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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04003675
Other study ID # 2019/FO244849
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2019
Est. completion date October 12, 2021

Study information

Verified date November 2021
Source Norwegian School of Sport Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study examines sexual harassment and abuse in and outside sports among adolescent elite athlete boys and girls, adolescent control students, trainers and leaders at elite sport high schools and regular high schools in Norway.


Description:

The purpose of the study is to examine the prevalence and outcome of sexual harassment within and outside sports, including who the perpetrators are, the association between experienced sexual harassment and psychological health, knowledge of report mechanisms and emergency plans, and the participants suggestions for preventive strategies. The knowledge from this study will be a good basis to establish and implement prevention strategies and educational programs in the future. Students, trainers (with more than 20 % employment status) and leaders at elite sport high schools and regular high schools in Norway will answer a questionnaire at two measurement points. Additionally, a sample of randomly selected students who report experiences with sexual harassment, and a random sample of trainers and leaders, will be invited to participate in an individual in-depth interview. Students scoring above cut-off on the questionnaire measuring symptoms of eating disorders (EDE-q) will be invited to a separate diagnostic interview (EDE). A group of students will also participate in a test-retest examination of the reliability of the questionnaire.


Recruitment information / eligibility

Status Completed
Enrollment 1250
Est. completion date October 12, 2021
Est. primary completion date October 12, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - Over 16 years of age - Students in 2nd grade elite sport high schools in Norway - Students in 2nd grade at regular high schools (no specialization) in Viken and Oslo in Norway - Trainers with more than 20 percent employment status at elite sport highs schools - Leaders/principles at the attending elite sport- and regular high schools Exclusion Criteria: - Students under 16 years of age - Trainers with less than 20 percent employment status - Students/trainers not understanding written Norwegian language

Study Design


Locations

Country Name City State
Norway Norwegian school of sport sciences Oslo

Sponsors (6)

Lead Sponsor Collaborator
Norwegian School of Sport Sciences Norwegian Extra Foundation for Health and Rehabilitation, The Norwegian Women´s Public Health Association, UiT The Arctic University of Norway, University of Agder, University of Toronto

