NCT05935345

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
267

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

1.4 years

First QC Date

April 30, 2023

Last Update Submit

July 4, 2023

Conditions

Keywords

PreventionWhole-school approachNonsuicidal self-injurySuicidalityStigmaHelp-seekingMental health

Outcome Measures

Primary Outcomes (2)

  • 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).

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

  • 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.

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

Secondary Outcomes (6)

  • Health-related quality of life

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

  • nonsuicidal self-injury expectancy

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

  • Perceived Social Support

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

  • Stigma

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

  • Help-seeking

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

  • +1 more secondary outcomes

Other Outcomes (2)

  • Difficulties in emotion regulation

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

  • Self-criticism

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

Study Arms (2)

Addressing NSSI in schools

EXPERIMENTAL

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

Control condition

OTHER

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

Other: Control condition

Interventions

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.

Addressing NSSI in schools

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

Control condition

Eligibility Criteria

Age13 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linköping university

Linköping, Östergötland County, 581 85, Sweden

Location

Related Publications (11)

  • 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.

    PMID: 27239096BACKGROUND
  • 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.

    PMID: 22448633BACKGROUND
  • 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.

    PMID: 29269992BACKGROUND
  • 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.

    PMID: 32680400BACKGROUND
  • 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.

    PMID: 32037717BACKGROUND
  • 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.

    PMID: 17845122BACKGROUND
  • 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.

    PMID: 19807604BACKGROUND
  • 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.

    PMID: 18229988BACKGROUND
  • 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.

    PMID: 23344701BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 2280326BACKGROUND

MeSH Terms

Conditions

Self-Injurious BehaviorSuicidal IdeationStereotypingHelp-Seeking BehaviorPsychological Well-BeingSocial Stigma

Interventions

Schools

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSuicideSocial BehaviorPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities

Study Officials

  • Maria A Zetterqvist, PhD

    CSAN, BKV, Linköping university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 30, 2023

First Posted

July 7, 2023

Study Start

January 10, 2022

Primary Completion

June 12, 2023

Study Completion

June 12, 2023

Last Updated

July 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations