- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05103371
A Prevention Program to Encourage Self-care, Self-esteem and Body-esteem Among Young Adolescents
Examining the Feasibility and Effectiveness of a Prevention Program for Encouraging Self-care, Self-esteem, Body-esteem and Media Literacy Among Young Adolescents
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Moria Golan
- Telefonnummer: 0547240330
- E-mail: moria.golan@mail.huji.ac.il
Studiesteder
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Upper Galilee
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Kiryat Shmona, Upper Galilee, Israel, 1220800
- Rekruttering
- Tel Hai College
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Kontakt:
- Moria Golan, Prof.
- E-mail: moria.golan@mail.huji.ac.il
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Kontakt:
- Dana Tzabari, M.Sc
- Telefonnummer: 0507744284
- E-mail: danatzabari91@gmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Parents of children 10-12 years old
- 10-12-year-old children of participating parents
- Participants who filled out the questionnaires before and after the program
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: "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.
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Prevention program: "Millie", with the participation of adolescents and parents
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Aktiv komparator: "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.
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Prevention program: "Millie", with the participation of adolescents only, no parental involvement in the program
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Ingen indgriben: 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
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change from Baseline in the Sociocultural Attitudes towards Appearance Questionnaire-4, Affects by Media subscale.
Tidsramme: 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
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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.
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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
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Change from Baseline in Rosenberg Self Esteem Scale
Tidsramme: 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
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Rosenberg Self Esteem Scale (Rosenberg, 1965)- 10 items.
Scoring involves a method of combined ratings.
Low self-esteem responses are "disagree" or
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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
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Ændring fra Baseline i Body Esteem Scale
Tidsramme: Målt tre gange over seks måneder: ved baseline, umiddelbart efter programmets afslutning, og tre måneder efter programmets afslutning, måling af en ændring i scores
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Body Esteem Scale- Dette spørgeskema undersøger selvværd af krop og fysisk fremtoning og består af 3 underskalaer: udseende (10 elementer), vægt (8 elementer) og tilskrivning 187 til andre (5 elementer).
Elementer vurderes på en 5-trins skala: (1) aldrig, (2) sjældent, (3) nogle gange, (4) 188 ofte og (5) altid.
En højere score indikerer højere kropsværd (Mendelson, Mendelson, & White, 2001)
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Målt tre gange over seks måneder: ved baseline, umiddelbart efter programmets afslutning, og tre måneder efter programmets afslutning, måling af en ændring i scores
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Ændring fra baseline i annonceringsskala
Tidsramme: Målt tre gange over seks måneder: ved baseline, umiddelbart efter programmets afslutning, og tre måneder efter programmets afslutning, måling af en ændring i scores
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Annonceskalaen indeholder 1 punkt - Identifikation af strategier brugt af medier.
Dette spørgsmål afspejles som en beskyttende faktor.
Den indeholder 8 forskellige strategier, som deltagerne vælger imellem: et højere antal identificerede strategier indikerer bedre mediekendskab.
(Golan et al., 2013).
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Målt tre gange over seks måneder: ved baseline, umiddelbart efter programmets afslutning, og tre måneder efter programmets afslutning, måling af en ændring i scores
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Ændring fra Baseline i Selvomsorg
Tidsramme: Målt tre gange over seks måneder: ved baseline, umiddelbart efter programmets afslutning, og tre måneder efter programmets afslutning, måling af en ændring i scores
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Udviklet af prof. Moria Golan og vurderet i tidligere forskning.
Indeholder 14 elementer, som er vurderet på en 4-trins skala: (1) aldrig, (2) sjældent, (3) nogle gange, (4) altid.
Elementer summeres, og højere score indikerer højere egenomsorgsadfærd.
Dette spørgeskema er designet til at vurdere egenomsorgsadfærd hos unge.
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Målt tre gange over seks måneder: ved baseline, umiddelbart efter programmets afslutning, og tre måneder efter programmets afslutning, måling af en ændring i scores
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Tel Hai-Academic
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