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

Not Applicable

Completed

• Conditions: Generalized Anxiety Disorder; Specific Phobia; Separation Anxiety
• Interventions: Behavioral: Internet-delivered Cognitive Behavior Therapy

• Registration Number: NCT02306356
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-27
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-03
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-18
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional	Internet-delivered Cognitive Behavior Therapy	Behavioral: Internet-delivered Cognitive Behavior Therapy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)
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)

Trial Locations

Locations (1)

Child and Adolescent Mental Health Services Östersund; 🇸🇪 Östersund, Jämtland, Sweden