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

NCT ID: NCT05103371

Last Updated: 2021-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-12-01

Brief Summary

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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

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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.

Conditions

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Primary Prevention

Keywords

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prevention program body-image self-esteem parents adolescents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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"Mili" prevention program, adolescents and active parents

The program "Mili" will be delivered to adolescence aged 10-12, over 3 months. The program contains nine weekly, 90-min sessions that focus on Media literacy, self-esteem, self-image and body image. The parents will also participate by a phone app that will pass the parents activities to do with their children, in parallel to the program. All participants will complete a self-report questionnaire at baseline, after the program ends, and three months after the completion of the program.

Group Type EXPERIMENTAL

Experiment: "Millie" prevention program, adolescents and active parents

Intervention Type BEHAVIORAL

Prevention program: "Millie", with the participation of adolescents and parents

"Mili" prevention program, adolescents only

The program "Mili" will be delivered to adolescence aged 10-12, over 3 months. The program contains nine weekly, 90-min sessions that focus on Media literacy, self-esteem, self-image and body image, no parental involvement in the program. Adolescents will complete a self-report questionnaire at baseline, after the program ends, and three months after the completion of the program.

Group Type ACTIVE_COMPARATOR

Experiment: "Millie" prevention program, adolescents only

Intervention Type BEHAVIORAL

Prevention program: "Millie", with the participation of adolescents only, no parental involvement in the program

control group

The control group will not receive the intervention program. The control group will complete the same self-report questionnaire as the intervention group at baseline, after the program ends, and three months after the completion of the program

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Experiment: "Millie" prevention program, adolescents and active parents

Prevention program: "Millie", with the participation of adolescents and parents

Intervention Type BEHAVIORAL

Experiment: "Millie" prevention program, adolescents only

Prevention program: "Millie", with the participation of adolescents only, no parental involvement in the program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tel Hai College

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tel Hai College

Kiryat Shmona, Upper Galilee, Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Moria Golan

Role: CONTACT

Phone: 0547240330

Email: [email protected]

Facility Contacts

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Moria Golan, Prof.

Role: primary

Dana Tzabari, M.Sc

Role: backup

Other Identifiers

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Tel Hai-Academic

Identifier Type: -

Identifier Source: org_study_id