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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
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Specific Phobia

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

First Posted
September 27, 2014
Last Updated
January 18, 2016
Sponsor
Karolinska Institutet
Collaborators
BUP Östersund
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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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