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School-based Universal Prevention for Anxiety and Depression in Sweden: A Cluster-randomized Trial

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
FRIENDS for life
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety Disorders focused on measuring FRIENDS for life, universal prevention, school children, anxiety

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Written parental consent

Exclusion Criteria:

  • No other exclusion criteria since of universal prevention

Sites / Locations

  • Department of Psychology, Uppsala University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Wait list

FRIENDS for life

Arm Description

Schools in waitlist condition will be offered the intervention after the 12-months follow up. Waitlist means that the schools work as usual with issues of mental health.

The intervention is delivered for 10 consecutive weeks, 60 minutes per session.

Outcomes

Primary Outcome Measures

Change in SCAS (Spence Children's Anxiety Scale)
Additional assessments using a short version of the SCAS (12 items out of 44) are made at two occasions during intervention (october and november 2013)

Secondary Outcome Measures

The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)
Change in Children's Depression Inventory (CDI)
Change in Strengths and Difficulties Questionnaire (SDQ)
SDQ is rated by participants' parents and teachers

Full Information

First Posted
April 15, 2014
Last Updated
January 29, 2015
Sponsor
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT02134730
Brief Title
School-based Universal Prevention for Anxiety and Depression in Sweden: A Cluster-randomized Trial
Official Title
School-based Universal Prevention for Anxiety and Depression in Sweden: A Cluster-randomized Trial Using the FRIENDS for Life Manual
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Mental illness is a major health problem in children and young people, and there is evidence that mental illness is increasing among young people in the population. More than 80 % of the cost to society of mental illness in children in Sweden is the cost of treatment and care. Anxiety and depression are the most common psychiatric problems in children and adolescents. In comparison with the treatment of mental disorders, there is relatively limited knowledge about prevention. There are at least two very important reasons to investigate further preventive interventions for anxiety and depression. (1) Only about 20% of children and adolescents with anxiety or depression use health services. (2) Some children stop treatment and almost 40% do still fulfill criteria for the disorder after treatment. FRIENDS for life is one of the most evaluated prevention programs internationally. The program has shown promising results in research. The overall aim of the present study is to evaluate FRIENDS for Life in Sweden.
Detailed Description
Mental illness is a major health problem in children and young people, and there is evidence that mental illness is increasing among young people in the population. More than 80 % of the cost to society of mental illness in children in Sweden is the cost of treatment and care. Only a small portion thus consists of preventive interventions. The report "Programs to prevent mental illness in children - a systematic literature review" (2010) from the Swedish National Council on Technology Assessment (SBU), concluded that no prevention program has evidence of efficacy under Swedish conditions. A target for future prevention work is according to the authors SBU-report that programs that are used have scientific support and evaluated in Sweden. Based on the review the report's authors recommend that five programs should be prioritized for further evaluation. One of these five programs is FRIENDS for life, a prevention program to prevent anxiety. Anxiety and depression are the most common psychiatric problems in children and adolescents. Untreated anxiety disorders often have a chronic course or may occur again and depression in adolescents often continue into adulthood anxiety and depression in children and adolescents predicts a variety of psychiatric diagnoses later in life, leading to difficulties with school and friends, and lead to increased risk of suicidal acts, alcohol and drug abuse. In comparison with the treatment of mental disorders, there is relatively limited knowledge about prevention. There are at least two very important reasons to investigate further preventive interventions for anxiety and depression. (1) Only about 20% of children and adolescents with anxiety or depression use health services. (2) Some children stop treatment and almost 40% do still fulfill criteria for the disorder after treatment. FRIENDS for life is one of the most evaluated prevention programs internationally. The program has shown promising results in research. In Sweden there are no high-quality evaluation of prevention programs targeting anxiety and depression. Based on the high incidence of anxiety and depression and its serious consequences it is of utmost importance to investigate whether prevention programs work in a Swedish context. The overall aim of the present study is to evaluate FRIENDS for Life in Sweden. The following research questions guide the study: Do FRIEND for life affect children's estimates of anxiety and depression symptoms and parents' estimates of children's anxiety symptoms, on the scales Spence Children's Anxiety Scale? Is the possible impact still visible after 12 months? Do FRIEND for life affect the presence of anxiety diagnoses and subclinical anxiety at 12 months according to ADIS-C/P interview? Additional research questions are: Is there any congruence between parents' and children's estimates of the child's anxiety symptoms? Do FRIEND for life affect parents' and teachers' estimates of children's general mental health? Do gender, symptom level, fidelity to the manual, decreased negative thoughts, behavioral inhibition affect the effect of FRIEND for life? International studies have shown promising results of FRIEND for life. Previous studies have, however, been of varying quality. Strengths of this study are that parents, teachers and children are respondents, and it is investigated whether various background characteristics and implementation factors influence the effect. Given the high prevalence of anxiety and depression in young ages, and the fact that only a few children with anxiety and depression use health services, the knowledge that this study generates are very important.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
FRIENDS for life, universal prevention, school children, anxiety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
695 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wait list
Arm Type
No Intervention
Arm Description
Schools in waitlist condition will be offered the intervention after the 12-months follow up. Waitlist means that the schools work as usual with issues of mental health.
Arm Title
FRIENDS for life
Arm Type
Experimental
Arm Description
The intervention is delivered for 10 consecutive weeks, 60 minutes per session.
Intervention Type
Behavioral
Intervention Name(s)
FRIENDS for life
Intervention Description
Friends for life (FFL). The FFL is a prevention program created by professor Paula Barrett, Brisbane, Australia. It is based on cognitive behavioral treatment strategies, for example the link between thoughts and feelings, negative and positive thoughts, breathing and relaxing exercises, support from others, breaking challenging situation in smaller steps, and problem-solving techniques. The children's workbook comprises practice-sheets for use during class, and homework assignments. The group leader manual comprises detailed instructions to all exercises.
Primary Outcome Measure Information:
Title
Change in SCAS (Spence Children's Anxiety Scale)
Description
Additional assessments using a short version of the SCAS (12 items out of 44) are made at two occasions during intervention (october and november 2013)
Time Frame
Participants are assessed pre intervention, post intervention and up to 12-months
Secondary Outcome Measure Information:
Title
The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)
Time Frame
Assessed up to 12-months
Title
Change in Children's Depression Inventory (CDI)
Time Frame
Assessed pre intervention, post intervention and up to 12 months
Title
Change in Strengths and Difficulties Questionnaire (SDQ)
Description
SDQ is rated by participants' parents and teachers
Time Frame
Assessed pre intervention, post intervention and up to 12 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Written parental consent Exclusion Criteria: No other exclusion criteria since of universal prevention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ata Ghaderi, Dr.
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychology, Uppsala University
City
Uppsala
ZIP/Postal Code
75142
Country
Sweden

12. IPD Sharing Statement

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School-based Universal Prevention for Anxiety and Depression in Sweden: A Cluster-randomized Trial

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