Anxiety DisordersNCT02134730
School-based Universal Prevention for Anxiety and Depression in Sweden: A Cluster-randomized Trial
A study testing FRIENDS for life in people with Anxiety Disorders, run by Uppsala University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- FRIENDS for life
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 695 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Written parental consent
Who cannot join
- No other exclusion criteria since of universal prevention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Anxiety Disorders
- Being tested
- FRIENDS for life
- Keywords
- FRIENDS for life, universal prevention, school children, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRIENDS for lifeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: FRIENDS for life |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Assessed up to 12-months
Change in Children's Depression Inventory (CDI)
Measured: Assessed pre intervention, post intervention and up to 12 months
Change in Strengths and Difficulties Questionnaire (SDQ)
SDQ is rated by participants' parents and teachers
Measured: Assessed pre intervention, post intervention and up to 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startSep 2013
- Primary completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 695 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ata Ghaderi, Dr., Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134730
- Sponsor's protocol ID
- AGJA-01
- Status last verified
- Jan 2015
- First submitted
- 15 Apr 2014
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School-based Universal Prevention for Anxiety and Depression in Sweden: A Cluster-randomized Trial Using the FRIENDS for Life Manual
- ClinicalTrials.gov ID
- NCT02134730
- Acronym / sponsor ID
- AGJA-01
- Conditions
- Anxiety Disorders
- Keywords
- FRIENDS for life, universal prevention, school children, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 695 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jan 2015 (actual)
- First posted
- 9 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: FRIENDS for lifeThe intervention is delivered for 10 consecutive weeks, 60 minutes per session. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Written parental consent
Key exclusion criteria (1 listed)
- No other exclusion criteria since of universal prevention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FRIENDS for lifeFriends 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. | Behavioural | FRIENDS for life |
Primary outcome
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)
3 secondary outcomes
The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)
Time frame: Assessed up to 12-months
Change in Children's Depression Inventory (CDI)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ata Ghaderi, Dr. principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FRIENDS for life in people with Anxiety Disorders, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SCAS (Spence Children's Anxiety Scale) (time frame: Participants are assessed pre intervention, post intervention and up to 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2015.