NCT02218996

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Aug 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Aug 2014Dec 2029

Study Start

First participant enrolled

August 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
14.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

14.4 years

First QC Date

August 8, 2014

Last Update Submit

December 17, 2024

Conditions

Keywords

AnxietyChildrenAdolescentEffectivenessOutpatient

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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)

  • +1 more secondary outcomes

Study Arms (1)

Psychosocial treatment

Children and adolescents with anxiety disorders

Other: Psychosocial treatment

Interventions

Regular psychosocial treatment in clinical outpatient service.

Psychosocial treatment

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children/adolescents from 7-17 years old referred to ordinary outpatient mental health service.

You may qualify if:

  • 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.

You may not qualify if:

  • The patient is in need for other primary treatment intervention (e.g., psychosis, suicidality risk)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BUPA Helse Stavanger

Stavanger, Rogaland, 4011, Norway

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Jon F Bjaastad, D. Psych

    Division of Psychiatry, Stavanger University Hospital, N-4068 Stavanger, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2014

First Posted

August 18, 2014

Study Start

August 1, 2014

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations