FRIENDS as an Indicative Prevention Program in Norway

December 4, 2015 updated by: NORCE Norwegian Research Centre AS

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway
        • Fjell municipality

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The Friends program
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
When completing the intervention and 3months and 12 months after having completed the intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: When completing the intervention and 3months and 12 months after having completed the intervention
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
Time Frame: When completing the intervention and 3months and 12 months after having completed the intervention
When completing the intervention and 3months and 12 months after having completed the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NORCE Norwegian Research Centre AS

Investigators

  • Principal Investigator: Bente SM Haugland, PhD, Uni Research Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

February 21, 2013

First Submitted That Met QC Criteria

February 27, 2013

First Posted (Estimate)

March 1, 2013

Study Record Updates

Last Update Posted (Estimate)

December 7, 2015

Last Update Submitted That Met QC Criteria

December 4, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 71 FRIENDS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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