Increasing the Impact of a School Prevention Program Among Young Adolescents by Adding a Teacher Component

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Primary Prevention
• Intervention / Treatment: Behavioral: Experimental: "Young Millie" prevention program, active teachers; Behavioral: Prevention program: "Young Mili", non active teachers

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Upper Galilee
    • Kiryat Shmona, Upper Galilee, Israel, 1220800
      • Tel Hai College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "Young Millie" prevention program, active teachers; 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.	Behavioral: Experimental: "Young Millie" prevention program, active teachers; Prevention program: "Young Mili", in collaboration with the teacher
Active Comparator: "Young Mili" prevention program, passive teachers; 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.	Behavioral: Prevention program: "Young Mili", non active teachers; Prevention program: "Young Mili", without the participation of the teacher

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tel Hai College

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: October 23, 2021
• First Submitted That Met QC Criteria: October 23, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 23, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: self-esteem; self-care; prevention-program; Physical assessment; Teachers
• Other Study ID Numbers: Tel-Hai

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No