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

NCT ID: NCT03310489

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

465 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-24

Study Completion Date

2020-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Digitalized cognitive-behavioral intervention

Group Type EXPERIMENTAL

Digitalized cognitive-behavioral intervention for anxiety

Intervention Type BEHAVIORAL

An internet-based CBT, including telephone coaching

Psychoeducation about anxiety

Group Type ACTIVE_COMPARATOR

Psychoeducation about anxiety

Intervention Type BEHAVIORAL

Psychoeducative material about anxiety in internet

Interventions

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Digitalized cognitive-behavioral intervention for anxiety

An internet-based CBT, including telephone coaching

Intervention Type BEHAVIORAL

Psychoeducation about anxiety

Psychoeducative material about anxiety in internet

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

\- Scoring ≥22 on SCARED

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turku

OTHER

Sponsor Role lead

Responsible Party

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Andre Sourander

Professor (child psychiatry)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Child Psychiatric Research Center, University of Turku

Turku, , Finland

Site Status

Countries

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Finland

References

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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 Feb 4:S0890-8567(25)00065-6. doi: 10.1016/j.jaac.2024.11.024. Online ahead of print.

Reference Type DERIVED
PMID: 39914585 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34162641 (View on PubMed)

Other Identifiers

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ANXIETY-2017

Identifier Type: -

Identifier Source: org_study_id

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