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Nonsuicidal Self-injuryNCT05935345

Addressing Nonsuicidal Self-injury in Schools

A study testing Addressing NSSI in schools in people with Nonsuicidal Self-injury and Suicidal Ideation, run by Region Östergötland at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 13 to 15 yearsHealthy volunteers can take part
What is being tested?
Addressing NSSI in schools
Could I receive a placebo?
No, everyone receives an active treatment
How many people
267 participants
Where
1 siteSweden
Study dates
10 Jan 2022to 12 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Linköping university

    Linköping, Östergötland County, 581 85

Other trials in Sweden

About this study

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.

Being tested
Addressing NSSI in schools, Control condition
Keywords
Prevention, Whole-school approach, Nonsuicidal self-injury, Suicidality, Stigma, Help-seeking, Mental health
Medical subject headings
Self-Injurious Behavior, Suicidal Ideation, Stereotyping, Help-Seeking Behavior, Psychological Well-Being, Social Stigma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Addressing NSSI in schoolsBehavioural

    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.

  • Control conditionOther

    Participating adolescents, parents, teachers and health care personnel receive no intervention during four months

Study groups in NCT05935345
Study groupRoleWhat they receive
Addressing NSSI in schoolsExperimentalDuring 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.
Receives: Behavioral: Addressing NSSI in schools
Control conditionOtherParticipating adolescents, parents, teachers and school health care personnel receive no intervention during four months
Receives: Other: Control condition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Life-time prevalence of nonsuicidal self-injury

    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).

    Measured: Change from baseline at 4 months and at 6, 12 and 18 months

  2. Frequency of nonsuicidal self-injury

    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.

    Measured: Change from baseline at 4 months and at 6, 12 and 18 months

Secondary outcomes (6)

  1. Health-related quality of life

    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.

    Measured: Change from baseline at 4 months and at 6, 12 and 18 months

  2. nonsuicidal self-injury expectancy

    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.

    Measured: Change from baseline at 4 months and at 6, 12 and 18 months

  3. Perceived Social Support

    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.

    Measured: Change from baseline at 4 months and at 6, 12 and 18 months

  4. Stigma

    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.

    Measured: Change from baseline at 4 months and at 6, 12 and 18 months

  5. Help-seeking

    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.

    Measured: Change from baseline at 4 months and at 6, 12 and 18 months

  6. Suicidal ideation

    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.

    Measured: Change from baseline at 4 months and at 6, 12 and 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2023
  2. Study start10 Jan 2022
  3. Primary completion12 Jun 2023
  4. Study completion12 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
267 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05935345
Sponsor's protocol ID
2021-01699
Status last verified
Jul 2023
First submitted
30 Apr 2023
Last updated
7 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bjureberg J, Ljotsson B, Tull MT, Hedman E, Sahlin H, Lundh LG, Bjarehed J, DiLillo D, Messman-Moore T, Gumpert CH, Gratz KL. Development and Validation of a Brief Version of the Difficulties in Emotion Regulation Scale: The DERS-16. J Psychopathol Behav Assess. 2016 Jun;38(2):284-296. doi: 10.1007/s10862-015-9514-x. Epub 2015 Sep 14.

    PubMed 27239096

  • Hooley JM, Ho DT, Slater J, Lockshin A. Pain perception and nonsuicidal self-injury: a laboratory investigation. Personal Disord. 2010 Jul;1(3):170-9. doi: 10.1037/a0020106.

    PubMed 22448633

  • Klonsky ED, Glenn CR. Assessing the functions of non-suicidal self-injury: Psychometric properties of the Inventory of Statements About Self-injury (ISAS). J Psychopathol Behav Assess. 2009 Sep;31(3):215-219. doi: 10.1007/s10862-008-9107-z. Epub 2008 Oct 30.

    PubMed 29269992

  • McKeague L, Hennessy E, O'Driscoll C, Heary C. Peer Mental Health Stigmatization Scale: psychometric properties of a questionnaire for children and adolescents. Child Adolesc Ment Health. 2015 Sep;20(3):163-170. doi: 10.1111/camh.12088. Epub 2015 Feb 16.

    PubMed 32680400

  • Nearchou F, O'Driscoll C, McKeague L, Heary C, Hennessy E. Psychometric properties of the Peer Mental Health Stigmatization Scale-Revised in adolescents and young adults. Early Interv Psychiatry. 2021 Feb;15(1):201-205. doi: 10.1111/eip.12933. Epub 2020 Feb 9.

    PubMed 32037717

  • Nock MK, Holmberg EB, Photos VI, Michel BD. Self-Injurious Thoughts and Behaviors Interview: development, reliability, and validity in an adolescent sample. Psychol Assess. 2007 Sep;19(3):309-17. doi: 10.1037/1040-3590.19.3.309.

    PubMed 17845122

  • Ravens-Sieberer U, Gosch A, Rajmil L, Erhart M, Bruil J, Duer W, Auquier P, Power M, Abel T, Czemy L, Mazur J, Czimbalmos A, Tountas Y, Hagquist C, Kilroe J, Kidscreen Group E. KIDSCREEN-52 quality-of-life measure for children and adolescents. Expert Rev Pharmacoecon Outcomes Res. 2005 Jun;5(3):353-64. doi: 10.1586/14737167.5.3.353.

    PubMed 19807604

  • Wyman PA, Brown CH, Inman J, Cross W, Schmeelk-Cone K, Guo J, Pena JB. Randomized trial of a gatekeeper program for suicide prevention: 1-year impact on secondary school staff. J Consult Clin Psychol. 2008 Feb;76(1):104-15. doi: 10.1037/0022-006X.76.1.104.

    PubMed 18229988

  • Zetterqvist M, Lundh LG, Dahlstrom O, Svedin CG. Prevalence and function of non-suicidal self-injury (NSSI) in a community sample of adolescents, using suggested DSM-5 criteria for a potential NSSI disorder. J Abnorm Child Psychol. 2013 Jul;41(5):759-73. doi: 10.1007/s10802-013-9712-5.

    PubMed 23344701

  • Hasking P, Boyes M. The Non-Suicidal Self-Injury Expectancy Questionnaire: Factor structure and initial validation. Clinical Psychologist. 2018;22(2):251-261. doi:10.1111/cp.12127

  • Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095.

    PubMed 2280326

Questions about this trial

What is this clinical trial studying?

A study testing Addressing NSSI in schools in people with Nonsuicidal Self-injury and Suicidal Ideation, run by Region Östergötland at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Life-time prevalence of nonsuicidal self-injury (time frame: Change from baseline at 4 months and at 6, 12 and 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05935345, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023; AzTrials last refreshed its copy on 26 Oct 2026.

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