FRIENDS as an Indicative Prevention Program in Norway

Anxiety Clinical Trial

Official title:

The FRIENDS-program as Indicative Prevention for Children and Adolescents With Symptoms of Anxiety and Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01802424
• Other study ID #: 71 FRIENDS
• Status: Completed
• Phase: N/A
• First received: February 21, 2013
• Last updated: December 4, 2015
• Start date: February 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2015
• Source: Uni Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

The purpose of this pilot-study is to evaluate a cognitive behavioral program, the Friends-program, as indicated prevention for anxious youth. The youths are recruited by school nurses who will also lead the intervention groups applying the Friends-manual.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 15 Years

Eligibility

Inclusion Criteria:

• subclinical to clinical symptoms of anxiety with or without comorbid symptoms of depression

Exclusion Criteria:

• previously diagnosed with conduct disorder, major life-crises that needs to be attended to, serious school refusal, Obsessive Compulsive Disorder, mental retardation or autism.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anxiety

Intervention

Behavioral:
• The Friends program
The Friends program is a ten weeks group interventions based on principles from Cognitive Behavioural Therapy aimed at ameliorating symptoms of anxiety and depression in children and adolescents. There are age-specific versions of the manual, one for children 8-12 years and one for adolescents 12-15 years.

Locations

Country	Name	City	State
Norway	Fjell municipality	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Uni Research

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anxiety symptoms from baseline to 12 months after completing the FRIENDS program, measured by the Spence Children Anxiety Scale (SCAS)		When completing the intervention and 3months and 12 months after having completed the intervention	No
Secondary	Changes in life-quality (measured by KINDL)from baseline to 12 months after completing the FRIENDS program		When completing the intervention and 3months and 12 months after having completed the intervention	No
Secondary	Changes in depressive symptoms (measured by the Short Mood and Feeling questionnaire)from baseline to 12 months after completing the FRIENDS program		When completing the intervention and 3months and 12 months after having completed the intervention	No
Secondary	Changes in psychosocial functioning (measured by the Strengths and difficulties questionnaire)from baseline until 12 months after having completed the FRIENDS program		When completing the intervention and 3months and 12 months after having completed the intervention	No