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

January 29, 2015 updated by: Uppsala University

School-based Universal Prevention for Anxiety and Depression in Sweden: A Cluster-randomized Trial Using the FRIENDS for Life Manual

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. 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?

  2. 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:

  3. Is there any congruence between parents' and children's estimates of the child's anxiety symptoms?
  4. Do FRIEND for life affect parents' and teachers' estimates of children's general mental health?
  5. 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.

Study Type

Interventional

Enrollment (Actual)

695

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

  • Sweden
      • Uppsala, Sweden, 75142
        • Department of Psychology, Uppsala University

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

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written parental consent

Exclusion Criteria:

  • No other exclusion criteria since of universal prevention

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Wait list
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.
Experimental: FRIENDS for life
The intervention is delivered for 10 consecutive weeks, 60 minutes per session.
Behavioral: FRIENDS for life
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in SCAS (Spence Children's Anxiety Scale)
Time Frame: Participants are assessed pre intervention, post intervention and up to 12-months
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)
Participants are assessed pre intervention, post intervention and up to 12-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)
Time Frame: Assessed up to 12-months
Assessed up to 12-months
Change in Children's Depression Inventory (CDI)
Time Frame: Assessed pre intervention, post intervention and up to 12 months
Assessed pre intervention, post intervention and up to 12 months
Change in Strengths and Difficulties Questionnaire (SDQ)
Time Frame: Assessed pre intervention, post intervention and up to 12 months follow-up
SDQ is rated by participants' parents and teachers
Assessed pre intervention, post intervention and up to 12 months follow-up

Collaborators and Investigators

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

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Ata Ghaderi, Dr., Karolinska Institutet

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

September 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

April 15, 2014

First Submitted That Met QC Criteria

May 7, 2014

First Posted (Estimate)

May 9, 2014

Study Record Updates

Last Update Posted (Estimate)

January 30, 2015

Last Update Submitted That Met QC Criteria

January 29, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGJA-01

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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