Addressing Nonsuicidal Self-injury in Schools

July 4, 2023 updated by: Maria Zetterqvist, Region Östergötland
The aim of this study is to study the effectiveness of a whole-school approach that addresses non-suicidal self-injury and targets adolescents, parents and teachers. Whether training and interventions can influence NSSI will be examined. Furthermore, investigations will be conducted to examine whether this whole-school approach can reduce symptoms of mental health problems in adolescents, reduce stigma och increase help-seeking and perception of social support. Using a clustered waitlist control design, six lower secondary schools were randomized to either intervention or waitlist during four months (control groups were then given the intervention). Measures of NSSI, suicidality, mental well-being, stigma, attitudes, help-seeking and perceived social support were administered at baseline, after the intervention and at 6, 12 and 18-months follow-up. Two hundred and sixty-seven adolescents in seventh and eight grade participated in the study (135 active group and 132 control group). The interventions were delivered during four months. For adolescents, interventions were delivered in the class room and consisted of five sessions of the Youth Aware of Mental Health (YAM) program and one additional session focusing specifically on knowledge, stigma and attitudes toward NSSI (KRAS). Parents were offered an online psychoeducation on NSSI, as were all school staff during this time period. School health care personnel, nurses, psychologist and counsellors and other school staff, such as teachers' aids, support staff and mentors took part in a 2-day workshop on NSSI and suicidality.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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 (Actual)

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.
267

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 Locations

  • Sweden
    • Östergötland
      • Linköping, Östergötland, Sweden, 581 85
        • Linköping University

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

Yes

Description

Inclusion Criteria:

  • being a student in grade 7 and 8 in lower secondary school

Exclusion Criteria:

  • special classes for refugees recently arrived in Sweden with insufficient knowledge of the Swedish language
  • special classes for adolescents with intellectual disability

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: Parallel 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: Addressing NSSI in schools
During the four months of active experimental condition, adolescents receive five sessions of the youth aware of mental health program in the class room, and one additional session on NSSI. Parents and school staff receive an online psychoeducation on NSSI. School health care personnel receive a 2-day workshop on NSSI and suicidality.
Behavioral: Addressing NSSI in schools
During the four months of active experimental condition, adolescents receive five sessions of the youth aware of mental health program in the class room, and one additional session on NSSI. Parents and school staff receive an online psychoeducation on NSSI. School health care personnel receive a 2-day workshop on NSSI and suicidality.
Other: Control condition
Participating adolescents, parents, teachers and school health care personnel receive no intervention during four months
Other: Control condition
Participating adolescents, parents, teachers and health care personnel receive no intervention during four months

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
Life-time prevalence of nonsuicidal self-injury
Time Frame: Change from baseline at 4 months and at 6, 12 and 18 months
Change in self-reported life-time prevalence of nonsuicidal self-injury is measured with a single-item (yes/no) from the Self-Injurious Thoughts and Behaviors Interview Self-Report Short-Form (SITBI-SR-SF).
Change from baseline at 4 months and at 6, 12 and 18 months
Frequency of nonsuicidal self-injury
Time Frame: Change from baseline at 4 months and at 6, 12 and 18 months
Change in self-reported frequency of nonsuicidal self-injury (NSSI) is measured with NSSI checklist from the Inventory of Statements About Self-injury (ISAS). Number of NSSI incidence is registered from 0 to the highest number that participants rate. High scores indicate more frequent NSSI.
Change from baseline at 4 months and at 6, 12 and 18 months

