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

February 16, 2024 updated by: Andre Sourander, University of Turku

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
465

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, 20500
        • Child Psychiatric Research Center, University of Turku

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Digitalized cognitive-behavioral intervention
Behavioral: Digitalized cognitive-behavioral intervention for anxiety
An internet-based CBT, including telephone coaching
Active Comparator: Psychoeducation about anxiety
Behavioral: Psychoeducation about anxiety
Psychoeducative material about anxiety in internet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Change from baseline to 6 months follow up; symptoms during the last three months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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)
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
A diagnostic interview to assess anxiety disorders among 2-17-year-old children
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
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)
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
Comprises of 28 items assessing the child's depressive symptoms; scoring 0-54 (higher score meaning more symptoms)
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
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)
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
Experience of being bullied (traditional and cyberbullying), and feelings about school and teachers
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
Comprises of six items assessing resilience; scoring 6-36 (higher score meaning higher resilience)
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
Comprises of 21 items assessing parental depression, anxiety and stress; scoring 0-63 (higher score meaning more symptoms)
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
Assesses the child's use of school support services, and social and health care services
Change from baseline to 6 months follow up; service use during the last six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Turku

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 24, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ANXIETY-2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anxiety

Clinical Trials on Digitalized cognitive-behavioral intervention for anxiety

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings