AnxietyNCT03310489
A Randomized Controlled Study of Digitalized Cognitive-behavioral Intervention for Childhood Anxiety
A study testing Digitalized cognitive-behavioral intervention for anxiety and Psychoeducation about anxiety in people with Anxiety, run by University of Turku at 1 site in Finland.
Trial summary
The aim of the study is to evaluate the effectiveness of a digitalized cognitive-behavioral treatment for anxiety among school aged children. The participants are screened from the general population, as a part of the routine school health care check-ups. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anxiety
- What is being tested?
- Digitalized cognitive-behavioral intervention for anxiety and Psychoeducation about anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 465 participants
- Where
- 1 siteFinland
- Study dates
- 24 Oct 2017to 15 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Scoring ≥22 on SCARED
Who cannot join
- no access to internet
- insufficient language (Finnish until summer 2019, Finnish and Swedish from autumn 2019 onwards, when also Swedish version of the intervention was available) skills
- visual or hearing impairment that hinders the use of the program
- the child's mental retardation, autism spectrum disorder, suicidal intentions or severe mental disorder
- the child's psychotherapy (ongoing or starting within 6 months)
- the child's medication (for anxiety) started / changed within 2 months
- current involvement with child protection services (i.e., removal of child custody, investigation of child abuse or neglect)
- parent's severe psychiatric / somatic disease or other reason that hinders the parent to actively participate in the program
Trial locations and contacts
1 site in 1 country.
Finland1 site
Child Psychiatric Research Center, University of Turku
Turku, 20500
About this study
Official title: Digitalized Cognitive-behavioral Intervention for Anxiety Among School Children. A Randomized Controlled Study
The aim of the study is to evaluate the effectiveness of a digitalized cognitive-behavioral treatment for anxiety among school aged children. The participants are screened from the general population, as a part of the routine school health care check-ups. Half of the children with anxiety will receive the digitalized treatment program, while the other half will receive education about anxiety in internet.
- Conditions
- Anxiety
- Being tested
- Digitalized cognitive-behavioral intervention for anxiety, Psychoeducation about 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.
Digitalized cognitive-behavioral intervention for anxietyBehavioural
An internet-based CBT, including telephone coaching
Psychoeducation about anxietyBehavioural
Psychoeducative material about anxiety in internet
| Study group | Role | What they receive |
|---|---|---|
| Digitalized cognitive-behavioral intervention | Experimental | Not described Receives: Behavioral: Digitalized cognitive-behavioral intervention for anxiety |
| Psychoeducation about anxiety | Active comparator | Not described Receives: Behavioral: Psychoeducation about anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to 6 months follow up; the Screen for Child Anxiety Related Disorders - child and parent reports
Comprises of 41 items assessing symptoms of general anxiety, separation anxiety, panic disorder, social anxiety, and school phobia; scoring 0-82 (higher score meaning more symptoms)
Measured: Change from baseline to 6 months follow up; symptoms during the last three months
Secondary outcomes (9)
Change from Baseline to 6 months follow up; the Child Anxiety Impact Scale - child and parent reports
Comprises of 27 items assessing the impact of anxiety on the daily life of the children at home, school and with friends; scoring 0-81 (higher score meaning higher impact of anxiety)
Measured: Change from baseline to 6 months follow up; impact of anxiety during the last month
Change from Baseline to 6 months follow up (in the Intervention group); the Development and Well-Being Assessment - child and parent reports
A diagnostic interview to assess anxiety disorders among 2-17-year-old children
Measured: Change from baseline to 6 months follow up; varying time windows for different diagnoses
Change from Baseline to 6 months follow up; the Revised Children Quality of Life - Questionnaire - child and parent reports
Comprises of 24 items assessing the health-related quality of life divided into six subscales: physical, psychological, self-esteem, family, social life, and school; scoring 24-96 (higher score meaning higher QoL)
Measured: Change from baseline to 6 months follow up; QoL during the last week
Change from Baseline to 6 months follow up; the Child Depression inventory - child report
Comprises of 28 items assessing the child's depressive symptoms; scoring 0-54 (higher score meaning more symptoms)
Measured: Change from baseline to 6 months follow up; symptoms during the last two weeks
Change from Baseline to 6 months follow up; the Strengths and Difficulties Questionnaire, extended version - parent report
Comprises of 25 items assessing the child's psychiatric symptoms and positive attributes, and an impact supplement; scoring 0-40 (prosocial scale is not included in the total score) (higher score meaning more problems)
Measured: Change from baseline to 6 months follow up; symptoms during the last six months
Change from Baseline to 6 months follow up of the relations with peers and school (not a standardized scale)
Experience of being bullied (traditional and cyberbullying), and feelings about school and teachers
Measured: Change from baseline to 6 months follow up
Change from Baseline to 6 months follow up; the Brief resilience scale - parent report (parental resilience)
Comprises of six items assessing resilience; scoring 6-36 (higher score meaning higher resilience)
Measured: Change from baseline to 6 months follow up; experience of the current resilience
Change from Baseline to 6 months follow up; the Depression Anxiety and Stress Scale Short Form - parent report (parental depression, anxiety and stress)
Comprises of 21 items assessing parental depression, anxiety and stress; scoring 0-63 (higher score meaning more symptoms)
Measured: Change from baseline to 6 months follow up; symptoms during the last week
Change from Baseline to 6 months follow up; the Customised Client Receipt Inventory Questionnaire - parent report
Assesses the child's use of school support services, and social and health care services
Measured: Change from baseline to 6 months follow up; service use during the last six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start24 Oct 2017
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Sourander, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310489
- Sponsor's protocol ID
- ANXIETY-2017
- Status last verified
- Feb 2024
- First submitted
- 30 Sep 2017
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sourander A, Korpilahti-Leino T, Kaajalaakso K, Ristkari T, Hinkka-Yli-Salomaki S, Stahlberg T, Luntamo T. Internet-Based Cognitive-Behavioral Therapy Intervention Master Your Worries With Telephone Coaching for Anxious Finnish Children Aged 10-13 Years: A Population-Based Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2025 Nov;64(11):1281-1294. doi: 10.1016/j.jaac.2024.11.024. Epub 2025 Feb 4.
PubMed 39914585Luntamo T, Korpilahti-Leino T, Ristkari T, Hinkka-Yli-Salomaki S, Kurki M, Sinokki A, Lamminen K, Saanakorpi K, Saarinen S, Maunuksela M, Sourander S, Toivonen K, Zadkova A, Suilamo M, Casagrande L, Palmroth J, Sourander A. Internet-assisted cognitive behavioural therapy with telephone coaching for anxious Finnish children aged 10-13 years: study protocol for a randomised controlled trial. BMJ Open. 2021 Jun 23;11(6):e045474. doi: 10.1136/bmjopen-2020-045474.
PubMed 34162641
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digitalized Cognitive-behavioral Intervention for Anxiety Among School Children. A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03310489
- Acronym / sponsor ID
- ANXIETY-2017
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 16 Oct 2017 (actual)
- 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.
