Clinical trial NCT05102526: Increasing the Impact of a School Prevention Program Among Young Adolescents by Adding a Teacher Component
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Prevention
Keywords: prevention-program
Physical assessment
self-esteem
self-care
Teachers
Lead sponsor: Tel Hai College
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in the Sociocultural Attitudes towards Appearance Questionnaire-4, Affects by Media subscale.
timeFrame: 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
measure: Change from Baseline in Rosenberg Self Esteem Scale
timeFrame: 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
measure: Change from Baseline in Body Esteem Scale
timeFrame: 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
measure: Change from Baseline in Advertising Scale
timeFrame: 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
measure: Change from Baseline in Self-Care behaviors
timeFrame: 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:
measure: Change from Baseline in The Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: 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
Other outcomes:
Locations:
city: Kiryat Shmona
country: Israel
facility: Tel Hai College
state: Upper Galilee
Study officials:
References: