Clinical trial NCT04688619: Adolescents as Change Agents in the Incorporation of a Parental Component for a School Based Prevention Program
Official title: Adolescents as Change Agents in the Incorporation of a Parental Component for a School Based Prevention Program, to Promote Self-care Behaviors, Self Esteem, and Media Literacy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Prevention
Lead sponsor: Tel Hai College
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 150
Sex: ALL
Minimum age (years): 10
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. 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.

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.

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, immediately 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, immediately 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, immediately 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, immediately 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, immediately 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, immediately after the program ends, and three months after the completion of the program, measuring a change in scores
Secondary outcomes:
Other outcomes:
Locations:
city: Kiryat Shmona
country: Israel
facility: Academic College of Tel Hai
state: North Of Israel
Study officials:
References: