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Completed

NCT Number: NCT03310489

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

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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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Child Psychiatric Research Center, University of Turku

Turku, 20500, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digitalized cognitive-behavioral intervention for anxiety

Behavioral

An internet-based CBT, including telephone coaching

Psychoeducation about anxiety

Behavioral

Psychoeducative material about anxiety in internet

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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

  3. 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)

  4. 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)

  5. 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)

  6. 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

  7. 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)

  8. 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)

  9. 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

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Registry information

Official study title

Digitalized Cognitive-behavioral Intervention for Anxiety Among School Children. A Randomized Controlled Study

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 16, 2017
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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