- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05935345
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
267
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 Locations
-
-
Östergötland
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Linköping, Östergötland, Sweden, 581 85
- Linköping University
-
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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
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 |
Intervention / Treatment |
---|---|
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.
|
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
|
Participating adolescents, parents, teachers and health care personnel receive no intervention during four months
|
What is the study measuring?
Primary Outcome Measures
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
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.
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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
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.
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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
Investigators
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
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)
January 10, 2022
Primary Completion (Actual)
June 12, 2023
Study Completion (Actual)
June 12, 2023
Study Registration Dates
First Submitted
April 30, 2023
First Submitted That Met QC Criteria
July 4, 2023
First Posted (Actual)
July 7, 2023
Study Record Updates
Last Update Posted (Actual)
July 7, 2023
Last Update Submitted That Met QC Criteria
July 4, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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