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

Sponsor
Regionsenter for barn og unges psykiske helse (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04263558
Collaborator
University of Tromso (Other), Technical University of Trondheim (Other)
960
Enrollment
3
Locations
8
Arms
46
Anticipated Duration (Months)
320
Patients Per Site
7
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: Emotion child
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 conditionsThe 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
Actual Study Start Date :
Feb 13, 2020
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
Dec 15, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Multidimensional Anxiety Scale [Time 1 baseline]

      Anxiety symptoms, minimum 0 to maximum 117, high score indicates worse outcome

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

      Anxiety symptoms, minimum 0 to maximum 117, high score indicates worse outcome

    3. Multidimensional Anxiety Scale [Time 3 after approximal 1 year]

      Anxiety symptoms, minimum 0 to maximum 117, high score indicates worse outcome

    4. Mood and Feeling Questionnaire [Time 1 baseline]

      Depression symptoms, minimum 0 to maximum 26, high score indicates worse outcome

    5. Mood and Feeling Questionnaire [Time 2 after approximal 10 weeks]

      Depression symptoms, minimum 0 to maximum 26, high score indicates worse outcome

    6. Mood and Feeling Questionnaire [Time 3 after approximal one year]

      Depression symptoms, minimum 0 to maximum 26, high score indicates worse outcome

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Regionsenter for barn og unges psykiske helse Oslo Norway 0484
    2 Regional kunnskapssenter for barn og unge - Nord Tromsø Norway 9037
    3 Regional kunnskapssenter for barn og unge - Midt Trondheim Norway 7491

    Sponsors and Collaborators

    • Regionsenter for barn og unges psykiske helse
    • University of Tromso
    • Technical University of Trondheim

    Investigators

    • Principal Investigator: Simon-Peter Neumer, Phd, Center for Child and Adolescent Mental Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Feb 11, 2020
    Last Update Posted:
    Jan 25, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Depression

    Study Results

    No Results Posted as of Jan 25, 2021