Clinical trial NCT05103371: A Prevention Program to Encourage Self-care, Self-esteem and Body-esteem Among Young Adolescents
Official title: Examining the Feasibility and Effectiveness of a Prevention Program for Encouraging Self-care, Self-esteem, Body-esteem and Media Literacy Among Young Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Prevention
Keywords: prevention program
body-image
self-esteem
parents
adolescents
Lead sponsor: Tel Hai College
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 150
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cluster-Randomized Clinical trial, which includes the development and activation of an intervention program among young adolescents and their parents. Study hypothesis is that the intervention program will yield improvement in adolescents whose parents participated in the program, in comparison with the adolescents whose parents weren't involved in the intervention. Results will be measured using the study questionnaire, to be filled out by the participants before, after, and three months after the completion of the program. The questionnaire will include validated questionnaires with good psychometric qualities. The study protocol was approved by Tel Hai College institutional review board. Parents of all participants, in the intervention and in the control group, received information about the program and the study and were asked to provide 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 others, harmful physical activity, self-esteem and low self-esteem, and negative body image.

"Milli - a special shield for daily resilience" is a preventive intervention program. The main goal of the program is to raise adolescents' self-confidence and prevent negative self-image and body image as well as develop media literacy. In this study, the researchers will focus on the "Young Millie" program, designed for ages 10-12, fifth and sixth grades, and its core is the development of self-care. To increase the impact of the program on adolescents, the researchers developed a program that will be delivered to parents via a their adolescent children, as the 'agents of change'. Adloescents in the parent-component group will be given assignments to complete together with their parents at home, in coherence with the subject discussed in the weekly session of the school-based program.

The study will first evaluate the influence of parents on the program, and then evaluate the difference in adolescent outcomes from the program with or without this supplement.

Results will be measured using the study questionnaire, to be filled out by the adolescents before, after, and three months after the completion of the program. The questionnaire will include validated questionnaires with good psychometric qualities. Parents will fill out a satisfaction questionnaire before and after the program. The study protocol was approved by Tel Hai College institutional review board. Parents of all participants, in the intervention and in the control group, received information about the program and the study and were asked to provide informed consent.

Eligibility criteria: Inclusion Criteria:

1. Parents of children 10-12 years old
2. 10-12-year-old children of participating parents
3. Participants who filled out the questionnaires before and after the program
4. Participants whose parents signed a letter of informed consent.

Exclusion Criteria:

1. 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, immediately after the program ends, 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, immediately after the program ends, 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, immediately after the program ends, 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, immediately after the program ends, and three months after the completion of the program, measuring a change in scores
measure: Change from Baseline in Self-Caring
timeFrame: Measured three times over six months: at baseline, immediately after the program ends, and three months after the completion of the program, measuring a change in scores
Secondary outcomes:
Other outcomes:
Locations:
city: Kiryat Shmona
country: Israel
facility: Tel Hai College
state: Upper Galilee
Study officials:
References: