Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting

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.

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder; Specific Phobia; Separation Anxiety
• Intervention / Treatment: Behavioral: Internet-delivered Cognitive Behavior Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Jämtland
    • Östersund, Jämtland, Sweden, 83183
      • Child and Adolescent Mental Health Services Östersund

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional; Behavioral: Internet-delivered Cognitive Behavior Therapy	Behavioral: Internet-delivered Cognitive Behavior Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinical Global Impressions - severity (CGI-S)	Change in CGI-s from baseline to post-treatment and follow-up	baseline, post-treatment (12 weeks), follow-up (3 months)

Secondary Outcome Measures

Outcome Measure	Time Frame
Children´s Global Assessment Scale (CGAS	Baseline, post-treatment (12 weeks), follow-up (3 months)
Spence Child Anxiety Scale C/P (SCAS-C/P)	Baseline, post-treatment (12 weeks), follow-up (3 months)
Penn State Worry Questionnaire (PSWQ)	Baseline, post-treatment (12 weeks), follow-up (3 months)
Separation Anxiety Index (SAI)	Baseline, post-treatment (12 weeks), follow-up (3 months)
Fear Survey Schedule for Children - Revised (FSSC-R)	Baseline, post-treatment (12 weeks), follow-up (3 months)
Child Sheehan Disability Scale (CSDS)	Baseline, post-treatment (12 weeks), follow-up (3 months)
Child Depression Inventory (CDI)	Baseline, post-treatment (12 weeks), follow-up (3 months)
Hospital Anxiety Depression Scale (HAD)	Baseline, post-treatment (12 weeks), follow-up (3 months)
Client Satisfaction Scale (CSS)	post-treatment (12 weeks)
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)	Baseline, post-treatment (12 weeks), follow-up (3 months)

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: BUP Östersund

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: September 27, 2014
• First Submitted That Met QC Criteria: December 2, 2014
• First Posted (Estimate): December 3, 2014

Study Record Updates

• Last Update Posted (Estimate): January 20, 2016
• Last Update Submitted That Met QC Criteria: January 18, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Anxiety Disorders; Anxiety, Separation
• Other Study ID Numbers: 2014/1225-31/4