- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07463001
Optimization and Testing Effectiveness of a Collaborative Intervention for School Attendance Problems in Norwegian Municipalities
March 6, 2026 updated by: Norwegian University of Science and Technology
In this study we will investigate the effects of an intervention called Back2School, revised and adapted for Norwegian conditions on school attendance.
A total of 240 participants will be recruited.
All participants who have been enrolled will receive the intervention.
Half of the participants will receive the intervention without delay (the experiment group), and the other half will receive it following a 13-week period (the control group).
Following consent, screening for eligibility and randomization, the intervention will start with an assessment related to the individual participant and condition at the participants' school.
Based on this a shared understanding and an intervention plan is developed.
Over a 13-week period the youth, the family and the school, work together guided by the municipal team to increase attendance and solve problems related to this.
Assessments will be carried out after the intervention and 6 months later.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jo M Ingul, phd
- Phone Number: +4792869163
- Email: jo.m.ingul@ntnu.no
Study Contact Backup
- Name: Kristin Ytreland, phd
- Email: kristin.ytreland@ntnu.no
Study Locations
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-
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Bergen, Norway
- NORCE, RKBU Vest
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Contact:
- Kristin G Askeland, phd
- Phone Number: +47 56 10 72 05
- Email: kras@norceresearch.no
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Contact:
- Marit H Larsen, phd
- Email: mala@norceresearch.no
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Oslo, Norway
- Pilar, Regionsenter for barn og unges psykiske helse
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Contact:
- Simon P Neumer, phd
- Phone Number: +4795820508
- Email: simon-peter.neumer@r-bup.no
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Contact:
- Carina Lisøy, phd
- Email: carina.lisoy@r-bup.no
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Tromsø, Norway
- UIT, RKBU Nord
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Contact:
- Frode Adolfsen, phd
- Phone Number: +4791126323
- Email: frode.adolfsen@ntnu.no
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Contact:
- Therese B Halvorsen
- Email: therese.halvorsen@uit.no
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Trondheim, Norway
- Norwegian University of Scinece and Technology
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Contact:
- Jo M Ingul, phd
- Phone Number: +4792869163
- Email: jo.m.ingul@ntnu.no
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Contact:
- Elisabeth Valmyr Bania, phd
- Email: elisabeth.bania@ntnu.no
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Participants must be between the ages of 9 and 15 at the time of enrollment.
- Participants must have less than 80% attendance for the last 12 weeks of school at the time of screening.
- At least one parent has to talk and understand Norwegian.
- At least one parent has to be motivated to participate.
- The school must agree to participate in the intervention
Exclusion Criteria:
1 The participant has a known diagnosis of autism-spectrum disorder, psychosis, and/or eating disorder.
2. Participant needs acute psychiatric intervention.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Direct intervention
Participants randomized to this intervention will receive the 13 week intervention Back2School starting immediately after randomization.
|
The revised Back2S school manual consists of an initial assessment, a case formulation conference, 16 sessions and 3 meetings with different participants (parents, youth, school personnel) over 13 weeks.
There is a booster session 12 weeks after the final session and one 24 weeks after the final session.
|
|
Other: Delayed intervention/ Wait list control
Participants randomized to delayed intervention will ha to wait for 13-15 weeks following randomization before the intervention is started.
During the waiting phase they can receive treatment as usual
|
The revised Back2S school manual consists of an initial assessment, a case formulation conference, 16 sessions and 3 meetings with different participants (parents, youth, school personnel) over 13 weeks.
There is a booster session 12 weeks after the final session and one 24 weeks after the final session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
School attendance
Time Frame: Direct: Avg at Baseline, 2 weeks at end (13 weeks from baseline), 2 weeks at 6 months (37 w from baseline) Delayed: Avg at baseline, 2 weeks before start (13 w from baseline) 2 weeks at end (28 w from baseline), 2 weeks at 6 months (54 w from baseline)
|
School attendance measured on a daily basis by teacher.
|
Direct: Avg at Baseline, 2 weeks at end (13 weeks from baseline), 2 weeks at 6 months (37 w from baseline) Delayed: Avg at baseline, 2 weeks before start (13 w from baseline) 2 weeks at end (28 w from baseline), 2 weeks at 6 months (54 w from baseline)
|
|
General functioning
Time Frame: Direct start group: Will be measured at Baseline (T1), Week 15 from baseline (T2), Week 37 from baseline (T3) Delayed access group: Baseline (T1), Week 15 from Baseline (T1a), Week 29 from baseline (T2), Week 54 from baseline (T3)
|
Impact on daily life as measured by the SDQ impact scale
|
Direct start group: Will be measured at Baseline (T1), Week 15 from baseline (T2), Week 37 from baseline (T3) Delayed access group: Baseline (T1), Week 15 from Baseline (T1a), Week 29 from baseline (T2), Week 54 from baseline (T3)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Quality of life
Time Frame: Direct start group: Will be measured at Baseline (T1), Week 15 from baseline (T2), Week 37 from baseline (T3) Delayed access group: Baseline (T1), Week 15 from Baseline (T1a), Week 29 from baseline (T2), Week 54 from baseline (T3)
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Measures perceived quality of life as reported by parents and child using Kidscreen 10
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Direct start group: Will be measured at Baseline (T1), Week 15 from baseline (T2), Week 37 from baseline (T3) Delayed access group: Baseline (T1), Week 15 from Baseline (T1a), Week 29 from baseline (T2), Week 54 from baseline (T3)
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Change in symptoms of anxiety
Time Frame: Direct start group: Will be measured at Baseline (T1), Week 15 from baseline (T2), Week 37 from baseline (T3) Delayed access group: Baseline (T1), Week 15 from Baseline (T1a), Week 29 from baseline (T2), Week 54 from baseline (T3)
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Measures change in symptoms of anxiety as measured by the SCAS reported by parents and child
|
Direct start group: Will be measured at Baseline (T1), Week 15 from baseline (T2), Week 37 from baseline (T3) Delayed access group: Baseline (T1), Week 15 from Baseline (T1a), Week 29 from baseline (T2), Week 54 from baseline (T3)
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|
Change in symptoms of Depression
Time Frame: Direct start group: Will be measured at Baseline (T1), Week 15 from baseline (T2), Week 37 from baseline (T3) Delayed access group: Baseline (T1), Week 15 from Baseline (T1a), Week 29 from baseline (T2), Week 54 from baseline (T3)
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Change in symptoms of depression reported by child and parents using the SMFQ
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Direct start group: Will be measured at Baseline (T1), Week 15 from baseline (T2), Week 37 from baseline (T3) Delayed access group: Baseline (T1), Week 15 from Baseline (T1a), Week 29 from baseline (T2), Week 54 from baseline (T3)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jo Magne Ingul, phd, Norwegian University of Science and Technology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 23, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
March 1, 2029
Study Registration Dates
First Submitted
February 26, 2026
First Submitted That Met QC Criteria
March 6, 2026
First Posted (Actual)
March 10, 2026
Study Record Updates
Last Update Posted (Actual)
March 10, 2026
Last Update Submitted That Met QC Criteria
March 6, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 353222
- 907476 (Other Identifier: REK MIDT-NORGE)
- 658505 (Other Identifier: SIKT)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Not allowed by Norwegian law and therefore not allowed by our ethical board
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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