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CompletedNCT04263558Updated Nov 29, 2023

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

An interventional study of Emotion child in Anxiety Depression, sponsored by Regionsenter for barn og unges psykiske helse. Completed at 3 sites in Norway. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2023-11-29.

Sponsored by Regionsenter for barn og unges psykiske helse · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,364
Allocation
Randomized
Ages
8 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Anxiety Depression

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03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 1,364 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Regionsenter for barn og unges psykiske helse is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
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

Exclusion Criteria:

  • Retardation or language problems
  • Developmental conditions
  • Individual considerations approved by the local PI
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
1,364 participants (actual)

Study arms

  • Active comparator
    LHF

    Long intervention (16 sessions) High parental involvement (5 sessions) Feedback

    Behavioral: Emotion child

  • Active comparator
    LHN

    Long intervention (16 sessions) High parental involvement (5 sessions)

    Behavioral: Emotion child

  • Active comparator
    LLF

    Long intervention (16 sessions) Low parental involvement (Brochure) Feedback

    Behavioral: Emotion child

  • Active comparator
    LLN

    Long intervention (16 sessions) Low parental involvement (Brochure)

    Behavioral: Emotion child

  • Active comparator
    SHF

    Short intervention (8 sessions, group) and 8 sessions web-based High parental involvement (5 sessions) Feedback

    Behavioral: Emotion child

  • Active comparator
    SHN

    Short intervention (8 sessions, group) and 8 sessions web-based High parental involvement (5 sessions)

    Behavioral: Emotion child

  • Active comparator
    SLF

    Short intervention (8 sessions, group) and 8 sessions web-based Low parental involvement (Brochure) Feedback

    Behavioral: Emotion child

  • Active comparator
    SLN

    Short intervention (8 sessions, group) and 8 sessions web-based Low parental involvement (Brochure)

    Behavioral: Emotion child

Interventions

  • BehavioralEmotion 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).

    Also known as: Measurement Feedback System (MFS), Emotion parent

06

What researchers measure

Primary outcomes

  1. Multidimensional Anxiety Scale

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

    Time frame: Time 1 baseline

  2. Multidimensional Anxiety Scale

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

    Time frame: Time 2 after approximal 10 weeks

  3. Multidimensional Anxiety Scale

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

    Time frame: Time 3 after approximal 1 year

  4. Mood and Feeling Questionnaire

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

    Time frame: Time 1 baseline

  5. Mood and Feeling Questionnaire

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

    Time frame: Time 2 after approximal 10 weeks

  6. Mood and Feeling Questionnaire

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

    Time frame: Time 3 after approximal one year

07

Study locations

3 sites
  • Regionsenter for barn og unges psykiske helse
    Oslo, 0484, Norway
  • Regional kunnskapssenter for barn og unge - Nord
    Tromsø, 9037, Norway
  • Regional kunnskapssenter for barn og unge - Midt
    Trondheim, 7491, Norway
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04263558
Lead sponsor
Regionsenter for barn og unges psykiske helse
Collaborators
University of Tromso, Technical University of Trondheim
Responsible party
Simon-Peter Neumer (Dr. Phil., Regionsenter for barn og unges psykiske helse) — Principal investigator
First posted
Feb 11, 2020
Start date
Feb 13, 2020
Primary completion
May 25, 2023
Completion
May 25, 2023
Last update
Nov 29, 2023

Study contacts

Simon-Peter Neumer, Phd
principal investigator · Center for Child and Adolescent Mental Health

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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