NCT02134730

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
695

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2014

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 9, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Last Updated

January 30, 2015

Status Verified

January 1, 2015

Enrollment Period

1.3 years

First QC Date

April 15, 2014

Last Update Submit

January 29, 2015

Conditions

Keywords

FRIENDS for lifeuniversal preventionschool childrenanxiety

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)

    Assessed up to 12-months

  • Change in Children's Depression Inventory (CDI)

    Assessed pre intervention, post intervention and up to 12 months

  • Change in Strengths and Difficulties Questionnaire (SDQ)

    Assessed pre intervention, post intervention and up to 12 months follow-up

Study Arms (2)

Wait list

NO INTERVENTION

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.

FRIENDS for life

EXPERIMENTAL

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

Behavioral: FRIENDS for life

Interventions

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.

FRIENDS for life

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Written parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, Uppsala University

Uppsala, 75142, Sweden

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Ata Ghaderi, Dr.

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2014

First Posted

May 9, 2014

Study Start

September 1, 2013

Primary Completion

January 1, 2015

Last Updated

January 30, 2015

Record last verified: 2015-01

Locations