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

Overview

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.

Full Title of Study: “Digitalized Cognitive-behavioral Intervention for Anxiety Among School Children. A Randomized Controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2020

Interventions

  • Behavioral: Digitalized cognitive-behavioral intervention for anxiety
    • An internet-based CBT, including telephone coaching
  • Behavioral: Psychoeducation about anxiety
    • Psychoeducative material about anxiety in internet

Arms, Groups and Cohorts

  • Experimental: Digitalized cognitive-behavioral intervention
  • Active Comparator: Psychoeducation about anxiety

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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 (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; 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; 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; 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 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; 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; 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; 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Turku
  • Provider of Information About this Clinical Study
    • Principal Investigator: Andre Sourander, Professor (child psychiatry) – University of Turku

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