NCT05103371

Brief 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.

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
150

participants targeted

Target at 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

October 21, 2021

Last Update Submit

October 21, 2021

Conditions

Keywords

prevention programbody-imageself-esteemparentsadolescents

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, immediately after the program ends, 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

    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

  • 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

  • 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

  • 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

Study Arms (3)

"Mili" prevention program, adolescents and active parents

EXPERIMENTAL

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.

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

"Mili" prevention program, adolescents only

ACTIVE COMPARATOR

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.

Behavioral: Experiment: "Millie" prevention program, adolescents only

control group

NO INTERVENTION

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

Interventions

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

"Mili" prevention program, adolescents and active parents

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

"Mili" prevention program, adolescents only

Eligibility Criteria

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

You may qualify if:

  • Parents of children 10-12 years old
  • 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.

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

RECRUITING

Central Study Contacts

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 21, 2021

First Posted

November 2, 2021

Study Start

November 1, 2021

Primary Completion

March 1, 2022

Study Completion

December 1, 2023

Last Updated

November 2, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations