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CompletedNCT03310489Updated Feb 20, 2024

A Randomized Controlled Study of Digitalized Cognitive-behavioral Intervention for Childhood Anxiety

An interventional study of Digitalized cognitive-behavioral intervention for anxiety and Psychoeducation about anxiety in Anxiety, sponsored by University of Turku. Completed at 1 site in Finland. Per ClinicalTrials.gov, last updated 2024-02-20.

Primary conditionAnxiety Disorders(the registry's first term)UnverifiedIs this wrong?The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by University of Turku · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
465
Allocation
Randomized
Sex
All
01

Study 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. Half of the children with anxiety will receive the digitalized treatment program, while the other half will receive education about anxiety in internet.

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Conditions studied

  • Anxiety

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03

In context

Anxiety Disorders Unverified

7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's enrollment of 465 is above the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

University of Turku is the lead sponsor of 122 studies on the registry; 16 are open to participants now.

Browse University of Turku studies →

Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Scoring ≥22 on SCARED

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
465 participants (actual)

Study arms

  • Experimental
    Digitalized cognitive-behavioral intervention

    Behavioral: Digitalized cognitive-behavioral intervention for anxiety

  • Active comparator
    Psychoeducation about anxiety

    Behavioral: Psychoeducation about anxiety

Interventions

  • BehavioralDigitalized cognitive-behavioral intervention for anxiety

    An internet-based CBT, including telephone coaching

  • BehavioralPsychoeducation about anxiety

    Psychoeducative material about anxiety in internet

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What researchers measure

Primary outcomes

  1. 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)

    Time frame: Change from baseline to 6 months follow up; symptoms during the last three months

Secondary outcomes

  1. 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)

    Time frame: Change from baseline to 6 months follow up; impact of anxiety during the last month

  2. 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

    Time frame: Change from baseline to 6 months follow up; varying time windows for different diagnoses

  3. 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)

    Time frame: Change from baseline to 6 months follow up; QoL during the last week

  4. 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)

    Time frame: Change from baseline to 6 months follow up; symptoms during the last two weeks

  5. 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)

    Time frame: Change from baseline to 6 months follow up; symptoms during the last six months

  6. 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

    Time frame: Change from baseline to 6 months follow up

  7. 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)

    Time frame: Change from baseline to 6 months follow up; experience of the current resilience

  8. 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)

    Time frame: Change from baseline to 6 months follow up; symptoms during the last week

  9. 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

    Time frame: Change from baseline to 6 months follow up; service use during the last six months

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Study locations

1 site
  • Child Psychiatric Research Center, University of Turku
    Turku, 20500, Finland
08

References and documents

Publications

  • Luntamo 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 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Dec 2020, 37 months.

Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 37 months is above that.

Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 30, 2017
First posted
Oct 16, 2017
StartActual
Oct 24, 2017
Primary completionActual
Dec 15, 2020
CompletionActual
Dec 15, 2020
Last update
Feb 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03310489
Lead sponsor
University of Turku
Responsible party
Andre Sourander (Professor (child psychiatry), University of Turku) — Principal investigator
First posted
Oct 16, 2017
Start date
Oct 24, 2017
Primary completion
Dec 15, 2020
Completion
Dec 15, 2020
Last update
Feb 20, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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