NCT00586586

Brief Summary

The study aims to evaluate the effectiveness of a cognitive behaviour therapy program (FRIENDS) for anxiety disorders in children aged 8-15 years who have been referred to child and adolescent mental health clinics in Western Norway.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
222

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

December 21, 2007

Completed
12 days until next milestone

Study Start

First participant enrolled

January 2, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2008

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2014

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

4.4 years

First QC Date

December 21, 2007

Last Update Submit

August 7, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Anxiety disorders according to the ADIS-IV C/P interview

    Diagnostic recovery from inclusion diagnoses and reduction on the clinical severity scale.

    Post-treatment and 1 and 5 year follow-up

Secondary Outcomes (2)

  • Anxiety symptom score according to the Spence Children Anxiety Scale

    Post-treatment, 1 and 5 year follow-up

  • Depressive symptoms according to the Mood and Feelings Questionnaire

    Post-treatment, 1 and 5 year follow-up

Study Arms (3)

Group CBT

EXPERIMENTAL

The behavioral intervention FRIENDS (cognitive behavior therapy program developed by P. Barratt) delivered in groups of 4 to 8. 10 weekly sessions plus 2 booster sessions.

Behavioral: Cognitive behavioural therapy

Individual CBT

EXPERIMENTAL

The behavioral intervention FRIENDS (cognitive behavior therapy program developed by P. Barratt) delivered individually. 10 weekly sessions plus 2 booster sessions.

Behavioral: Cognitive behavioural therapy

Wait-list control

NO INTERVENTION

Wait-list control condition for 5 weeks after last child has been included.

Interventions

The FRIENDS program developed by Paula Barrett, 10 weekly sessions of 60-90 minutes, with two additional parent meetings, and booster sessions 4 and 12 weeks after treatment.

Also known as: FRIENDS
Group CBTIndividual CBT

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Meeting DSM-IV criteria for separation anxiety, social anxiety or generalized anxiety disorder based on the ADIS interview schedule

You may not qualify if:

  • Pervasive developmental disorders, Selective mutism, Mental retardation
  • Having severe obsessional/compulsive, conduct or language problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (5)

  • Wergeland GJ, Fjermestad KW, Marin CE, Haugland BS, Bjaastad JF, Oeding K, Bjelland I, Silverman WK, Ost LG, Havik OE, Heiervang ER. An effectiveness study of individual vs. group cognitive behavioral therapy for anxiety disorders in youth. Behav Res Ther. 2014 Jun;57:1-12. doi: 10.1016/j.brat.2014.03.007. Epub 2014 Mar 31.

  • Wergeland GJ, Fjermestad KW, Marin CE, Haugland BS, Silverman WK, Ost LG, Havik OE, Heiervang ER. Predictors of dropout from community clinic child CBT for anxiety disorders. J Anxiety Disord. 2015 Apr;31:1-10. doi: 10.1016/j.janxdis.2015.01.004. Epub 2015 Jan 22.

  • Wergeland GJ, Fjermestad KW, Marin CE, Bjelland I, Haugland BS, Silverman WK, Ost LG, Bjaastad JF, Oeding K, Havik OE, Heiervang ER. Predictors of treatment outcome in an effectiveness trial of cognitive behavioral therapy for children with anxiety disorders. Behav Res Ther. 2016 Jan;76:1-12. doi: 10.1016/j.brat.2015.11.001. Epub 2015 Nov 5.

  • Kodal A, Fjermestad K, Bjelland I, Gjestad R, Ost LG, Bjaastad JF, Haugland BSM, Havik OE, Heiervang E, Wergeland GJ. Long-term effectiveness of cognitive behavioral therapy for youth with anxiety disorders. J Anxiety Disord. 2018 Jan;53:58-67. doi: 10.1016/j.janxdis.2017.11.003. Epub 2017 Nov 26.

  • Fjermestad KW, Lerner MD, McLeod BD, Wergeland GJ, Heiervang ER, Silverman WK, Ost LG, De Los Reyes A, Havik OE, Haugland BS. Therapist-youth agreement on alliance change predicts long-term outcome in CBT for anxiety disorders. J Child Psychol Psychiatry. 2016 May;57(5):625-32. doi: 10.1111/jcpp.12485. Epub 2015 Dec 9.

MeSH Terms

Conditions

Anxiety, SeparationPhobia, SocialGeneralized Anxiety Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersNeurodevelopmental DisordersPhobic Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Einar Heiervang, MD

    Haukeland University Hospital

    PRINCIPAL INVESTIGATOR
  • Gro Janne H Wergeland, MD PhD

    Haukeland University Hospital

    STUDY CHAIR

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
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 4, 2008

Study Start

January 2, 2008

Primary Completion

June 1, 2012

Study Completion

March 21, 2014

Last Updated

August 8, 2017

Record last verified: 2017-08

Locations