The aim of the study is to evaluate the effectiveness of a digitalized cognitive-behavioral treatment for anxiety among school aged children. The participants are screened from the general population, as a part of the routine school health care check-ups. Half of the children with anxiety will receive the digitalized treatment program, while the other half will receive education about anxiety in internet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digitalized cognitive-behavioral intervention | Experimental | Behavioral: Digitalized cognitive-behavioral intervention for anxiety |
| Psychoeducation about anxiety | Active comparator | Behavioral: Psychoeducation about anxiety |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Scoring ≥22 on SCARED
Key exclusion criteria (8 listed)
- no access to internet
- insufficient language (Finnish until summer 2019, Finnish and Swedish from autumn 2019 onwards, when also Swedish version of the intervention was available) skills
- visual or hearing impairment that hinders the use of the program
- the child's mental retardation, autism spectrum disorder, suicidal intentions or severe mental disorder
- the child's psychotherapy (ongoing or starting within 6 months)
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 |
|---|---|---|
| Digitalized cognitive-behavioral intervention for anxietyAn internet-based CBT, including telephone coaching | Behavioural | Digitalized cognitive-behavioral intervention |
| Psychoeducation about anxietyPsychoeducative material about anxiety in internet | Behavioural | Psychoeducation about anxiety |
Primary outcome
Change from Baseline to 6 months follow up; the Screen for Child Anxiety Related Disorders - child and parent reports
Time frame: Change from baseline to 6 months follow up; symptoms during the last three months
Comprises of 41 items assessing symptoms of general anxiety, separation anxiety, panic disorder, social anxiety, and school phobia; scoring 0-82 (higher score meaning more symptoms)
9 secondary outcomes
Change from Baseline to 6 months follow up; the Child Anxiety Impact Scale - child and parent reports
Time frame: Change from baseline to 6 months follow up; impact of anxiety during the last month
Change from Baseline to 6 months follow up (in the Intervention group); the Development and Well-Being Assessment - child and parent reports
Time frame: Change from baseline to 6 months follow up; varying time windows for different diagnoses
Change from Baseline to 6 months follow up; the Revised Children Quality of Life - Questionnaire - child and parent reports
Time frame: Change from baseline to 6 months follow up; QoL during the last week
Change from Baseline to 6 months follow up; the Child Depression inventory - child report
Time frame: Change from baseline to 6 months follow up; symptoms during the last two weeks
Change from Baseline to 6 months follow up; the Strengths and Difficulties Questionnaire, extended version - parent report
Time frame: Change from baseline to 6 months follow up; symptoms during the last six months
Change from Baseline to 6 months follow up of the relations with peers and school (not a standardized scale)
Time frame: Change from baseline to 6 months follow up
Change from Baseline to 6 months follow up; the Brief resilience scale - parent report (parental resilience)
Time frame: Change from baseline to 6 months follow up; experience of the current resilience
Change from Baseline to 6 months follow up; the Depression Anxiety and Stress Scale Short Form - parent report (parental depression, anxiety and stress)
Time frame: Change from baseline to 6 months follow up; symptoms during the last week
Change from Baseline to 6 months follow up; the Customised Client Receipt Inventory Questionnaire - parent report
Time frame: Change from baseline to 6 months follow up; service use during the last six months
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 20 Feb 2024.
- Derived from this study: PubMed 39914585Sourander A, Korpilahti-Leino T, Kaajalaakso K, Ristkari T, Hinkka-Yli-Salomaki S, Stahlberg T, Luntamo T. Internet-Based Cognitive-Behavioral Therapy Intervention Master Your Worries With Telephone Coaching for Anxious Finnish Children Aged 10-13 Years: A Population-Based Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2025 Nov;64(11):1281-1294. doi: 10.1016/j.jaac.2024.11.024. Epub 2025 Feb 4.
- Derived from this study: PubMed 34162641Luntamo T, Korpilahti-Leino T, Ristkari T, Hinkka-Yli-Salomaki S, Kurki M, Sinokki A, Lamminen K, Saanakorpi K, Saarinen S, Maunuksela M, Sourander S, Toivonen K, Zadkova A, Suilamo M, Casagrande L, Palmroth J, Sourander A. Internet-assisted cognitive behavioural therapy with telephone coaching for anxious Finnish children aged 10-13 years: study protocol for a randomised controlled trial. BMJ Open. 2021 Jun 23;11(6):e045474. doi: 10.1136/bmjopen-2020-045474.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digitalized cognitive-behavioral intervention for anxiety and Psychoeducation about anxiety in people with Anxiety, run by University of Turku at 1 site in Finland.
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 8 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 20 Feb 2024. 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 Finland. 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 from Baseline to 6 months follow up; the Screen for Child Anxiety Related Disorders - child and parent reports (time frame: Change from baseline to 6 months follow up; symptoms during the last three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03310489, which also lists 2 linked publications.
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 20 Feb 2024.