Primary Prevention Clinical Trial
Official title:
The Impact of a School-based Program on the Psychological Health of Young Adolescents: The Facilitator Role of a Teacher Component and Content Delivered in the School
Verified date | October 2021 |
Source | Tel Hai College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A randomized clinical trial in clusters, including the development and implementation of an intervention program among young adolescents and their teachers. The research hypothesis is that the intervention program will yield improvement in adolescents whose parents participated in the program, compared with adolescents whose teachers were not involved in the intervention. The results will be measured using the research questionnaire, which participants will complete before, after and three months after the end of the program. The questionnaire will include approved questionnaires with good psychometric properties. In addition, there will be a quality interview. The study protocol was approved by the Tel Hai College Institutional Audit Committee. Parents of all participants in the intervention and control group as well as the teachers involved in the program received information about the program and research and were asked to give informed consent.
Status | Enrolling by invitation |
Enrollment | 100 |
Est. completion date | October 1, 2023 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 10 Years to 70 Years |
Eligibility | Inclusion Criteria: - Teachers of elementary school classes - 10-12-year-old students of participating teachers - Participants who filled out the questionnaires before and after the program - Participants whose parents signed a letter of informed consent. Exclusion Criteria: - Participants who didn't complete the questionnaires at baseline or at least twice. |
Country | Name | City | State |
---|---|---|---|
Israel | Tel Hai College | Kiryat Shmona | Upper Galilee |
Lead Sponsor | Collaborator |
---|---|
Tel Hai College |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in the Sociocultural Attitudes towards Appearance Questionnaire-4, Affects by Media subscale. | The Sociocultural Attitudes Towards Appearance Questionnaire (Schaefer et al., 2015). The investigators included the Media subscale, including 4 items. Items are rated on a 5-point scale: (1) always, (2) often, (3) sometimes, (4) rarely, (5) never. The total score is based on computing the average. A higher score indicates higher pressure from the media to change one's look. | Measured three times over six months: at baseline, at program termination (immediately after last session), and three months after the completion of the program, measuring a change in scores | |
Primary | Change from Baseline in Rosenberg Self Esteem Scale | Rosenberg Self Esteem Scale (Rosenberg, 1965)- 10 items. Scoring involves a method of combined ratings. Low self-esteem responses are "disagree" or "strongly disagree" on items 1, 3, 4, 7, 10, and "strongly agree" or "agree" on items 2, 5, 6, 8, 9. Two or three out of three correct responses to items 3, 7, and 9 are scored as one item. One or two out of two correct responses for items 4 and 5 are considered as a single item; items 1,8, and 10 are scored as individual items; and combined correct responses (one or two out of two) to items 2 and 6 are considered to be a single item. | Measured three times over six months: at baseline, at program termination (immediately after last session), and three months after the completion of the program, measuring a change in scores | |
Primary | Change from Baseline in Body Esteem Scale | Body Esteem Scale- This questionnaire examines self-esteem of body and physical appearance and consists of 3 subscales: appearance (10 items), weight (8 items) and attribution 187 to others (5 items). Items are rated on a 5-point scale: (1) never, (2) rarely, (3) sometimes, (4) 188 often, and (5) always. A higher score indicates higher body-esteem (Mendelson, Mendelson, & White, 2001) | Measured three times over six months: at baseline, at program termination (immediately after last session), and three months after the completion of the program, measuring a change in scores | |
Primary | Change from Baseline in Advertising Scale | The Advertising scale contains 1 item- Identification of strategies used by media. This question is reflected as a protective factor. It contains 8 different strategies which participants choose from: higher number of strategies identified indicate better media literacy. (Golan et al., 2013). | Measured three times over six months: at baseline, at program termination (immediately after last session), and three months after the completion of the program, measuring a change in scores | |
Primary | Change from Baseline in Self-Care behaviors | Developed by Prof. Moria Golan and assessed in previous research. Includes 14 items which are rated on a 4-point scale: (1) never, (2) rarely, (3) sometimes, (4) always. Items are summed, and higher scores indicate higher self-care behaviors. This questionnaire was designed to assess self care behaviors in adolescents. | Measured three times over six months: at baseline, at program termination (immediately after last session), and three months after the completion of the program, measuring a change in scores | |
Secondary | Change from Baseline in The Connor-Davidson Resilience Scale (CD-RISC) | The CD-RISC is based on Connor and Davidson's operational definition of resilience, which is the ability to "thrive in the face of adversity." The scale includes 25 items, from 5 sub-scales: | Measured three times over six months: at baseline, at program termination (immediately after last session), and three months after the completion of the course, measuring a change in scores |
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