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FRIENDS as an Indicative Prevention Program in Norway

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ClinicalTrials.gov Identifier: NCT01802424
Recruitment Status : Completed
First Posted : March 1, 2013
Last Update Posted : December 7, 2015
Sponsor:
Information provided by (Responsible Party):
Uni Research

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.

Condition or disease Intervention/treatment Phase
Anxiety Behavioral: The Friends program Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The FRIENDS-program as Indicative Prevention for Children and Adolescents With Symptoms of Anxiety and Depression
Study Start Date : February 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   8 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01802424


Locations
Norway
Fjell municipality
Bergen, Norway
Sponsors and Collaborators
Uni Research
Investigators
Principal Investigator: Bente SM Haugland, PhD Uni Research Health

Responsible Party: Uni Research
ClinicalTrials.gov Identifier: NCT01802424     History of Changes
Other Study ID Numbers: 71 FRIENDS
First Posted: March 1, 2013    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Uni Research:
Open trial
Indicative prevention
Youth anxiety
Cognitive behavioral therapy

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders