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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02134730
• Other study ID #: AGJA-01
• Status: Completed
• Phase: N/A
• First received: April 15, 2014
• Last updated: January 29, 2015
• Start date: September 2013

Study information

• Verified date: January 2015
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 695
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• Written parental consent

Exclusion Criteria:

• No other exclusion criteria since of universal prevention

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

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.

Locations

Country	Name	City	State
Sweden	Department of Psychology, Uppsala University	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Participants are assessed pre intervention, post intervention and up to 12-months	No
Secondary	The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)		Assessed up to 12-months	No
Secondary	Change in Children's Depression Inventory (CDI)		Assessed pre intervention, post intervention and up to 12 months	No
Secondary	Change in Strengths and Difficulties Questionnaire (SDQ)	SDQ is rated by participants' parents and teachers	Assessed pre intervention, post intervention and up to 12 months follow-up	No