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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02218996
Other study ID # ID416
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 2014
Est. completion date December 31, 2029

Study information

Verified date November 2022
Source Helse Stavanger HF
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to examine the content of the treatment being delivered for anxiety disorders for children and adolescents in the regular outpatient clinics in western Norway. The study will also collect data before and after treatment to evaluate the result of the treatment. Furthermore, as part of the study we aim to collect normative data on two questionnaires used to identify anxiety symptoms and the extent to which anxiety interfere with daily functioning. We also aim to develop a quality indicator for anxiety treatment that can be used to monitor treatment in the regular outpatient service, based on the results of the current study.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 260
Est. completion date December 31, 2029
Est. primary completion date December 31, 2028
Accepts healthy volunteers No
Gender All
Age group 7 Years to 17 Years
Eligibility Inclusion Criteria: - Clinical diagnosis of an anxiety disorder (including PTSD and OCD) based on the diagnostic interview ADIS (ADIS-C/P; Silverman & Albano, 1996). - The anxiety disorder is the patients primary diagnosis. - Informed concent is given. Exclusion Criteria: - The patient is in need for other primary treatment intervention (e.g., psychosis, suicidality risk)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Psychosocial treatment
Regular psychosocial treatment in clinical outpatient service.

Locations

Country Name City State
Norway BUPA Helse Stavanger Stavanger Rogaland

Sponsors (2)

Lead Sponsor Collaborator
Helse Stavanger HF Helse Vest

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Anxiety Disorder Interview Schedule for Diagnostic and Statistical Manual (DSM-IV), child and parent versions (ADIS- C/P; Silverman & Albano, 1996). Diagnostic interview for anxiety disorders and other comorbid disorders. For the 10-year follow-up we anticipate to use another version of the diagnostic interview schedule based on revised diagnostic criteria for anxiety disorders. The primary outcome measure will be administered pre-treatment, post treatment (an expected average of 20 weeks) and at ten year follow-up.
Secondary Children's Anxiety Life Interference Scale (CALIS; Lyneham et al., 2013) This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks).
Secondary The Screen for Child Anxiety Related Emotional Disorders (SCARED; Birmaher et al., 1999). This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks).
Secondary Spence Children's Anxiety Scale (SCAS; Spence, 1998) This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks).
Secondary The Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks)
Secondary Short Mood & Feeling Questionaire (SMFQ; Angold et al., 1995). This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks)
Secondary Clinical Global Impressions (CGI; Guy, 1976). The outcome measure will be administered pre-treatment, post treatment (an expected average of 20 weeks) and at ten year follow-up.
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