NCT05102526

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

1.1 years

First QC Date

October 23, 2021

Last Update Submit

October 23, 2021

Conditions

Keywords

prevention-programPhysical assessmentself-esteemself-careTeachers

Outcome Measures

Primary Outcomes (5)

  • 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, at program termination (immediately after last session), and three months after the completion of the program, measuring a change in scores

  • 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 "strongly disagree" on items 1, 3, 4, 7, 10, and "strongly agree" or "agree" on items 2, 5, 6, 8, 9. Two or three out of three correct responses to items 3, 7, and 9 are scored as one item. One or two out of two correct responses for items 4 and 5 are considered as a single item; items 1,8, and 10 are scored as individual items; and combined correct responses (one or two out of two) to items 2 and 6 are considered to be a single item.

    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

  • 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, at program termination (immediately after last session), and three months after the completion of the program, measuring a change in scores

  • 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, at program termination (immediately after last session), and three months after the completion of the program, measuring a change in scores

  • Change from Baseline in Self-Care behaviors

    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, at program termination (immediately after last session), and three months after the completion of the program, measuring a change in scores

Secondary Outcomes (1)

  • Change from Baseline in The Connor-Davidson Resilience Scale (CD-RISC)

    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

Study Arms (2)

"Young Millie" prevention program, active teachers

EXPERIMENTAL

The "Young Mili" program will be delivered to teens ages 10-12, over 3 months. The program contains nine 90-minute weekly sessions focusing on media literacy, self-esteem, self-esteem and physical self-esteem. Teachers will also participate by delivering planned activities to their students in addition to each week's theme, in parallel with an externally delivered program. All participants will complete a self-report questionnaire at the beginning of the study, after the end of the program and three months after the end of the program.

Behavioral: Experimental: "Young Millie" prevention program, active teachers

"Young Mili" prevention program, passive teachers

ACTIVE COMPARATOR

The "Young Mili" program will be delivered to teens ages 10-12, over 3 months. The program contains nine 90-minute weekly sessions focusing on media literacy, self-esteem, self-esteem and body image. Teachers will not participate in the program, they will be present in class only during the program on transfer abroad. All participants will complete a self-report questionnaire at the beginning of the study, after the end of the program and three months after the end of the program.

Behavioral: Prevention program: "Young Mili", non active teachers

Interventions

Prevention program: "Young Mili", in collaboration with the teacher

"Young Millie" prevention program, active teachers

Prevention program: "Young Mili", without the participation of the teacher

"Young Mili" prevention program, passive teachers

Eligibility Criteria

Age10 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Teachers of elementary school classes
  • 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.

You may not qualify if:

  • Participants who didn't complete the questionnaires at baseline or at least twice.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Hai College

Kiryat Shmona, Upper Galilee, 1220800, Israel

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2021

First Posted

November 1, 2021

Study Start

November 1, 2021

Primary Completion

December 1, 2022

Study Completion

October 1, 2023

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations