- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02218996
Treatment of Anxiety Disorders for Children and Adolescents in Regular Outpatient Clinics (TADCAROC)
May 15, 2023 updated by: Helse Stavanger HF
Treatment of Anxiety Disorders for Children and Adolescents in Regular Outpatient Clinics (TADCAROC)
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
260
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rogaland
-
Stavanger, Rogaland, Norway, 4011
- BUPA Helse Stavanger
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 17 years (Child)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Children/adolescents from 7-17 years old referred to ordinary outpatient mental health service.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Psychosocial treatment
Children and adolescents with anxiety disorders
|
Regular psychosocial treatment in clinical outpatient service.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Anxiety Disorder Interview Schedule for Diagnostic and Statistical Manual (DSM-IV), child and parent versions (ADIS- C/P; Silverman & Albano, 1996).
Time Frame: The primary outcome measure will be administered pre-treatment, post treatment (an expected average of 20 weeks) and at ten year follow-up.
|
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 Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Children's Anxiety Life Interference Scale (CALIS; Lyneham et al., 2013)
Time Frame: This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks).
|
This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks).
|
The Screen for Child Anxiety Related Emotional Disorders (SCARED; Birmaher et al., 1999).
Time Frame: This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks).
|
This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks).
|
Spence Children's Anxiety Scale (SCAS; Spence, 1998)
Time Frame: This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks).
|
This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks).
|
The Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997)
Time Frame: This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks)
|
This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks)
|
Short Mood & Feeling Questionaire (SMFQ; Angold et al., 1995).
Time Frame: This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks)
|
This outcome measure will be administered pre-treatment and post treatment (an expected average of 20 weeks)
|
Clinical Global Impressions (CGI; Guy, 1976).
Time Frame: The outcome measure will be administered pre-treatment, post treatment (an expected average of 20 weeks) and at ten year follow-up.
|
The outcome measure will be administered pre-treatment, post treatment (an expected average of 20 weeks) and at ten year follow-up.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jon F Bjaastad, D. Psych, Division of Psychiatry, Stavanger University Hospital, N-4068 Stavanger, Norway
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2014
Primary Completion (Anticipated)
December 31, 2028
Study Completion (Anticipated)
December 31, 2029
Study Registration Dates
First Submitted
August 8, 2014
First Submitted That Met QC Criteria
August 14, 2014
First Posted (Estimate)
August 18, 2014
Study Record Updates
Last Update Posted (Actual)
May 16, 2023
Last Update Submitted That Met QC Criteria
May 15, 2023
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID416
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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