Back to resultsFRIENDS as an Indicative Prevention Program in Norway
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
The Friends program
Sponsored by
About this trial
This is an interventional prevention trial for Anxiety focused on measuring Open trial, Indicative prevention, Youth anxiety, Cognitive behavioral therapy
Eligibility Criteria
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.
Sites / Locations
- Fjell municipality
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
The Friends program
Arm Description
Youth with increased levels of anxiety are thought to regulate their fear by recognizing bodily cues, learning relaxation, regulating thoughts and feelings and expose themselves to situations and objects that activate their anxiety.
Outcomes
Primary Outcome Measures
Change in anxiety symptoms from baseline to 12 months after completing the FRIENDS program, measured by the Spence Children Anxiety Scale (SCAS)
Secondary Outcome Measures
Changes in life-quality (measured by KINDL)from baseline to 12 months after completing the FRIENDS program
Changes in depressive symptoms (measured by the Short Mood and Feeling questionnaire)from baseline to 12 months after completing the FRIENDS program
Changes in psychosocial functioning (measured by the Strengths and difficulties questionnaire)from baseline until 12 months after having completed the FRIENDS program
Full Information
NCT ID
NCT01802424
First Posted
February 21, 2013
Last Updated
December 4, 2015
Sponsor
NORCE Norwegian Research Centre AS
1. Study Identification
Unique Protocol Identification Number
NCT01802424
Brief Title
FRIENDS as an Indicative Prevention Program in Norway
Official Title
The FRIENDS-program as Indicative Prevention for Children and Adolescents With Symptoms of Anxiety and Depression
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NORCE Norwegian Research Centre AS
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Open trial, Indicative prevention, Youth anxiety, Cognitive behavioral therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The Friends program
Arm Type
Experimental
Arm Description
Youth with increased levels of anxiety are thought to regulate their fear by recognizing bodily cues, learning relaxation, regulating thoughts and feelings and expose themselves to situations and objects that activate their anxiety.
Intervention Type
Behavioral
Intervention Name(s)
The Friends program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in anxiety symptoms from baseline to 12 months after completing the FRIENDS program, measured by the Spence Children Anxiety Scale (SCAS)
Time Frame
When completing the intervention and 3months and 12 months after having completed the intervention
Secondary Outcome Measure Information:
Title
Changes in life-quality (measured by KINDL)from baseline to 12 months after completing the FRIENDS program
Time Frame
When completing the intervention and 3months and 12 months after having completed the intervention
Title
Changes in depressive symptoms (measured by the Short Mood and Feeling questionnaire)from baseline to 12 months after completing the FRIENDS program
Time Frame
When completing the intervention and 3months and 12 months after having completed the intervention
Title
Changes in psychosocial functioning (measured by the Strengths and difficulties questionnaire)from baseline until 12 months after having completed the FRIENDS program
Time Frame
When completing the intervention and 3months and 12 months after having completed the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bente SM Haugland, PhD
Organizational Affiliation
Uni Research Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fjell municipality
City
Bergen
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
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FRIENDS as an Indicative Prevention Program in Norway
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