NCT00735995

Brief Summary

The purpose of this study is to assess the effectiveness of a cognitive-behavioral intervention for children aged 7 to 12 years with anxiety disorders who are referred to ordinary community clinics. The treatment will be conducted as individual therapy or group therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
165

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2008

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2008

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

5.2 years

First QC Date

August 13, 2008

Last Update Submit

September 24, 2018

Conditions

Separation Anxiety DisorderSocial PhobiaGeneralized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

  • Status of primary anxiety disorder at inclusion based on the ADIS interview schedule with parents and youth

    post-treatment and 2 year follow-up

Secondary Outcomes (2)

  • Symptom score on the MASC

    post-treatment and 2 year follow-up

  • CGAS

    post-treatment and 2 year follow-up

Study Arms (3)

A

EXPERIMENTAL

Individual CBT

Behavioral: Cognitive behavioral therapy (individual)

B

EXPERIMENTAL

Group CBT

Behavioral: Cognitive behavioral therapy (group)

C

NO INTERVENTION

Waiting-list control

Interventions

Cognitive behavioral therapy (individual)BEHAVIORAL

The Coping Cat program, 12 weekly sessions, two additional parent meetings

A
Cognitive behavioral therapy (group)BEHAVIORAL

The Coping Cat program, 12 weekly sessions, two additional parent meetings

B

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Primary diagnosis of separation anxiety disorder, social phobia or generalized anxiety disorder based on the ADIS interview schedule, DSM-IV criteria

You may not qualify if:

  • Pervasive Developmental Disorder
  • Psychotic symptoms
  • Intelligence score \< 70
  • Use of medications with anxiety reducing effects during treatment
  • Neither parent competent in Norwegian language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Akershus Universitetssykehus HF

Lorenskog, 1478, Norway

Location

Sykehuset Asker og Baerum, Baerum BUP

Rud, 1309, Norway

Location

Sykehus Telemark Helseforetak, Skien og Porsgrunn BUP

Skien, Norway

Location

Related Publications (6)

  • Gere MK, Hagen KA, Villabo MA, Arnberg K, Neumer SP, Torgersen S. Fathers' mental health as a protective factor in the relationship between maternal and child depressive symptoms. Depress Anxiety. 2013 Jan;30(1):31-8. doi: 10.1002/da.22010. Epub 2012 Oct 25.

    PMID: 23108976RESULT

  • Villabo MA, Cummings CM, Gere MK, Torgersen S, Kendall PC. Anxious youth in research and service clinics. J Anxiety Disord. 2013 Jan;27(1):16-24. doi: 10.1016/j.janxdis.2012.09.003. Epub 2012 Sep 25.

    PMID: 23257654RESULT

  • Villabø MA, Gere MK, Torgersen S, Arnberg K, Neumer SP, Kendall PC. Anxious self-statements in clinic-referred US and Norwegian anxiety-disordered youth. Cognitive Therapy and Research 37(4): 840-850, 2013.

    RESULT

  • Gere MK, Villabo MA, Torgersen S, Kendall PC. Overprotective parenting and child anxiety: the role of co-occurring child behavior problems. J Anxiety Disord. 2012 Aug;26(6):642-9. doi: 10.1016/j.janxdis.2012.04.003. Epub 2012 May 14.

    PMID: 22659077RESULT

  • Villabo M, Gere M, Torgersen S, March JS, Kendall PC. Diagnostic efficiency of the child and parent versions of the Multidimensional Anxiety Scale for Children. J Clin Child Adolesc Psychol. 2012;41(1):75-85. doi: 10.1080/15374416.2012.632350.

    PMID: 22233247RESULT

  • Villabo MA, Narayanan M, Compton SN, Kendall PC, Neumer SP. Cognitive-behavioral therapy for youth anxiety: An effectiveness evaluation in community practice. J Consult Clin Psychol. 2018 Sep;86(9):751-764. doi: 10.1037/ccp0000326.

    PMID: 30138014RESULT

MeSH Terms

Conditions

Anxiety, SeparationPhobia, SocialGeneralized Anxiety Disorder

Interventions

Cognitive Behavioral TherapyPopulation Groups

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersNeurodevelopmental DisordersPhobic Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesDemographyPopulation Characteristics

Study Officials

  • Simon-Peter Neumer, dr.philos

    Regionsenter for barn og unges psykiske helse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr. Simon-Peter Neumer

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 15, 2008

Study Start

August 1, 2008

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

September 26, 2018

Record last verified: 2018-09

Locations

NO(3)