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Trial record 25 of 1522 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 : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Andre Sourander, University of Turku

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.

Condition or disease Intervention/treatment Phase
Anxiety Behavioral: Digitalized cognitive-behavioral intervention for anxiety Behavioral: Psychoeducation about anxiety Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Digitalized Cognitive-behavioral Intervention for Anxiety Among School Children. A Randomized Controlled Study
Actual Study Start Date : October 24, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Scoring ≥22 on SCARED

Exclusion Criteria:

  • no access to internet
  • insufficient language (Finnish) 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310489


Contacts
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Contact: Terhi Luntamo, MD, PhD +358-2-3337395 tetulu@utu.fi

Locations
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Finland
Child Psychiatric Research Center, University of Turku Recruiting
Turku, Finland, 20500
Contact: Terhi Luntamo, MD, PhD    +358-2-3337395    tetulu@utu.fi   
Sponsors and Collaborators
University of Turku

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Responsible Party: Andre Sourander, Professor (child psychiatry), University of Turku
ClinicalTrials.gov Identifier: NCT03310489     History of Changes
Other Study ID Numbers: ANXIETY-2017
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders