Adolescents as Change Agents in the Incorporation of a Parental Component for a School Based Prevention Program

NCT ID: NCT04688619

Last Updated: 2021-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-02-01

Brief Summary

Cluster-Randomized Clinical trial, which includes the development and activation of an intervention program among young adolescents and their parents. Adolescents will be the "change agents" and will receive activities and assignments to complete together with their parents, as a mean for increasing parental involvement in the program. 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, immediately 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

Early adolescent (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 other things, disordered eating patterns, overweight and reduced physical activity, low self-esteem and negative body image.

"In Favor of Myself" is a preventive intervention program. The program's primary goal is to increase adolescents' self-esteem and to prevent negative self-image and body image, as well as to development media literacy. In this study, the investigators will focus on the "Young In Favor of Myself " program, designed for ages 10-12, grades 5 and 6, and its main core is the development of self-care. To increase the effect of "Young In Favor of Myself " program on the adolescents, the investigators have developed a parental component in addition to the school-based activities. The adolescent participants will receive activities and assignments to complete together with their parents, making them the "change agents", with a goal of increasing parental involvement in the program. The study will first assess the parents' influence 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 adolescent participants before, immediately after, and three months after the completion of the program. The questionnaire will include validated questionnaires with good psychometric qualities. Parents will complete a satisfaction questionnaire at the end of 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

Primary Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

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 parents will also participate by receiving activities to do with their children, given to the adolescents during the scool 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

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

Intervention Type: BEHAVIORAL

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

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

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 parents won't participate in the program, they will get only a brochure about Media literacy, self-esteem, self-image and body image. 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: ACTIVE_COMPARATOR

Prevention Program "young In Favor of Myself", no parental involvement

Intervention Type: BEHAVIORAL

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

Interventions

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

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

Intervention Type: BEHAVIORAL

Prevention Program "young In Favor of Myself", no parental involvement

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

Tel Hai College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Academic College of Tel Hai

Kiryat Shmona, North of Israel, Israel

Countries

Israel

Other Identifiers

Tel-Hai Academic College

Identifier Type: -

Identifier Source: org_study_id