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Treatment of Anxiety Disorders for Children and Adolescents in Regular Outpatient Clinics (TADCAROC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02218996
Recruitment Status : Active, not recruiting
First Posted : August 18, 2014
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
Helse Vest
Information provided by (Responsible Party):
Helse Stavanger HF

Brief 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.

Condition or disease Intervention/treatment
Anxiety Disorders Other: Psychosocial treatment

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Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Treatment of Anxiety Disorders for Children and Adolescents in Regular Outpatient Clinics (TADCAROC)
Actual Study Start Date : August 2014
Estimated Primary Completion Date : December 31, 2028
Estimated Study Completion Date : December 31, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Group/Cohort Intervention/treatment
Psychosocial treatment
Children and adolescents with anxiety disorders
Other: Psychosocial treatment
Regular psychosocial treatment in clinical outpatient service.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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). ]
  2. 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). ]
  3. 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). ]
  4. 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) ]
  5. 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) ]
  6. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218996


Locations
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Norway
BUPA Helse Stavanger
Stavanger, Rogaland, Norway, 4011
Sponsors and Collaborators
Helse Stavanger HF
Helse Vest
Investigators
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Principal Investigator: Jon F Bjaastad, D. Psych Division of Psychiatry, Stavanger University Hospital, N-4068 Stavanger, Norway
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Responsible Party: Helse Stavanger HF
ClinicalTrials.gov Identifier: NCT02218996    
Other Study ID Numbers: ID416
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Helse Stavanger HF:
Anxiety
Children
Adolescent
Effectiveness
Outpatient
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders