NCT07000799

Brief Summary

This study will be conducted at elementary schools in Oslo and aims to explore multiple aspects of school absenteeism and student well-being. It has two main objectives: 1) a preventive focus specifically related to school attendance and functioning, and 2) a user perspective that includes measuring user satisfaction with the interventions used in the study. The aim is to investigate whether the EMOTION intervention can be utilized to enhance school attendance and functioning for children experiencing emerging difficulties in attending school, who also tend to be more sad and anxious than their peers. Additionally, the study seeks to compare changes in anxiety and sadness with previous studies involving the EMOTION intervention through benchmarking. The perceptions of parents regarding the causes of their children's difficulties will also be examined. Evaluating user satisfaction with the EMOTION intervention in relation to emerging school absenteeism and the implementation of attendance teams in the schools is another objective. This will contribute to increased knowledge about interventions targeting children with emerging difficulties in school attendance and their experiences with these interventions.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Mar 2025Dec 2026

Study Start

First participant enrolled

March 28, 2025

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 3, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

1.8 years

First QC Date

April 24, 2025

Last Update Submit

May 22, 2025

Conditions

Keywords

school absenteismanxietydepressionPreventionEarly intervention

Outcome Measures

Primary Outcomes (1)

  • Primar outcomes for absenteeism

    Primary outcome measures Children: School attendance: Screen for Early Development of School Absenteeism: SCREEN. Scores from 1 - 5 , not at all to very, higher score indicates higher absentism. Primary outcome measures Parents: Screen for Early Development of School Absenteeism: SCRE

    From screening for enrollment (T1), at the end of treatment after approximately 10 weeks (T2) and 6 moths after the intervention finished (T3)

Study Arms (1)

Intervention arm with new groups entering the intervention every semester

EXPERIMENTAL

The design is a single arm pre-post design where the children will receive the EMOTION intervention over 8 weeks and attendance teams will be implemented in their school. The EMOTION Intervention is based on cognitive-behavioral therapy, which has been shown to be effective in both the treatment and prevention of anxiety and depression in children. The EMOTION intervention has been developed as a school-based program and consists of an intensive course lasting eight weeks, using a hybrid model with eight face-to-face group meetings at school and eight hours of digital sessions completed by the child at home. Additionally, it is desirable for parents to support their children; hence, guardians will be offered the opportunity to attend an informational meeting. They will also receive a brochure detailing how they can support and assist their child. A group leader manual and a workbook for the children have been developed (Martinsen et al., 2017). In the children's groups, participants

Behavioral: CBT

Interventions

CBTBEHAVIORAL

The EMOTION Intervention is based on cognitive-behavioral therapy, which has been shown to be effective in both the treatment and prevention of anxiety and depression in children. The EMOTION intervention has been developed as a school-based program and consists of an intensive course lasting eight weeks, using a hybrid model with eight face-to-face group meetings at school and eight hours of digital sessions completed by the child at home. Additionally, it is desirable for parents to support their children; hence, guardians will be offered the opportunity to attend an informational meeting. They will also receive a brochure detailing how they can support and assist their child. A group leader manual and a workbook for the children have been developed (Martinsen et al., 2017).

Intervention arm with new groups entering the intervention every semester

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children wherer the child or parents report difficulties related to school participation/functioning
  • and who exhibit elevated symptom levels for self-reported anxiety and/or sadness RCADS - 47

You may not qualify if:

  • Children who are deemed not to benefit from a group intervention includeing children with low cognitive capacity or with developmental disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oslo

Oslo, 0473, Norway

Location

Related Publications (1)

  • Martinsen KD, Rasmussen LMP, Wentzel-Larsen T, Holen S, Sund AM, Lovaas MES, Patras J, Kendall PC, Waaktaar T, Neumer SP. Prevention of anxiety and depression in school children: Effectiveness of the transdiagnostic EMOTION program. J Consult Clin Psychol. 2019 Feb;87(2):212-219. doi: 10.1037/ccp0000360. Epub 2018 Dec 13.

    PMID: 30550301BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Kristin D. Martinsen, PhD

    UiO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Psychology, PhD

Study Record Dates

First Submitted

April 24, 2025

First Posted

June 3, 2025

Study Start

March 28, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

June 3, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

At this time, we do not have definitive plans to share Individual Participant Data (IPD) with other researchers due to several considerations. Firstly, we are committed to maintaining participant confidentiality and adhering to data protection regulations, which may restrict the international sharing of data. Additionally, the study still in its early stages, and we are assessing the feasibility and ethical implications of data sharing as the project progresses. We recognize the importance of data sharing for advancing research and may explore opportunities for future collaboration that align with ethical guidelines and regulatory requirements. Should circumstances change, we will develop a transparent sharing plan that ensures compliance with applicable laws and safeguards participant confidentiality.

Locations