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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05935345
Other study ID # 2021-01699
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2022
Est. completion date June 12, 2023

Study information

Verified date July 2023
Source Region Östergötland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 267
Est. completion date June 12, 2023
Est. primary completion date June 12, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 15 Years
Eligibility 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 Design


Intervention

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 health care personnel receive no intervention during four months

Locations

Country Name City State
Sweden Linköping university Linköping Östergötland

Sponsors (1)

Lead Sponsor Collaborator
Region Östergötland

Country where clinical trial is conducted

Sweden, 

References & 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. — View 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

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Difficulties in emotion regulation 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
Other Self-criticism 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
Primary 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
Primary 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 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. Change from baseline at 4 months and at 6, 12 and 18 months
Secondary 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. Change from baseline at 4 months and at 6, 12 and 18 months
Secondary 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. Change from baseline at 4 months and at 6, 12 and 18 months
Secondary 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. Change from baseline at 4 months and at 6, 12 and 18 months
Secondary 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. Change from baseline at 4 months and at 6, 12 and 18 months
Secondary 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. Change from baseline at 4 months and at 6, 12 and 18 months
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