Efficacy Study of Amazing Me Program

NCT04754126 | Completed

• 1 other identifier: STUDY00012339
• Study Type: interventional
• Target: 421
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the Efficacy Study of Amazing Me Program is to deliver the Amazing Me intervention and assess its efficacy. The Amazing Me intervention aims to help children between the ages of 9 and 11 build self-esteem, body confidence, and eliminate weight-based bullying and teasing. The Amazing Me intervention teaches students to be kind to themselves, their bodies, and to others.

Conditions

Self Esteem; Body Distorted Images

Keywords

body satisfaction; self esteem; weight-based bullying and teasing

Outcome Measures

Primary Outcomes (9)

• Body-Esteem Scale

  The Body-Esteem Scale is a 24-item self-report measure designed for use with children. The items were developed to assess how children feel about themselves and how they believe others view them. Sample items include "I like what I look like in pictures" and "There are lots of things I'd change about my looks if I could." Children responded by selecting "yes" or "no" for each item. In this study, children were also given the option of selecting "I don't want to answer." This scale has been found to be a reliable measure of body esteem in children as young as 7 years old. All items from this scale were used in the pilot study.

  Baseline,

• Body-Esteem Scale

  The Body-Esteem Scale is a 24-item self-report measure designed for use with children. The items were developed to assess how children feel about themselves and how they believe others view them. Sample items include "I like what I look like in pictures" and "There are lots of things I'd change about my looks if I could." Children responded by selecting "yes" or "no" for each item. In this study, children were also given the option of selecting "I don't want to answer." This scale has been found to be a reliable measure of body esteem in children as young as 7 years old. All items from this scale were used in the pilot study.

  6 weeks after baseline

• Body-Esteem Scale

  The Body-Esteem Scale is a 24-item self-report measure designed for use with children. The items were developed to assess how children feel about themselves and how they believe others view them. Sample items include "I like what I look like in pictures" and "There are lots of things I'd change about my looks if I could." Children responded by selecting "yes" or "no" for each item. In this study, children were also given the option of selecting "I don't want to answer." This scale has been found to be a reliable measure of body esteem in children as young as 7 years old. All items from this scale were used in the pilot study.

  9-12 month follow up

• Physical Appearance Related Teasing Scale

  The Physical Appearance Related Teasing Scale was adapted for the current study. The original scale consists of 18 items with two factors: weight/size teasing and general appearance teasing. Items 1, 2, 3, 4, 5, 6, 14, 16, 17, 18 were used in the current study. Items 1-6 load onto the weight/size teasing factor and items 14, 16, 17-18 load onto the general appearance teasing factor. Items were modified to be developmentally appropriate. The Perception of Teasing Scale (POTS) was incorporated to measure perceptions of distress where participants were asked to rate the degree to which they were upset by the teasing on a 3-point Likert scale ranging from 1 (not upset) to 3 (very upset), modified from the original The POTS was originally developed with adults and has been used extensively with children and adolescents.

  Baseline

• Physical Appearance Related Teasing Scale

  The Physical Appearance Related Teasing Scale was adapted for the current study. The original scale consists of 18 items with two factors: weight/size teasing and general appearance teasing. Items 1, 2, 3, 4, 5, 6, 14, 16, 17, 18 were used in the current study. Items 1-6 load onto the weight/size teasing factor and items 14, 16, 17-18 load onto the general appearance teasing factor. Items were modified to be developmentally appropriate. The Perception of Teasing Scale (POTS) was incorporated to measure perceptions of distress where participants were asked to rate the degree to which they were upset by the teasing on a 3-point Likert scale ranging from 1 (not upset) to 3 (very upset), modified from the original The POTS was originally developed with adults and has been used extensively with children and adolescents.

  6 weeks after baseline

• Physical Appearance Related Teasing Scale

  The Physical Appearance Related Teasing Scale was adapted for the current study. The original scale consists of 18 items with two factors: weight/size teasing and general appearance teasing. Items 1, 2, 3, 4, 5, 6, 14, 16, 17, 18 were used in the current study. Items 1-6 load onto the weight/size teasing factor and items 14, 16, 17-18 load onto the general appearance teasing factor. Items were modified to be developmentally appropriate. The Perception of Teasing Scale (POTS) was incorporated to measure perceptions of distress where participants were asked to rate the degree to which they were upset by the teasing on a 3-point Likert scale ranging from 1 (not upset) to 3 (very upset), modified from the original The POTS was originally developed with adults and has been used extensively with children and adolescents.

