FRIENDS as an Indicative Prevention Program in Norway

Study Overview
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Brief Summary
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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.

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

Conditions
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Anxiety

Intervention / Treatment
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* Behavioral: The Friends program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Friends program<br>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. | Behavioral: The Friends program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open trial, Indicative prevention, Youth anxiety, Cognitive behavioral therapy