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

NCT02306356 | Completed

• 1 other identifier: 2014/1225-31/4
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Specific Phobia; Separation Anxiety; Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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)

Study Arms (1)

Interventional

EXPERIMENTAL

Behavioral: Internet-delivered Cognitive Behavior Therapy

Behavioral: Internet-delivered Cognitive Behavior Therapy

Interventions

Internet-delivered Cognitive Behavior Therapy BEHAVIORAL

Interventional

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• BUP Östersund: collaborator

Study Sites (1)

Child and Adolescent Mental Health Services Östersund

Östersund, Jämtland County, 83183, Sweden

Location

MeSH Terms

Conditions

Phobia, Specific; Anxiety, Separation; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Neurodevelopmental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: September 27, 2014
• First Posted: December 3, 2014
• Study Start: September 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

SE (1)