  9-12 month follow up

• Rosenberg Self-Esteem Scale

  A 10-item scale that measures global self-esteem by measuring both positive and negative feelings about the self. Items were modified to be developmentally appropriate for children. Example items include "I like myself" and "I feel there are a lot of good things about me." The scale is uni-dimensional. All items are answered using a 4-point Likert scale format ranging from "strongly agree" to "strongly disagree." In this study, children were also given the option of selecting "I don't want to answer." All items from this scale were used in the pilot study.

  Baseline

• Rosenberg Self-Esteem Scale

  A 10-item scale that measures global self-esteem by measuring both positive and negative feelings about the self. Items were modified to be developmentally appropriate for children. Example items include "I like myself" and "I feel there are a lot of good things about me." The scale is uni-dimensional. All items are answered using a 4-point Likert scale format ranging from "strongly agree" to "strongly disagree." In this study, children were also given the option of selecting "I don't want to answer." All items from this scale were used in the pilot study.

  6 weeks after baseline

• Rosenberg Self-Esteem Scale

  A 10-item scale that measures global self-esteem by measuring both positive and negative feelings about the self. Items were modified to be developmentally appropriate for children. Example items include "I like myself" and "I feel there are a lot of good things about me." The scale is uni-dimensional. All items are answered using a 4-point Likert scale format ranging from "strongly agree" to "strongly disagree." In this study, children were also given the option of selecting "I don't want to answer." All items from this scale were used in the pilot study.

  9-12 month follow up

Secondary Outcomes (12)

• Teacher Satisfaction Scale

  baseline

• Teacher Satisfaction Scale

  6 weeks after baseline

• Fidelity and Adherence Coding

  6 weeks after baseline

• Knowledge Check Test

  baseline

• Knowledge Check Test

  6 weeks after baseline

Study Arms (2)

Intervention Group

EXPERIMENTAL

Educators and students complete a baseline survey. Educators will implement 6 lessons, each 45 minutes, in the classroom. Educators are free to choose the time between lessons, so some can implement all in one week, others can choose to implement once per week. Educators are given a maximum of 6 weeks to implement the curriculum. Educators and students complete a post-program survey. Students complete a 6- and 12-month follow-up survey.

Behavioral: Amazing Me

Control Group

NO INTERVENTION

This group will only complete online surveys that match the time when intervention group is complete the surveys. There is a baseline survey and then a post-survey 6 weeks later for both educators and students. Additionally, students will complete a 6- and 12-month follow-up survey.

Interventions

Amazing Me BEHAVIORAL

The Amazing Me Program is an evidence-based program designed to help children between the ages of 9 and 11 build self-esteem, body confidence, and eliminate weight-based bullying and teasing. This school-based curriculum satisfies national educational health requirements and provides tools for teachers to implement in 4th and 5th grade classrooms.

Intervention Group

Eligibility Criteria

• Age: 9 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Educators teaching 4th and 5th graders. Thus students will be on average between 9 and 11 years old.

You may not qualify if:

• None.

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona State University

Tempe, Arizona, 85287, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A randomized controlled trail will be conducted to ascertain the effectiveness of the Amazing Me intervention in 9-11 year old children. The randomized controlled trial will consist of an intervention and control group. Between 100 to 180 classrooms will be randomized to control or intervention condition. Randomization distribution will be 50%; thus, half of the educators/classrooms will be in the intervention and half in the control. We estimate about 30 students per teacher, yielding a maximum of 2,700 students randomized to intervention and 2,700 students randomized to control. Educators and school districts will be recruited to participate. Educators and students will complete an online baseline survey and another survey after the intervention. Finally, a 6-month and 12-month follow-up survey will be conducted for students.

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 15, 2021
• Study Start: March 12, 2021
• Primary Completion: June 28, 2022
• Study Completion: December 31, 2022
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)