A Prevention Program to Encourage Self-care, Self-esteem and Body-esteem Among Young Adolescents

Primary Prevention Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05103371
• Other study ID #: Tel Hai-Academic
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: October 2021
• Source: Tel Hai College
• Contact: Moria Golan
• Phone: 0547240330
• Email: moria.golan[@]mail.huji.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 1, 2023
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Primary Prevention

Intervention

Behavioral:
• Experiment: "Millie" prevention program, adolescents and active parents
Prevention program: "Millie", with the participation of adolescents and parents
• Experiment: "Millie" prevention program, adolescents only
Prevention program: "Millie", with the participation of adolescents only, no parental involvement in the program

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, immediately after the program ends, 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	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
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, immediately after the program ends, 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, immediately after the program ends, and three months after the completion of the program, measuring a change in scores
Primary	Change from Baseline in Self-Caring	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, immediately after the program ends, and three months after the completion of the program, measuring a change in scores