search
Back to results

Addressing Nonsuicidal Self-injury in Schools

Primary Purpose

Nonsuicidal Self-injury, Suicidal Ideation, Stigmatization

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Addressing NSSI in schools
Control condition
Sponsored by
Region Östergötland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nonsuicidal Self-injury focused on measuring Prevention, Whole-school approach, Nonsuicidal self-injury, Suicidality, Stigma, Help-seeking, Mental health

Eligibility Criteria

13 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Linköping university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Addressing NSSI in schools

Control condition

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 30, 2023
Last Updated
July 4, 2023
Sponsor
Region Östergötland
search

1. Study Identification

Unique Protocol Identification Number
NCT05935345
Brief Title
Addressing Nonsuicidal Self-injury in Schools
Official Title
Addressing Nonsuicidal Self-injury in Schools
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
June 12, 2023 (Actual)
Study Completion Date
June 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Östergötland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonsuicidal Self-injury, Suicidal Ideation, Stigmatization, Help-Seeking Behavior, Perceived Social Support, Mental Well-being
Keywords
Prevention, Whole-school approach, Nonsuicidal self-injury, Suicidality, Stigma, Help-seeking, Mental health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Addressing NSSI in schools
Arm Type
Experimental
Arm Description
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.
Arm Title
Control condition
Arm Type
Other
Arm Description
Participating adolescents, parents, teachers and school health care personnel receive no intervention during four months
Intervention Type
Behavioral
Intervention Name(s)
Addressing NSSI in schools
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control condition
Intervention Description
Participating adolescents, parents, teachers and health care personnel receive no intervention during four months
Primary Outcome Measure Information:
Title
Life-time prevalence of nonsuicidal self-injury
Description
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).
Time Frame
Change from baseline at 4 months and at 6, 12 and 18 months
Title
Frequency of nonsuicidal self-injury
Description
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.
Time Frame
Change from baseline at 4 months and at 6, 12 and 18 months
Secondary Outcome Measure Information:
Title
Health-related quality of life
Description
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.
Time Frame
Change from baseline at 4 months and at 6, 12 and 18 months
Title
nonsuicidal self-injury expectancy
Description
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.
Time Frame
Change from baseline at 4 months and at 6, 12 and 18 months
Title
Perceived Social Support
Description
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.
Time Frame
Change from baseline at 4 months and at 6, 12 and 18 months
Title
Stigma
Description
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.
Time Frame
Change from baseline at 4 months and at 6, 12 and 18 months
Title
Help-seeking
Description
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.
Time Frame
Change from baseline at 4 months and at 6, 12 and 18 months
Title
Suicidal ideation
Description
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.
Time Frame
Change from baseline at 4 months and at 6, 12 and 18 months
Other Pre-specified Outcome Measures:
Title
Difficulties in emotion regulation
Description
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.
Time Frame
Change from baseline at 4 months and at 6, 12 and 18 months
Title
Self-criticism
Description
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.
Time Frame
Change from baseline at 4 months and at 6, 12 and 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria A Zetterqvist, PhD
Organizational Affiliation
CSAN, BKV, Linköping university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linköping university
City
Linköping
State/Province
Östergötland
ZIP/Postal Code
581 85
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27239096
Citation
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.
Results Reference
background
PubMed Identifier
22448633
Citation
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.
Results Reference
background
PubMed Identifier
29269992
Citation
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.
Results Reference
background
PubMed Identifier
32680400
Citation
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.
Results Reference
background
PubMed Identifier
32037717
Citation
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.
Results Reference
background
PubMed Identifier
17845122
Citation
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.
Results Reference
background
PubMed Identifier
19807604
Citation
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.
Results Reference
background
PubMed Identifier
18229988
Citation
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.
Results Reference
background
PubMed Identifier
23344701
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
2280326
Citation
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.
Results Reference
background

Learn more about this trial

Addressing Nonsuicidal Self-injury in Schools

We'll reach out to this number within 24 hrs