Clinical trial NCT02306356: 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
Overall status: COMPLETED
Phase: NA
Conditions: Specific Phobia
Separation Anxiety
Generalized Anxiety Disorder
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: BUP Östersund
First posted: 2014-12-03
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Clinical Global Impressions - severity (CGI-S)
timeFrame: baseline, post-treatment (12 weeks), follow-up (3 months)
Secondary outcomes:
measure: Children´s Global Assessment Scale (CGAS
timeFrame: Baseline, post-treatment (12 weeks), follow-up (3 months)
measure: Spence Child Anxiety Scale C/P (SCAS-C/P)
timeFrame: Baseline, post-treatment (12 weeks), follow-up (3 months)
measure: Penn State Worry Questionnaire (PSWQ)
timeFrame: Baseline, post-treatment (12 weeks), follow-up (3 months)
measure: Separation Anxiety Index (SAI)
timeFrame: Baseline, post-treatment (12 weeks), follow-up (3 months)
measure: Fear Survey Schedule for Children - Revised (FSSC-R)
timeFrame: Baseline, post-treatment (12 weeks), follow-up (3 months)
measure: Child Sheehan Disability Scale (CSDS)
timeFrame: Baseline, post-treatment (12 weeks), follow-up (3 months)
measure: Child Depression Inventory (CDI)
timeFrame: Baseline, post-treatment (12 weeks), follow-up (3 months)
measure: Hospital Anxiety Depression Scale (HAD)
timeFrame: Baseline, post-treatment (12 weeks), follow-up (3 months)
measure: Client Satisfaction Scale (CSS)
timeFrame: post-treatment (12 weeks)
measure: Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)
timeFrame: Baseline, post-treatment (12 weeks), follow-up (3 months)
Other outcomes:
Locations:
city: Östersund
country: Sweden
facility: Child and Adolescent Mental Health Services Östersund
state: Jämtland
Study officials:
References: