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Anxiety DepressionNCT04263558

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

A study testing Emotion child in people with Anxiety Depression, run by Regionsenter for barn og unges psykiske helse at 3 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 12 years
Conditions the study is for
Anxiety Depression
What is being tested?
Emotion child
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,364 participants
Where
3 sitesNorway
Study dates
13 Feb 2020to 25 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Norway3 sites

  • Regionsenter for barn og unges psykiske helse

    Oslo, 0484

  • Regional kunnskapssenter for barn og unge - Nord

    Tromsø, 9037

  • Regional kunnskapssenter for barn og unge - Midt

    Trondheim, 7491

Other trials in Norway

About this study

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.

Being tested
Emotion child

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emotion childBehavioural

    Also called Measurement Feedback System (MFS), Emotion parent

    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).

Study groups in NCT04263558
Study groupRoleWhat they receive
LHFActive comparatorLong intervention (16 sessions) High parental involvement (5 sessions) Feedback
Receives: Behavioral: Emotion child
LHNActive comparatorLong intervention (16 sessions) High parental involvement (5 sessions)
Receives: Behavioral: Emotion child
LLFActive comparatorLong intervention (16 sessions) Low parental involvement (Brochure) Feedback
Receives: Behavioral: Emotion child
LLNActive comparatorLong intervention (16 sessions) Low parental involvement (Brochure)
Receives: Behavioral: Emotion child
SHFActive comparatorShort intervention (8 sessions, group) and 8 sessions web-based High parental involvement (5 sessions) Feedback
Receives: Behavioral: Emotion child
SHNActive comparatorShort intervention (8 sessions, group) and 8 sessions web-based High parental involvement (5 sessions)
Receives: Behavioral: Emotion child
SLFActive comparatorShort intervention (8 sessions, group) and 8 sessions web-based Low parental involvement (Brochure) Feedback
Receives: Behavioral: Emotion child
SLNActive comparatorShort intervention (8 sessions, group) and 8 sessions web-based Low parental involvement (Brochure)
Receives: Behavioral: Emotion child

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Multidimensional Anxiety Scale

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

    Measured: Time 1 baseline

  2. Multidimensional Anxiety Scale

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

    Measured: Time 2 after approximal 10 weeks

  3. Multidimensional Anxiety Scale

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

    Measured: Time 3 after approximal 1 year

  4. Mood and Feeling Questionnaire

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

    Measured: Time 1 baseline

  5. Mood and Feeling Questionnaire

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

    Measured: Time 2 after approximal 10 weeks

  6. Mood and Feeling Questionnaire

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

    Measured: Time 3 after approximal one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2020
  2. Study start13 Feb 2020
  3. Primary completion25 May 2023
  4. Study completion25 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
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)
Enrolment
1,364 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04263558
Sponsor's protocol ID
31/18
Status last verified
Nov 2023
First submitted
27 Nov 2019
Last updated
29 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lisoy C, Neumer SP, Waaktaar T, Wentzel-Larsen T, Ingul JM, Adolfsen F, Holen S, Bania EV, Rasmussen LP, Ytreland K, Haug IM, Patras J, Sund AM, Martinsen K. Optimising indicated prevention for child anxiety and depression: A 12-month follow-up for cluster-randomised factorial 2 x 2 x 2 trial. J Child Adolesc Ment Health. 2026 Oct 11:1-20. doi: 10.2989/17280583.2026.2729473. Online ahead of print.

    PubMed 42859856

  • Martinsen KD, Aas E, Ingul JM, Lisoy C, Adolfsen F, Rasmussen LM, Wentzel-Larsen T, Neumer SP. Cost-effectiveness analysis of preventive strategies for child anxiety and depression: a health service perspective. Child Adolesc Psychiatry Ment Health. 2025 Oct 1;19(1):107. doi: 10.1186/s13034-025-00962-w.

    PubMed 41034930

  • Ytreland K, Bania EV, Lydersen S, Sund AM, Neumer SP, Adolfsen F, Martinsen KD, Rasmussen LP, Ingul JM. Parental Involvement in Child Anxiety and Depression: Exploring the Impact of Delivery Format on Modifiable Parental Factors. Child Psychiatry Hum Dev. 2025 Feb 13. doi: 10.1007/s10578-025-01814-6. Online ahead of print.

    PubMed 39946004

  • Haug IM, Neumer SP, Handegard BH, Lisoy C, Rasmussen LP, Bania EV, Adolfsen F, Patras J. Dose-Response Effects of MittEcho, a Measurement Feedback System, in an Indicated Mental Health Intervention for Children in Municipal and School Services in Norway. Adm Policy Ment Health. 2025 Jan;52(1):223-240. doi: 10.1007/s10488-024-01389-9. Epub 2024 May 29.

    PubMed 38809322

  • Lisoy C, Neumer SP, Adolfsen F, Ingul JM, Potulski Rasmussen LM, Wentzel-Larsen T, Patras J, Sund AM, Ytreland K, Waaktaar T, Holen S, Askeland AL, Haug IM, Bania EV, Martinsen K. Optimizing indicated cognitive behavioral therapy to prevent child anxiety and depression: A cluster-randomized factorial trial. Behav Res Ther. 2024 May;176:104520. doi: 10.1016/j.brat.2024.104520. Epub 2024 Mar 18.

    PubMed 38522127

  • Martinsen K, Lisoy C, Wentzel-Larsen T, Neumer SP, Rasmussen LP, Adolfsen F, Sund AM, Ingul JM. School children's mental health during the COVID-19 pandemic. Front Psychol. 2024 Jan 5;14:1290358. doi: 10.3389/fpsyg.2023.1290358. eCollection 2023.

    PubMed 38327509

Questions about this trial

What is this clinical trial studying?

A study testing Emotion child in people with Anxiety Depression, run by Regionsenter for barn og unges psykiske helse at 3 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Multidimensional Anxiety Scale (time frame: Time 1 baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04263558, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.

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