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
Health-related quality of life
Time Frame: Change from baseline at 4 months and at 6, 12 and 18 months
Change in self-reported health-related quality of life (HRQOL) is measured with the 52-item version of the kid screen (KIDSCREEN 52), a self-report measure that measures the subjective HRQOL in children and adolescents between the ages of 8 and 18. KIDSCREEN 52 questionnaire consisted of 52 items assessing ten HRQOL dimensions. The KIDSCREEN-52 HRQOL questionnaire assesses the frequency of behavior/feelings or and use a 5-point Likert response scale. Scores are computed for each dimension and are transformed into T-values with a mean of 50 and a standard deviation of 10. Higher scores indicate higher HRQOL.
Change from baseline at 4 months and at 6, 12 and 18 months
nonsuicidal self-injury expectancy
Time Frame: Change from baseline at 4 months and at 6, 12 and 18 months
Change in self-reported nonsuicidal self-injury expectancy is measured with the Non-Suicidal Self-Injury Expectancy Questionnaire (NEQ), which is a self-report measure that measures attitudes and expectancy to own and others' NSSI. A shortened 10-item version was used with items scored on a 4-point Likert scale, ranging from 10 to 40, with higher scores indicating higher endorsement of NSSI expectancies.
Change from baseline at 4 months and at 6, 12 and 18 months
Perceived Social Support
Time Frame: Change from baseline at 4 months and at 6, 12 and 18 months
Change in self-reported perceived social support was measured using the Multidimensional Scale of Perceived Social Support, which is a self-report scale that measures perceived social support. It contains 12 items and is scored on a 7-point Likert scale with total scores ranging from 12 to 84, with higher scores indicating higher levels of perceived social support.
Change from baseline at 4 months and at 6, 12 and 18 months
Stigma
Time Frame: Change from baseline at 4 months and at 6, 12 and 18 months
Change in self-reported stigma is measures with the Mental Health Stigmatization Scale-Revised (PMHSS-R). PMHSS-R assess perceptions of stigma awareness and agreement related to mental-health in peers. The subscales include six and five items rated on a five-point Likert scale (1 = disagree completely, 5 = agree completely). An individual score is generated by adding up all items of each subscale, which ranges from 6 to 30 (awareness) and 5 to 25 (agreement). Higher scores indicate higher levels of stigma agreement and stigma awareness, that is, higher levels of mental health related stigmatizing attitudes.
Change from baseline at 4 months and at 6, 12 and 18 months
Help-seeking
Time Frame: Change from baseline at 4 months and at 6, 12 and 18 months
Change in self-reported help-seeking is measured with Help-Seeking Acceptability at School, Adult Help for Suicidal Youth and Reject Codes of Silence, which is a self-report measure that assesses attitudes toward seeking help from adults in three domains: "Help seeking acceptability", "Adult help for suicidal youth" and "Reject Codes of Silence". The total score includes 11 items which are scored on a 4-point Likert scale. Scores range from 4 to 16 (help-seeking acceptability); 3 to 12 (Adult help), and 3 to 12 (rejecting codes of silence). Higher scores indicate better outcome and a more positive attitude to help-seeking.
Change from baseline at 4 months and at 6, 12 and 18 months
Suicidal ideation
Time Frame: Change from baseline at 4 months and at 6, 12 and 18 months
Change in self-reported suicidal ideation is assessed with the Self-Injurious Thoughts and Behaviors Interview Self-Report Short-Form (SITBI-SR-SF) as single-item assessment of prevalence yes/no.
Change from baseline at 4 months and at 6, 12 and 18 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difficulties in emotion regulation
Time Frame: Change from baseline at 4 months and at 6, 12 and 18 months
Changes in self-reported difficulties in emotion regulation is measures with the 16-item version of the Difficulties in Emotion Regulation Scale (DERS-16). Total scores range from 16 to 80 with higher scores indicating higher levels of difficulties in emotion regulation.
Change from baseline at 4 months and at 6, 12 and 18 months
Self-criticism
Time Frame: Change from baseline at 4 months and at 6, 12 and 18 months
Change in self-reported self-criticism is measures using the Self-Rating Scale (SRS), which is a self-report measure to assess self-criticism. It contains of 8 items which are scored on a 7-point Likert scale. The total scale ranges from 8 to 56 with higher scores indicating higher levels of self-criticism.
Change from baseline at 4 months and at 6, 12 and 18 months

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.
Region Östergötland

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: Maria A Zetterqvist, PhD, CSAN, BKV, Linköping university

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.

General Publications

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 (Actual)

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.
January 10, 2022

Primary Completion (Actual)

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.
June 12, 2023

Study Completion (Actual)

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.
June 12, 2023

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).
April 30, 2023

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.
July 4, 2023

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.
July 7, 2023

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.
July 7, 2023

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.
July 4, 2023

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.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 2021-01699

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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