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

NCT04688619 | Unknown DMC

• 1 other identifier: Tel-Hai Academic College
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Prevention

Outcome Measures

Primary Outcomes (6)

• Change from Baseline in the Sociocultural Attitudes towards Appearance Questionnaire-4, Affects by Media subscale.

  he 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 "strongly disagree" on items 1, 3, 4, 7, 10, and "strongly agree" or "agree" on items 2, 5, 6, 8, 9. Two or three out of three correct responses to items 3, 7, and 9 are scored as one item. One or two out of two correct responses for items 4 and 5 are considered as a single item; items 1,8, and 10 are scored as individual items; and combined correct responses (one or two out of two) to items 2 and 6 are considered to be a single item.

  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 Eating Disorder Examination- Questionnaire (EDE-Q8)

  Eating Disorder Examination- Questionnaire short version (EDE-Q8). The items are rated on a 6-point scale: (1) never, (2) rarely, (3) sometimes, (4) often, (5) usually, and (6) always. EDE-Q provides assessment of eating disorder psychopathology related to anorexia nervosa (AN), bulimia nervosa (BN), and binge-eating disorder (BED). (Kliem et al, 2016)

  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 (2)

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

EXPERIMENTAL

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.

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

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

ACTIVE COMPARATOR

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.

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

Interventions

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

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

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

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

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

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

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (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.

Sponsors & Collaborators

• Tel Hai College: lead

Study Sites (1)

Academic College of Tel Hai

Kiryat Shmona, North of Israel, 1220800, Israel

Location

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: December 23, 2020
• First Posted: December 30, 2020
• Study Start: September 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: October 6, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)