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FRIENDS as a Prevention Program in Schools in Norway

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Uni Research
Sponsor:
Information provided by (Responsible Party):
Uni Research
ClinicalTrials.gov Identifier:
NCT01802424
First received: February 21, 2013
Last updated: February 27, 2013
Last verified: February 2013
  Purpose

The purpose of this pilot-study is to evaluate a cognitive behavioral program, the Friends-program, as indicated prevention for anxious youth with or without symptoms of depression. The youth are recruited by school nurses who will also lead the intervention groups applying the Friends-manual developed by Paula Barrett. The study will furthermore also evaluate the Friends program as an universal prevention program used in ordinary school classes with school nurses and class-room teachers as Friends-leaders.


Condition Intervention
Anxiety
Behavioral: The Friends-program

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The FRIENDS-program as Universal and 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Changes in depressive symptoms (measured by SMFQ -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 ] [ Designated as safety issue: No ]
  • Changes in psychosocial functioning (measured by the SDQ- 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: February 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: The Friends program as indicative prevention interventions
In this groups youth with increased levels of anxiety (and depression) 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. 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.
Behavioral: The Friends-program
Experimental: The Friends-program as universal prevention in school classes
The Friends-program is here used with all children in 5 school classes, to increase their problem solving skills, to identify feelings and thoughts and to foster a positive class-climate
Behavioral: The Friends-program

  Eligibility

Ages Eligible for Study:   8 Years to 15 Years
Genders Eligible for Study:   Both
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, OCD, 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

Contacts
Contact: Bente Storm Mowatt Haugland, PhD +47 97582317 bente.haugland@uni.no
Contact: Anja Høie Rogde, Psychologist +47 95465773 anja.rogde@uni.no

Locations
Norway
Fjell municipality Recruiting
Bergen, Norway
Contact: Anja H Rogde, Psychologist    +47 95465773    anja.rogde@uni.no   
Contact: Bente SM Haugland, PhD    +47 97582317    bente.haugland@uni.no   
Principal Investigator: Bente SM Haugland, PhD         
Sponsors and Collaborators
Uni Research
  More Information

No publications provided

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: February 27, 2013
Health Authority: Norway: Regional Ethics Committee

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

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 25, 2014