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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participants must be between the ages of 9 and 15 at the time of enrollment.
  2. Participants must have less than 80% attendance for the last 12 weeks of school at the time of screening.
  3. At least one parent has to talk and understand Norwegian.
  4. At least one parent has to be motivated to participate.
  5. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Direct intervention
Participants randomized to this intervention will receive the 13 week intervention Back2School starting immediately after randomization.
Behavioral: Back2School
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
Behavioral: Back2School
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
Measures perceived quality of life as reported by parents and child using Kidscreen 10
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)
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)
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)
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)
Change in symptoms of depression reported by child and parents using the SMFQ
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Norwegian University of Science and Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Bergen
University of Tromso
The Research Council of Norway
University of Aarhus
NORCE Norwegian Research Centre AS
University of Stavanger
Regionsenter for barn og unges psykiske helse
Regionalt kunnskapssenter for barn og unge - Nord

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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