NCT04682613

Brief Summary

Cluster-Randomized Clinical trial, which includes the development and activation of an intervention program among young adolescents and their teachers. Study hypothesis is that the intervention program will yield improvement in adolescents whose teachers participated in the program, in comparison with the adolescents whose teachers 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 student participants in the intervention and in the control group, as well as teachers involved in the program, received information about the program and the study and were asked to provide 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 Sep 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

1.7 years

First QC Date

December 15, 2020

Last Update Submit

August 19, 2021

Conditions

Keywords

prevention-programbody-imageself-esteemself-care

Outcome Measures

Primary Outcomes (6)

  • 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. The scale will only be used in the child questionnaire, not in the teacher version.

    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. The scale will only be used in the child questionnaire, not in the teacher version.

    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) The scale will be used in both the child and teacher questionnaire versions.

    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 Child- Eating Disorder Examination- Questionnaire (Ch-EDE-Q8)

    Child Eating Disorder Examination- Questionnaire short version (EDE-Q8). The items are rated on a 6-point scale: (1) never, (2) rarely, (3) sometimes, (4) often, (5) usually, and (6) always. EDE-Q provides assessment of eating disorder psychopathology related to anorexia nervosa (AN), bulimia nervosa (BN), and binge-eating disorder (BED). (Kliem et al, 2016) The scale will only be used in the child questionnaire, not in the teacher version.

    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). The scale will only be used in the child questionnaire, not in the teacher version.

    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. The scale will only be used in the child questionnaire, not in the teacher version.

    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)

Prevention Program "young In Favor of Myself", active teachers

EXPERIMENTAL

The program "young In Favor of Myself" 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 teachers will also participate by delivering planned activities to do with their pupils in addition to each week's topic, parallel to the externally-delivered program. All participants will complete a self-report questionnaire at baseline, after the program ends, and three months after the completion of the program.

Behavioral: Experimental: Prevention Program "young In Favor of Myself", active teachers

Prevention Program "young In Favor of Myself", passive teachers

ACTIVE COMPARATOR

The program "young In Favor of Myself" 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 teachers won't participate in the program, they will only be present in the classroom during the externally-delivered program. All participants will complete a self-report questionnaire at baseline, after the program ends, and three months after the completion of the program.

Behavioral: Experimental: Prevention Program "young In Favor of Myself", no teacher involvement

Interventions

Prevention program: "young In Favor of Myself", with teacher participation

Prevention Program "young In Favor of Myself", active teachers

Prevention program: "young In Favor of Myself", without teacher participation

Prevention Program "young In Favor of Myself", 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 10-12-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 Officials

  • Moria Golan, Prof.

    Tel Hai College

    PRINCIPAL INVESTIGATOR

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

December 15, 2020

First Posted

December 24, 2020

Study Start

September 1, 2020

Primary Completion

June 1, 2022

Study Completion

October 1, 2022

Last Updated

August 20, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations