Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-02 @ 5:50 PM
Study NCT ID:
NCT04263558
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2019-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Echo: Optimizing a Group-based School Intervention for Children With Emotional Problems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1364}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2019-11-27', 'studyFirstSubmitQcDate': '2020-02-06', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Multidimensional Anxiety Scale', 'timeFrame': 'Time 1 baseline', 'description': 'Anxiety symptoms, minimum 0 to maximum 117, high score indicates worse outcome'}, {'measure': 'Multidimensional Anxiety Scale', 'timeFrame': 'Time 2 after approximal 10 weeks', 'description': 'Anxiety symptoms, minimum 0 to maximum 117, high score indicates worse outcome'}, {'measure': 'Multidimensional Anxiety Scale', 'timeFrame': 'Time 3 after approximal 1 year', 'description': 'Anxiety symptoms, minimum 0 to maximum 117, high score indicates worse outcome'}, {'measure': 'Mood and Feeling Questionnaire', 'timeFrame': 'Time 1 baseline', 'description': 'Depression symptoms, minimum 0 to maximum 26, high score indicates worse outcome'}, {'measure': 'Mood and Feeling Questionnaire', 'timeFrame': 'Time 2 after approximal 10 weeks', 'description': 'Depression symptoms, minimum 0 to maximum 26, high score indicates worse outcome'}, {'measure': 'Mood and Feeling Questionnaire', 'timeFrame': 'Time 3 after approximal one year', 'description': 'Depression symptoms, minimum 0 to maximum 26, high score indicates worse outcome'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety Depression']}, 'referencesModule': {'references': [{'pmid': '41034930', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '39946004', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '38809322', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '38522127', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '38327509', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Children scoring one standard deviation or more above population mean using established measures for anxiety and/or depression\n\nExclusion Criteria:\n\n* Retardation or language problems\n* Developmental conditions\n* Individual considerations approved by the local PI'}, 'identificationModule': {'nctId': 'NCT04263558', 'briefTitle': 'Echo: Optimizing a Group-based School Intervention for Children With Emotional Problems', 'organization': {'class': 'OTHER', 'fullName': 'Regionsenter for barn og unges psykiske helse'}, 'officialTitle': 'Echo: Optimizing a Group-based School Intervention for Children With Emotional Problems', 'orgStudyIdInfo': {'id': '31/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LHF', 'description': 'Long intervention (16 sessions) High parental involvement (5 sessions) Feedback', 'interventionNames': ['Behavioral: Emotion child']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LHN', 'description': 'Long intervention (16 sessions) High parental involvement (5 sessions)', 'interventionNames': ['Behavioral: Emotion child']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LLF', 'description': 'Long intervention (16 sessions) Low parental involvement (Brochure) Feedback', 'interventionNames': ['Behavioral: Emotion child']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LLN', 'description': 'Long intervention (16 sessions) Low parental involvement (Brochure)', 'interventionNames': ['Behavioral: Emotion child']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SHF', 'description': 'Short intervention (8 sessions, group) and 8 sessions web-based High parental involvement (5 sessions) Feedback', 'interventionNames': ['Behavioral: Emotion child']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SHN', 'description': 'Short intervention (8 sessions, group) and 8 sessions web-based High parental involvement (5 sessions)', 'interventionNames': ['Behavioral: Emotion child']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SLF', 'description': 'Short intervention (8 sessions, group) and 8 sessions web-based Low parental involvement (Brochure) Feedback', 'interventionNames': ['Behavioral: Emotion child']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SLN', 'description': 'Short intervention (8 sessions, group) and 8 sessions web-based Low parental involvement (Brochure)', 'interventionNames': ['Behavioral: Emotion child']}], 'interventions': [{'name': 'Emotion child', 'type': 'BEHAVIORAL', 'otherNames': ['Measurement Feedback System (MFS)', 'Emotion parent'], 'description': '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).', 'armGroupLabels': ['LHF', 'LHN', 'LLF', 'LLN', 'SHF', 'SHN', 'SLF', 'SLN']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0484', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Regionsenter for barn og unges psykiske helse', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '9037', 'city': 'Tromsø', 'country': 'Norway', 'facility': 'Regional kunnskapssenter for barn og unge - Nord', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}, {'zip': '7491', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'Regional kunnskapssenter for barn og unge - Midt', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Simon-Peter Neumer, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Child and Adolescent Mental Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regionsenter for barn og unges psykiske helse', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Tromso', 'class': 'OTHER'}, {'name': 'Technical University of Trondheim', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Phil.', 'investigatorFullName': 'Simon-Peter Neumer', 'investigatorAffiliation': 'Regionsenter for barn og unges psykiske helse'}}}}