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

Sponsor

Helse Stavanger HF (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02218996

Collaborator

Helse Vest (Other)

260

Enrollment

Location

185

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Anxiety Disorders	Other: Psychosocial treatment

Study Design

Study Type:

Observational

Anticipated 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 :

Aug 1, 2014

Anticipated Primary Completion Date :

Dec 31, 2028

Anticipated Study Completion Date :

Dec 31, 2029

Arms and Interventions

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

Arm

Intervention/Treatment

Psychosocial treatment

Children and adolescents with anxiety disorders

Other: Psychosocial treatment

Regular psychosocial treatment in clinical outpatient service.

Outcome Measures

Primary Outcome Measures

The Anxiety Disorder Interview Schedule for Diagnostic and Statistical Manual (DSM-IV), child and parent versions (ADIS- C/P; Silverman & Albano, 1996). [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

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).]
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).]
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).]
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)]
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)]
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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.