Clinical trial NCT00586586: Effectiveness Study of CBT for Anxiety in Children
Official title: Assessment and Treatment - Anxiety in Children and Adults (Child Part)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Separation Anxiety Disorder
Social Anxiety Disorder
Generalized Anxiety Disorder
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2008-01-04
Enrollment: 222
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Cognitive behaviour therapy (CBT) has been shown to be an efficacious treatment for anxiety disorders in youths when delivered in university settings. However, there is a lack of studies evaluating the effectiveness of CBT in regular clinical settings.

The current study will compare a CBT program developed for anxiety in youths (the FRIENDS program by Paula Barrett, Australia), with a wait-list control condition. Group and individual treatment will also be compared in the study. Groups will be divided by age, with younger including 8-12-year-olds, and older 12-15-year-olds. Parents are also involved at the end of all therapy sessions, as well as in separate parent sessions. Assessment and treatment is delivered by clinicians working in seven outpatient clinics in Western Norway.

There will be 10 therapy sessions, with booster sessions 4 and 12 weeks later. Effectiveness will be evaluated post-treatment, and at 1 and 5 years follow-up. The study will have a randomized design. Children randomized to the wait-list condition will be offered treatment if they still meet inclusion criteria after the waiting period.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Anxiety disorders according to the ADIS-IV C/P interview
timeFrame: Post-treatment and 1 and 5 year follow-up
Secondary outcomes:
measure: Anxiety symptom score according to the Spence Children Anxiety Scale
timeFrame: Post-treatment, 1 and 5 year follow-up
measure: Depressive symptoms according to the Mood and Feelings Questionnaire
timeFrame: Post-treatment, 1 and 5 year follow-up
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Einar Heiervang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haukeland University Hospital
name: Gro Janne H Wergeland, MD PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.