have been on a stable dose for the last 3 months prior to baseline assessment
Exclusion Criteria:
Diagnosed autism spectrum disorder or Attention-deficit/hyperactivity disorder (ADHD), or principal primary disorder other than GAD, Separation anxiety, Specific phobia
Acute/severe psychiatric problems such as suicidal risk or severe depression
Ongoing psychological treatment for anxiety disorders
Ongoing child custody dispute or abuse in the family
Facility Information:
Facility Name
Child and Adolescent Mental Health Services Östersund
City
Östersund
State/Province
Jämtland
ZIP/Postal Code
83183
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting
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