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FRIENDS as an Indicative Prevention Program in Norway

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Uni Research
ClinicalTrials.gov Identifier:
NCT01802424
First received: February 21, 2013
Last updated: December 4, 2015
Last verified: December 2015
  Purpose
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 Intervention
Anxiety Behavioral: The Friends program

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The FRIENDS-program as Indicative Prevention for Children and Adolescents With Symptoms of Anxiety and Depression

Resource links provided by NLM:


Further study details as provided by Uni Research:

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) [ Time Frame: When completing the intervention and 3months and 12 months after having completed the intervention ]

Secondary Outcome Measures:
  • 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 ]
  • 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 ]
  • 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 ]

Enrollment: 80
Study Start Date: February 2012
Study Completion Date: December 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802424

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

Responsible Party: Uni Research
ClinicalTrials.gov Identifier: NCT01802424     History of Changes
Other Study ID Numbers: 71 FRIENDS
Study First Received: February 21, 2013
Last Updated: December 4, 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

ClinicalTrials.gov processed this record on July 21, 2017