FRIENDS as an Indicative Prevention Program in Norway

NCT01802424 | Completed

• 1 other identifier: 71 FRIENDS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

Open trial; Indicative prevention; Youth anxiety; Cognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

The Friends program

EXPERIMENTAL

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

Interventions

The Friends program BEHAVIORAL

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.

The Friends program

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• NORCE Norwegian Research Centre AS: lead

Study Sites (1)

Fjell municipality

Bergen, Norway

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Bente SM Haugland, PhD

  Uni Research Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2013
• First Posted: March 1, 2013
• Study Start: February 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: December 7, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)