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Trial record 25 of 1546 for:    child psychiatry

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

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ClinicalTrials.gov Identifier: NCT03310489
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Andre Sourander, University of Turku

Tracking Information
First Submitted Date  ICMJE September 30, 2017
First Posted Date  ICMJE October 16, 2017
Last Update Posted Date November 5, 2019
Actual Study Start Date  ICMJE October 24, 2017
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2018)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: October 9, 2017)
Change from Baseline to 6 months follow up; the Screen for Child Anxiety Related Disorders - child report [ Time Frame: Change from baseline to 6 months follow up; symptoms during the last three months ]
Comprises of 41 items assessing general anxiety, separation anxiety, panic disorder, social anxiety, and school phobia
Change History Complete list of historical versions of study NCT03310489 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2017)
  • Change from Baseline to 6 months follow up; the Screen for Child Anxiety Related Disorders - parent report [ Time Frame: Change from baseline to 6 months follow up; symptoms during the last three months ]
    Comprises of 41 items assessing general anxiety, separation anxiety, panic disorder, social anxiety, and school phobia
  • 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
  • Change from Baseline to 6 months follow up; 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 5-17-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
  • 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
  • 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
  • Change from Baseline to 6 months follow up of the relations with peers and school [ 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 (for parental resilience) [ Time Frame: Change from baseline to 6 months follow up; experience of the current resilience ]
    Comprises of six items assessing resilience
  • Change from Baseline to 6 months follow up; the Depression Anxiety and Stress Scale Short Form - parent report [ 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Controlled Study of Digitalized Cognitive-behavioral Intervention for Childhood Anxiety
Official Title  ICMJE Digitalized Cognitive-behavioral Intervention for Anxiety Among School Children. A Randomized Controlled Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anxiety
Intervention  ICMJE
  • Behavioral: Digitalized cognitive-behavioral intervention for anxiety
    An internet-based CBT, including telephone coaching
  • Behavioral: Psychoeducation about anxiety
    Psychoeducative material about anxiety in internet
Study Arms  ICMJE
  • Experimental: Digitalized cognitive-behavioral intervention
    Intervention: Behavioral: Digitalized cognitive-behavioral intervention for anxiety
  • Active Comparator: Psychoeducation about anxiety
    Intervention: Behavioral: Psychoeducation about anxiety
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 9, 2017)
360
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Terhi Luntamo, MD, PhD +358-2-3337395 tetulu@utu.fi
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03310489
Other Study ID Numbers  ICMJE ANXIETY-2017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andre Sourander, University of Turku
Study Sponsor  ICMJE University of Turku
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Turku
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP