Clinical trial NCT03540277: Prevention Program- Promoting Self Resilience, Positive Self-Image and Body Image Among Adolescents and Their Parents
Official title: The Effect of Addition of Parental Component to the Program "Young In Favor of Myself" on Participating Parents and Their Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Prevention
Keywords: prevention program
body-image
self-esteem
parents
adolescents
Lead sponsor: Tel Hai College
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 420
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 program that will be passed on to parents through a telephone application. 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 participants (both parents and adolescents) 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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: Change from Baseline in the Sociocultural Attitudes towards Appearance Questionnaire-4, Affects by Media subscale.
timeFrame: Measured three times over six months: at baseline, after the program ends, and three months after the completion of the program, measuring a change in scores
measure: Change from Baseline in Rosenberg Self Esteem Scale
timeFrame: Measured three times over six months: at baseline, after the program ends, and three months after the completion of the program, measuring a change in scores
measure: Change from Baseline in Body Esteem Scale
timeFrame: Measured three times over six months: at baseline, after the program ends, and three months after the completion of the program, measuring a change in scores
measure: Change from Baseline in Eating Disorder Examination- Questionnaire (EDE-Q8)
timeFrame: Measured three times over six months: at baseline, after the program ends, and three months after the completion of the program, measuring a change in scores
measure: Change from Baseline in Advertising Scale
timeFrame: Measured three times over six months: at baseline, after the program ends, and three months after the completion of the program, measuring a change in scores
measure: Change from Baseline in Self-Caring
timeFrame: Measured three times over six months: at baseline, after the program ends, and three months after the completion of the program, measuring a change in scores
Secondary outcomes:
measure: The 11-item Knowledge Test BEC
timeFrame: Measured three times over six months: at baseline, after the program ends, and three months after the completion of the program, measuring a change in scores
Other outcomes:
Locations:
city: Kiryat Shmona
country: Israel
facility: Tel Hai Academic College
state: North Of Israel
Study officials:
affiliation: Tel Hai College
name: Moria Golan, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Golan M, Benifla S, Samo A, Alon N, Mozeikov M. Feasibility and effect of adding a concurrent parental component to a school-based wellness program using two modes of mobile-based technology - mixed methods evaluation of RCT. BMC Public Health. 2022 Feb 14;22(1):297. doi: 10.1186/s12889-022-12581-7.