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

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05102526
• Other study ID #: Tel-Hai
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2021
• Source: Tel Hai College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Primary Prevention

Intervention

Behavioral:
• Experimental: "Young Millie" prevention program, active teachers
Prevention program: "Young Mili", in collaboration with the teacher
• Prevention program: "Young Mili", non active teachers
Prevention program: "Young Mili", without the participation of the teacher

Locations

Country	Name	City	State
Israel	Tel Hai College	Kiryat Shmona	Upper Galilee

Sponsors (1)

Lead Sponsor	Collaborator
Tel Hai College

Country where clinical trial is conducted

Israel, 

Outcome

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