Primary PreventionNCT05102526
Increasing the Impact of a School Prevention Program Among Young Adolescents by Adding a Teacher Component
A study testing Experimental: "Young Millie" prevention program, active teachers and Prevention program: "Young Mili", non active teachers in people with Primary Prevention, run by Tel Hai College at 1 site in Israel.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 10 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Prevention
- What is being tested?
- Experimental: "Young Millie" prevention program, active teachers and Prevention program: "Young Mili", non active teachers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2021to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants who didn't complete the questionnaires at baseline or at least twice.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
Early adolescence (10-13 years) is characterized by hormonal changes and accelerated physiological growth. Significant risk factors for the physical and mental health of children and adolescents include, among other things, reduced physical activity, low self-esteem and self-esteem.
"Mili - a unique shield for daily resilience" is a preventive intervention program. The main goal of the program is to increase the self-care behaviors and self esteem of adolescents and prevent negative physical self-image, as well as to develop media literacy. In this study, researchers will focus on a school-based program designed for ages 10-12, grades 5-6, with a primary goal to develop self-care, media literacy, self-esteem, and positive body image. To increase the impact of the "Young Mili" program on adolescents, the researchers developed a teacher component as an adjunct to the school-based intervention, usually facilitated only by college students. The study will first evaluate the impact of teachers on the program, and then evaluate the difference between adolescent outcomes from the program with or without this supplement.
The results will be measured using the research questionnaire, to be completed by the participants (both teachers and adolescents) before, after, and three months after the end of the program. The questionnaire will include validated scales with good psychometric properties. In addition, qualitative interviews will be conducted among teachers. The study protocol was approved by the Tel Hai College Institutional Audit Committee. Parents of all participants, in the intervention and the control group, as well as teachers involved in the program, were given information about the program and the research and were asked to provide informed consent.
- Conditions
- Primary Prevention
- Being tested
- Experimental: "Young Millie" prevention program, active teachers, Prevention program: "Young Mili", non active teachers
- Keywords
- prevention-program, Physical assessment, self-esteem, self-care, Teachers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: "Young Millie" prevention program, active teachersBehavioural
Prevention program: "Young Mili", in collaboration with the teacher
Prevention program: "Young Mili", non active teachersBehavioural
Prevention program: "Young Mili", without the participation of the teacher
| Study group | Role | What they receive |
|---|---|---|
| "Young Millie" prevention program, active teachers | Experimental | The "Young Mili" program will be delivered to teens ages 10-12, over 3 months. The program contains nine 90-minute weekly sessions focusing on media literacy, self-esteem, self-esteem and physical self-esteem. Teachers will also participate by delivering planned activities to their students in addition to each week's theme, in parallel with an externally delivered program. All participants will complete a self-report questionnaire at the beginning of the study, after the end of the program and three months after the end of the program. Receives: Behavioral: Experimental: "Young Millie" prevention program, active teachers |
| "Young Mili" prevention program, passive teachers | Active comparator | The "Young Mili" program will be delivered to teens ages 10-12, over 3 months. The program contains nine 90-minute weekly sessions focusing on media literacy, self-esteem, self-esteem and body image. Teachers will not participate in the program, they will be present in class only during the program on transfer abroad. All participants will complete a self-report questionnaire at the beginning of the study, after the end of the program and three months after the end of the program. Receives: Behavioral: Prevention program: "Young Mili", non active teachers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
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: 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
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: 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
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: 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
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: 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 outcomes (1)
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: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Hai College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102526
- Sponsor's protocol ID
- Tel-Hai
- Status last verified
- Oct 2021
- First submitted
- 23 Oct 2021
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05102526
- Acronym / sponsor ID
- Tel-Hai
- Conditions
- Primary Prevention
- Keywords
- prevention-program, Physical assessment, self-esteem, self-care, Teachers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel Hai CollegeUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Early adolescence (10-13 years) is characterized by hormonal changes and accelerated physiological growth. Significant risk factors for the physical and mental health of children and adolescents include, among other things, reduced physical activity, low self-esteem and self-esteem.
"Mili - a unique shield for daily resilience" is a preventive intervention program. The main goal of the program is to increase the self-care behaviors and self esteem of adolescents and prevent negative physical self-image, as well as to develop media literacy. In this study, researchers will focus on a school-based program designed for ages 10-12, grades 5-6, with a primary goal to develop self-care, media literacy, self-esteem, and positive body image. To increase the impact of the "Young Mili" program on adolescents, the researchers developed a teacher component as an adjunct to the school-based intervention, usually facilitated only by college students. The study will first evaluate the impact of teachers on the program, and then evaluate the difference between adolescent outcomes from the program with or without this supplement.
The results will be measured using the research questionnaire, to be completed by the participants (both teachers and adolescents) before, after, and three months after the end of the program. The questionnaire will include validated scales with good psychometric properties. In addition, qualitative interviews will be conducted among teachers. The study protocol was approved by the Tel Hai College Institutional Audit Committee. Parents of all participants, in the intervention and the control group, as well as teachers involved in the program, were given information about the program and the research and were asked to provide informed consent.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Young Millie" prevention program, active teachers | Experimental | Behavioral: Experimental: "Young Millie" prevention program, active teachersThe "Young Mili" program will be delivered to teens ages 10-12, over 3 months. The program contains nine 90-minute weekly sessions focusing on media literacy, self-esteem, self-esteem and physical self-esteem. Teachers will also participate by delivering planned activities to their students in addition to each week's theme, in parallel with an externally delivered program. All participants will complete a self-report questionnaire at the beginning of the study, after the end of the program and three months after the end of the program. |
| "Young Mili" prevention program, passive teachers | Active comparator | Behavioral: Prevention program: "Young Mili", non active teachersThe "Young Mili" program will be delivered to teens ages 10-12, over 3 months. The program contains nine 90-minute weekly sessions focusing on media literacy, self-esteem, self-esteem and body image. Teachers will not participate in the program, they will be present in class only during the program on transfer abroad. All participants will complete a self-report questionnaire at the beginning of the study, after the end of the program and three months after the end of the program. |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants who didn't complete the questionnaires at baseline or at least twice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: "Young Millie" prevention program, active teachersPrevention program: "Young Mili", in collaboration with the teacher | Behavioural | "Young Millie" prevention program, active teachers |
| Prevention program: "Young Mili", non active teachersPrevention program: "Young Mili", without the participation of the teacher | Behavioural | "Young Mili" prevention program, passive teachers |
Primary outcome
Change from Baseline in the Sociocultural Attitudes towards Appearance Questionnaire-4, Affects by Media subscale.
Time frame: 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
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.
Change from Baseline in Rosenberg Self Esteem Scale
Time frame: 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
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.
Change from Baseline in Body Esteem Scale
Time frame: 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
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)
Change from Baseline in Advertising Scale
Time frame: 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
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).
Change from Baseline in Self-Care behaviors
Time frame: 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
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.
1 secondary outcome
Change from Baseline in The Connor-Davidson Resilience Scale (CD-RISC)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Primary Prevention
Recruiting
Food Supplement for Individuals With Polygenic Hypercholesterolaemia
Polygenic Hypercholesterolaemia
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: "Young Millie" prevention program, active teachers and Prevention program: "Young Mili", non active teachers in people with Primary Prevention, run by Tel Hai College at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Sociocultural Attitudes towards Appearance Questionnaire-4, Affects by Media subscale. (time frame: 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.