Back to resultsA Randomized Controlled Study of Digitalized Cognitive-behavioral Intervention for Childhood Anxiety
Primary Purpose
Anxiety
Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Digitalized cognitive-behavioral intervention for anxiety
Psychoeducation about anxiety
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
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
Sites / Locations
- Child Psychiatric Research Center, University of Turku
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Digitalized cognitive-behavioral intervention
Psychoeducation about anxiety
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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
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)
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)
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)
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
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)
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)
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
Full Information
NCT ID
NCT03310489
First Posted
September 30, 2017
Last Updated
September 9, 2020
Sponsor
University of Turku
1. Study Identification
Unique Protocol Identification Number
NCT03310489
Brief Title
A Randomized Controlled Study of Digitalized Cognitive-behavioral Intervention for Childhood Anxiety
Official Title
Digitalized Cognitive-behavioral Intervention for Anxiety Among School Children. A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 24, 2017 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turku
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Digitalized cognitive-behavioral intervention
Arm Type
Experimental
Arm Title
Psychoeducation about anxiety
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Digitalized cognitive-behavioral intervention for anxiety
Intervention Description
An internet-based CBT, including telephone coaching
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation about anxiety
Intervention Description
Psychoeducative material about anxiety in internet
Primary Outcome Measure Information:
Title
Change from Baseline to 6 months follow up; the Screen for Child Anxiety Related Disorders - child and parent reports
Description
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 Outcome Measure Information:
Title
Change from Baseline to 6 months follow up; the Child Anxiety Impact Scale - child and parent reports
Description
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
Title
Change from Baseline to 6 months follow up (in the Intervention group); the Development and Well-Being Assessment - child and parent reports
Description
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
Title
Change from Baseline to 6 months follow up; the Revised Children Quality of Life - Questionnaire - child and parent reports
Description
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
Title
Change from Baseline to 6 months follow up; the Child Depression inventory - child report
Description
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
Title
Change from Baseline to 6 months follow up; the Strengths and Difficulties Questionnaire, extended version - parent report
Description
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
Title
Change from Baseline to 6 months follow up of the relations with peers and school (not a standardized scale)
Description
Experience of being bullied (traditional and cyberbullying), and feelings about school and teachers
Time Frame
Change from baseline to 6 months follow up
Title
Change from Baseline to 6 months follow up; the Brief resilience scale - parent report (parental resilience)
Description
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
Title
Change from Baseline to 6 months follow up; the Depression Anxiety and Stress Scale Short Form - parent report (parental depression, anxiety and stress)
Description
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
Title
Change from Baseline to 6 months follow up; the Customised Client Receipt Inventory Questionnaire - parent report
Description
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Child Psychiatric Research Center, University of Turku
City
Turku
ZIP/Postal Code
20500
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
34162641
Citation
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.
Results Reference
derived
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A Randomized Controlled Study of Digitalized Cognitive-behavioral Intervention for Childhood Anxiety
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