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sexual harassment Adolescent elite athletes and controls will answer a self-reported questionnaire regarding prevalence of sexual harassment, awareness of reporting mechanisms and emergency plans, suggestions for how to prevent sexual harassment. Baseline
Primary Sexual harassment Adolescent elite athletes and controls will answer a self-reported questionnaire regarding prevalence of sexual harassment, awareness of reporting mechanisms and emergency plans, suggestions for how to prevent sexual harassment. 1 year after baseline
Primary Sexual harassment Adolescent elite athletes and controls will answer a self-reported questionnaire regarding prevalence of sexual harassment, awareness of reporting mechanisms and emergency plans, suggestions for how to prevent sexual harassment. Two weeks (test-retest)
Secondary Symptoms of eating disorders Adolescent elite athletes and controls will answer the self-reported questionnaire "Eating Disorder Examination Questionnaire-6". The questionnaire consists of 28 items measuring symptoms and severity of eating disorders. Baseline
Secondary Symptoms of eating disorders Adolescent elite athletes and controls will answer the self-reported questionnaire "Eating Disorder Examination Questionnaire-6". The questionnaire consists of 28 items measuring symptoms and severity of eating disorders. 1 year after baseline
Secondary Symptoms of eating disorders Adolescent elite athletes and controls will answer the self-reported questionnaire "Eating Disorder Examination Questionnaire-6". The questionnaire consists of 28 items measuring symptoms and severity of eating disorders. Two weeks (test-retest)
Secondary Health related quality of life Adolescent elite athletes and controls will answer two questions from the self-reported questionnaire "The World Health Organization Quality of Life Assessment Instrument" (WHOQOL-BREF). The items measure overall perception of quality of life and overall satisfaction with own health during the last two weeks on a 5-point Likert-scale ranging from very poor/very dissatisfied to very good/very satisfied. Baseline
Secondary Health related quality of life Adolescent elite athletes and controls will answer two questions from the self-reported questionnaire "The World Health Organization Quality of Life Assessment Instrument" (WHOQOL-BREF). The items measure overall perception of quality of life and overall satisfaction with own health during the last two weeks on a 5-point Likert-scale ranging from very poor/very dissatisfied to very good/very satisfied. 1 year after baseline
Secondary Health related quality of life Adolescent elite athletes and controls will answer two questions from the self-reported questionnaire "The World Health Organization Quality of Life Assessment Instrument" (WHOQOL-BREF). The items measure overall perception of quality of life and overall satisfaction with own health during the last two weeks on a 5-point Likert-scale ranging from very poor/very dissatisfied to very good/very satisfied. Two weeks (test-retest)
Secondary Resilience Adolescent elite athletes and controls will answer the self-reported questionnaire "The Resilience Scale for Adolescents (READ)" measuring their ability to handle stress and negative life events. The participants are asked to indicate how much they agree or disagree to 28 items using a 5-point Likert scale. Baseline
Secondary Resilience Adolescent elite athletes and controls will answer the self-reported questionnaire "The Resilience Scale for Adolescents (READ)" measuring their ability to handle stress and negative life events. The participants are asked to indicate how much they agree or disagree to 28 items using a 5-point Likert scale. 1 year after baseline
Secondary Resilience Adolescent elite athletes and controls will answer the self-reported questionnaire "The Resilience Scale for Adolescents (READ)" measuring their ability to handle stress and negative life events. The participants are asked to indicate how much they agree or disagree to 28 items using a 5-point Likert scale. Two weeks (test-retest)
Secondary Self-esteem Adolescent elite athletes and controls will answer the self-reported questionnaire "Rosenberg self-esteem scale" (RSES) consisting of 10 items measuring global self-esteem related to overall feelings of self-worth and self-acceptance. The participants are asked to indicate how much they agree or disagree to the items using a 4-point Likert scale ranging from strongly agree to strongly disagree. Baseline
Secondary Self-esteem Adolescent elite athletes and controls will answer the self-reported questionnaire "Rosenberg self-esteem scale" (RSES) consisting of 10 items measuring global self-esteem related to overall feelings of self-worth and self-acceptance. The participants are asked to indicate how much they agree or disagree to the items using a 4-point Likert scale ranging from strongly agree to strongly disagree. 1 year after baseline
Secondary Self-esteem Adolescent elite athletes and controls will answer the self-reported questionnaire "Rosenberg self-esteem scale" (RSES) consisting of 10 items measuring global self-esteem related to overall feelings of self-worth and self-acceptance. The participants are asked to indicate how much they agree or disagree to the items using a 4-point Likert scale ranging from strongly agree to strongly disagree. Two weeks (test-retest)
Secondary Subjective health complaints Adolescent elite athletes and controls will answer the self-reported questionnaire "Health Behavior in School Children" measuring how often they have experienced 8 different physical and psychological health complaints (on a five-point scale ranging from almost every day to seldom/never) during the last 6 months. Baseline
Secondary Subjective health complaints Adolescent elite athletes and controls will answer the self-reported questionnaire "Health Behavior in School Children" measuring how often they have experienced 8 different physical and psychological health complaints (on a five-point scale ranging from almost every day to seldom/never) during the last 6 months. 1 year after baseline
Secondary Subjective health complaints Adolescent elite athletes and controls will answer the self-reported questionnaire "Health Behavior in School Children" measuring how often they have experienced 8 different physical and psychological health complaints (on a five-point scale ranging from almost every day to seldom/never) during the last 6 months. Two weeks (test-retest)
Secondary Sexual harassment experiences from trainers Trainers and leaders will answer a questionnaire regarding their experiences with incidents of sexual harassment, awareness of reporting mechanisms and emergency plans, suggestions for how to prevent sexual harassment. Baseline
Secondary Sexual harassment interview In-depth interviews with students, trainers and leaders about their experiences with sexual harassment, awareness of reporting mechanisms and suggestions for how to prevent sexual harassment in the future. Baseline
Secondary Eating disorder examination (EDE) interview Students scoring above cut-off on the questionnaire EDE-q at the 1-year follow up questionnaire will be invited to a diagnostic interview (EDE) measuring eating disorder psychopathology/diagnosis. Following the 1 year-follow up questionnaire
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