Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05103371
Other study ID # Tel Hai-Academic
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date December 1, 2023

Study information

Verified date October 2021
Source Tel Hai College
Contact Moria Golan
Phone 0547240330
Email moria.golan@mail.huji.ac.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Early adolescence (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 others, harmful physical activity, self-esteem and low self-esteem, and negative body image. "Milli - a special shield for daily resilience" is a preventive intervention program. The main goal of the program is to raise adolescents' self-confidence and prevent negative self-image and body image as well as develop media literacy. In this study, the researchers will focus on the "Young Millie" program, designed for ages 10-12, fifth and sixth grades, and its core is the development of self-care. To increase the impact of the program on adolescents, the researchers developed a program that will be delivered to parents via a their adolescent children, as the 'agents of change'. Adloescents in the parent-component group will be given assignments to complete together with their parents at home, in coherence with the subject discussed in the weekly session of the school-based program. The study will first evaluate the influence of parents 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 adolescents before, after, and three months after the completion of the program. The questionnaire will include validated questionnaires with good psychometric qualities. Parents will fill out a satisfaction questionnaire before and after 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 1, 2023
Est. primary completion date March 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Experiment: "Millie" prevention program, adolescents and active parents
Prevention program: "Millie", with the participation of adolescents and parents
Experiment: "Millie" prevention program, adolescents only
Prevention program: "Millie", with the participation of adolescents only, no parental involvement in the program

Locations

Country Name City State
Israel Tel Hai College Kiryat Shmona Upper Galilee

Sponsors (1)

Lead Sponsor Collaborator
Tel Hai College

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT04156061 - Effect of the SCOT-HEART 2 Trial on Lifestyle. N/A
Completed NCT00145782 - The Ebeltoft Health Promotion Project Phase 3
Terminated NCT04243278 - Postpartum Low-Dose Aspirin After Preeclampsia for Optimization of Cardiovascular Risk (PAPVASC) Early Phase 1
Completed NCT03234322 - The Impact of a Diabetes Risk Prediction Model in Primary Care. N/A
Enrolling by invitation NCT04682613 - Increasing the Effect of a School-based Prevention Program by Teacher Involvement N/A
Enrolling by invitation NCT04688619 - Adolescents as Change Agents in the Incorporation of a Parental Component for a School Based Prevention Program N/A
Completed NCT04162626 - New Families- Innovation and Development of the Child Health Services in Oslo N/A
Completed NCT03316911 - A Pilot Study Testing a Life Skills Application to Address Interpersonal Relationships in College N/A
Completed NCT03715426 - Testing a Life Skills Application to Address Interpersonal Relationships in College (MKit) N/A
Completed NCT04114864 - A Primary Prevention Intervention for the Promotion of Psycho-social Wellbeing in Adolescent Young Carers: Phase 1/Phase 2
Active, not recruiting NCT02984553 - Objective Physical Activity Assesment in Postmenopausal Women N/A
Terminated NCT03590730 - Benefits of ICD for the Primary Prevention in Patients With Valvular Cardiomyopathy
Enrolling by invitation NCT05102526 - Increasing the Impact of a School Prevention Program Among Young Adolescents by Adding a Teacher Component N/A
Completed NCT03540277 - Prevention Program- Promoting Self Resilience, Positive Self-Image and Body Image Among Adolescents and Their Parents N/A
Recruiting NCT04279964 - Engaging Practices and Communities in the Development of Interventions to Promote HPV Vaccine Uptake N/A
Completed NCT02653586 - Prevention Program Promoting Self Resilience,Positive Self-Image and Body Image Among Adolescence Aged 15-17 N/A
Enrolling by invitation NCT03129165 - ProSALUTE: Community Program for Cardiovascular Health N/A
Recruiting NCT04065191 - Workplace HIIT: Feasibility and Preventive Effects of HIIT in the Real-World N/A
Completed NCT06127732 - Phytosterol Supplementation and Lipoprotein Subfractions N/A
Completed NCT00456911 - Family Dietary Coaching to Improve Nutritional Intakes and Body Weight Control N/A