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Echo: Optimizing a Group-based School Intervention for Children With Emotional Problems

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04263558
Recruitment Status : Recruiting
First Posted : February 11, 2020
Last Update Posted : February 11, 2020
Sponsor:
Collaborators:
University of Tromso
Technical University of Trondheim
Information provided by (Responsible Party):
Simon-Peter Neumer, Regionsenter for barn og unges psykiske helse

Brief Summary:
The present study (Echo) will promote much needed research and innovation that optimize service provision in first line health services for the alarmingly high number of school children who suffer from clinical and subthreshold levels of anxiety and depression. The effect of different versions of an evidence-based intervention for this group of children will be tested using a cluster randomized design involving 40 schools across Norway. The aim is to create a framework that allows more evidence-based psychosocial interventions to be provided at a lower cost to society. Echo will provide knowledge about three main evidence gaps for children: (1) The effect of school-based preventive interventions on anxiety and depression; (2) The effect of feedback informed systems, and; (3) the effect and cost-effectiveness of digital health interventions using online sessions and virtual reality technology.

Condition or disease Intervention/treatment Phase
Anxiety Depression Behavioral: Emotion child Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 960 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: The study will have a stratified, randomized cluster design. The schools are clusters randomized to different experimental conditions. The factors are (1) feedback from a MFS-system, yes/no, (2) Evidence Based Intervention, long/short (EBI), and (3) parental involvement, high/low. The three factors are related components that, together, should form the strongest intervention outcomes. Each of the 40 recruited schools will therefore be randomly assigned to one of eight experimental conditions
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Echo: Optimizing a Group-based School Intervention for Children With Emotional Problems
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : May 30, 2023
Estimated Study Completion Date : December 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: LHF
Long intervention (16 sessions) High parental involvement (5 sessions) Feedback
Behavioral: Emotion child
The MFS will include an idiographic measure of personal aims, symptom burden, displayed on a visual data dashboard to guide further intervention. The EMOTION intervention for children 9 to 12 years with symptoms of anxiety and/or depression will be used in a standard/long version (16 sessions) and a short (8 sessions) but optimized version, using a partial web-based solution with virtual reality (VR)-technology for behavioral experiments and exposure (in short and long version). Parental involvement: Parental participation in a 5-session parent group (high involvement) versus sharing information with parents via a brochure (low Parental involvement).
Other Names:
  • Measurement Feedback System (MFS)
  • Emotion parent

Active Comparator: LHN
Long intervention (16 sessions) High parental involvement (5 sessions)
Behavioral: Emotion child
The MFS will include an idiographic measure of personal aims, symptom burden, displayed on a visual data dashboard to guide further intervention. The EMOTION intervention for children 9 to 12 years with symptoms of anxiety and/or depression will be used in a standard/long version (16 sessions) and a short (8 sessions) but optimized version, using a partial web-based solution with virtual reality (VR)-technology for behavioral experiments and exposure (in short and long version). Parental involvement: Parental participation in a 5-session parent group (high involvement) versus sharing information with parents via a brochure (low Parental involvement).
Other Names:
  • Measurement Feedback System (MFS)
  • Emotion parent

Active Comparator: LLF
Long intervention (16 sessions) Low parental involvement (Brochure) Feedback
Behavioral: Emotion child
The MFS will include an idiographic measure of personal aims, symptom burden, displayed on a visual data dashboard to guide further intervention. The EMOTION intervention for children 9 to 12 years with symptoms of anxiety and/or depression will be used in a standard/long version (16 sessions) and a short (8 sessions) but optimized version, using a partial web-based solution with virtual reality (VR)-technology for behavioral experiments and exposure (in short and long version). Parental involvement: Parental participation in a 5-session parent group (high involvement) versus sharing information with parents via a brochure (low Parental involvement).
Other Names:
  • Measurement Feedback System (MFS)
  • Emotion parent

Active Comparator: LLN
Long intervention (16 sessions) Low parental involvement (Brochure)
Behavioral: Emotion child
The MFS will include an idiographic measure of personal aims, symptom burden, displayed on a visual data dashboard to guide further intervention. The EMOTION intervention for children 9 to 12 years with symptoms of anxiety and/or depression will be used in a standard/long version (16 sessions) and a short (8 sessions) but optimized version, using a partial web-based solution with virtual reality (VR)-technology for behavioral experiments and exposure (in short and long version). Parental involvement: Parental participation in a 5-session parent group (high involvement) versus sharing information with parents via a brochure (low Parental involvement).
Other Names:
  • Measurement Feedback System (MFS)
  • Emotion parent

Active Comparator: SHF
Short intervention (8 sessions, group) and 8 sessions web-based High parental involvement (5 sessions) Feedback
Behavioral: Emotion child
The MFS will include an idiographic measure of personal aims, symptom burden, displayed on a visual data dashboard to guide further intervention. The EMOTION intervention for children 9 to 12 years with symptoms of anxiety and/or depression will be used in a standard/long version (16 sessions) and a short (8 sessions) but optimized version, using a partial web-based solution with virtual reality (VR)-technology for behavioral experiments and exposure (in short and long version). Parental involvement: Parental participation in a 5-session parent group (high involvement) versus sharing information with parents via a brochure (low Parental involvement).
Other Names:
  • Measurement Feedback System (MFS)
  • Emotion parent

Active Comparator: SHN
Short intervention (8 sessions, group) and 8 sessions web-based High parental involvement (5 sessions)
Behavioral: Emotion child
The MFS will include an idiographic measure of personal aims, symptom burden, displayed on a visual data dashboard to guide further intervention. The EMOTION intervention for children 9 to 12 years with symptoms of anxiety and/or depression will be used in a standard/long version (16 sessions) and a short (8 sessions) but optimized version, using a partial web-based solution with virtual reality (VR)-technology for behavioral experiments and exposure (in short and long version). Parental involvement: Parental participation in a 5-session parent group (high involvement) versus sharing information with parents via a brochure (low Parental involvement).
Other Names:
  • Measurement Feedback System (MFS)
  • Emotion parent

Active Comparator: SLF
Short intervention (8 sessions, group) and 8 sessions web-based Low parental involvement (Brochure) Feedback
Behavioral: Emotion child
The MFS will include an idiographic measure of personal aims, symptom burden, displayed on a visual data dashboard to guide further intervention. The EMOTION intervention for children 9 to 12 years with symptoms of anxiety and/or depression will be used in a standard/long version (16 sessions) and a short (8 sessions) but optimized version, using a partial web-based solution with virtual reality (VR)-technology for behavioral experiments and exposure (in short and long version). Parental involvement: Parental participation in a 5-session parent group (high involvement) versus sharing information with parents via a brochure (low Parental involvement).
Other Names:
  • Measurement Feedback System (MFS)
  • Emotion parent

Active Comparator: SLN
Short intervention (8 sessions, group) and 8 sessions web-based Low parental involvement (Brochure)
Behavioral: Emotion child
The MFS will include an idiographic measure of personal aims, symptom burden, displayed on a visual data dashboard to guide further intervention. The EMOTION intervention for children 9 to 12 years with symptoms of anxiety and/or depression will be used in a standard/long version (16 sessions) and a short (8 sessions) but optimized version, using a partial web-based solution with virtual reality (VR)-technology for behavioral experiments and exposure (in short and long version). Parental involvement: Parental participation in a 5-session parent group (high involvement) versus sharing information with parents via a brochure (low Parental involvement).
Other Names:
  • Measurement Feedback System (MFS)
  • Emotion parent




Primary Outcome Measures :
  1. Multidimensional Anxiety Scale [ Time Frame: Time 1 baseline ]
    Anxiety symptoms

  2. Multidimensional Anxiety Scale [ Time Frame: Time 2 after approximal 10 weeks ]
    Anxiety symptoms

  3. Multidimensional anxiety scale [ Time Frame: Time 3 after approximal 1 year ]
    Anxiety symptoms

  4. Mood and Feeling Questionnaire [ Time Frame: Time 1 baseline ]
    Depression symptoms

  5. Mood and Feeling Questionnaire [ Time Frame: Time 3 after approximal 10 weeks ]
    Depression symptoms

  6. Mood and Feeling Questionnaire [ Time Frame: Time 3 after approximal one year ]
    Depression symptoms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   9 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• Children scoring one standard deviation or more above population mean using established measures for anxiety and/or depression

Exclusion Criteria:

  • Retardation or language problems
  • Developmental conditions
  • Individual considerations approved by the local PI

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): NCT04263558


Contacts
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Contact: Simon-Peter Neumer, Phd +4795820508 simon-peter.neumer@r-bup.no
Contact: Solveig Holen, Phd +4793017776 solveig.holen@r-bup.no

Locations
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Norway
Regionsenter for barn og unges psykiske helse Recruiting
Oslo, Norway, 0484
Contact: Kristin Martinsen, Phd    +47 99586031    kristin.martinsen@r-bup.no   
Contact: Solveig Holen, Phd    004793017776    solveig.holen@r-bup.no   
Principal Investigator: Kristin Dagmar Martinsen, Phd         
Sub-Investigator: Simon-Peter Neumer, Phd         
Regional kunnskapssenter for barn og unge - Nord Recruiting
Tromsø, Norway, 9037
Contact: Joshua Patras, Dr. Philos    +4747455939    joshua.patras@uit.no   
Contact: Frode Adolfsen    004791126323    frode.adolfsen@uit.no   
Sub-Investigator: Joshua Patras, Dr. Philos         
Principal Investigator: Frode Adolfsen         
Regional kunnskapssenter for barn og unge - Midt Recruiting
Trondheim, Norway, 7491
Contact: Anne Mari Sund, Dr. med    +4792607464    anne.m.sund@ntnu.no   
Sub-Investigator: Anne Mari Sund, Dr. med.         
Principal Investigator: Jo Magne Ingul, Phd         
Sponsors and Collaborators
Regionsenter for barn og unges psykiske helse
University of Tromso
Technical University of Trondheim
Investigators
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Principal Investigator: Simon-Peter Neumer, Phd Center for Child and Adolescent Mental Health

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Responsible Party: Simon-Peter Neumer, Dr. Phil., Regionsenter for barn og unges psykiske helse
ClinicalTrials.gov Identifier: NCT04263558    
Other Study ID Numbers: 31/18
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Depression
Behavioral Symptoms