## Protocol Section
### Identification Module
**NCT ID:** NCT02469779

**Brief Title:** Middle and High School Students' Reactions to a Health Interactive Website: ASPIRE Reactions

**Official Title:** Middle and High School Students' Reactions to a Health Interactive Website: ASPIRE Reactions

#### Organization Study ID Info
**ID:** 2013-0296
#### Organization
**Class:** OTHER
**Full Name:** M.D. Anderson Cancer Center
### Status Module
#### Completion Date
**Date:** 2021-02-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-02-08

**Type:** ACTUAL

**Last Update Submit Date:** 2021-02-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-02-01

**Type:** ACTUAL

#### Start Date
**Date:** 2013-12

**Type:** ACTUAL

**Status Verified Date:** 2021-02

#### Study First Post Date
**Date:** 2015-06-11
**Type:** ESTIMATED
**Study First Submit Date:** 2015-06-09
**Study First Submit QC Date:** 2015-06-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institutes of Health (NIH)

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** OTHER

**Name:** M.D. Anderson Cancer Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The goal of this research study is to learn how middle and high school students react to an interactive website called ASPIRE ( A Smoking Prevention Interactive Experience) and health information online and what their preferences are when using ASPIRE.

Researchers hope to use the results of this study to design more effective online health programs to provide middle and high school students with up-to-date information about tobacco use, meditation, and general health and well-being.

**Detailed Description:** Participants complete up to 2 separate parts.

Part 1:

For Part 1, participants complete a survey about their mental and physical health and their opinions concerning health information and the internet. The survey takes about 15-20 minutes to complete.

Part 2:

If the results of the survey show eligibility, participants complete Part 2 of the study. For Part 2 participants are randomly assigned (as in a roll of dice) to 1 of 2 study groups. Participants have a 1 in 3 chance of being assigned to receive standard care. Participants have a 2 in 3 chance of being assigned to use the ASPIRE website. This is done because no one knows if one study group is better, the same, or worse than the other group.

If participant assigned to receive standard care, he or she is shown a website that has the same information presented in ASPIRE, but in text form.

Participants in both groups sit in front of a computer and go onto a website. Both the ASPIRE website and the text-based website have been designed for middle and high school students. The ASPIRE website has videos, activities, and health information facts about the effects of smoking, the benefits of meditation, and healthy living. The text-based website only has health information facts about smoking, the benefits of meditation, and healthy living. Participants complete 3 to 4 sessions using either the ASPIRE website or the text-based website throughout their first semester. Each session lasts about 40 minutes.

The use of the websites will be videotaped.

Follow-Up Surveys:

Participants complete a follow-up survey about their opinions concerning health information and the internet immediately after they complete their last session on the website. The follow-up surveys take about 15 minutes to complete.

Length of Study:

Active participation on this study is over after participants complete the follow-up survey. If participant does not continue onto Part 2 of the study, their active participation is over after they complete Part 1 of the study.

Other Information:

Participants take part in this study at their school during their after school program.

During the use of the website, each study participant is individually videotaped and audio recorded. The videotapes and audio recordings are used to help the research staff analyze each participant's use of the websites. The video tapes and audio recordings are stored on a password-protected encrypted hard drive that is stored in a locked office at MD Anderson. Only the study researcher and authorized members of the research staff are allowed to use the videotapes and audio recordings (for research purposes).

### Conditions Module

**Conditions:**

- Tobacco Use Cessation

- Tobacco Prevention

**Keywords:**

- Tobacco Prevention

- ASPIRE Website

- Surveys

- Questionnaires

- Focus Groups

- Health Interactive Website

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 700

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants complete baseline survey. Participants view the ASPIRE website containing videos, activities, and health information facts about the effects of smoking, the benefits of meditation, and healthy living. This viewing will be videotaped and audio recorded. 3 to 4 sessions will be completed. After each website session, survey will be completed.

**Intervention Names:**

- Behavioral: Surveys

- Behavioral: ASPIRE Website

- Behavioral: Follow Up Survey

**Label:** ASPIRE Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants complete baseline survey. Participants view the ASPIRE text-based website containing health information facts about smoking, the benefits of meditation, and healthy living. This viewing will be videotaped and audio recorded. 3 to 4 sessions will be completed. After each website session, survey will be completed.

**Intervention Names:**

- Behavioral: Surveys

- Behavioral: ASPIRE Text-Based Website

- Behavioral: Follow Up Survey

**Label:** Control Group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ASPIRE Group

- Control Group

**Description:** At baseline participants complete survey about their mental and physical health and their opinions concerning health information and the internet. The survey will take about 15-20 minutes to complete.

**Name:** Surveys

**Other Names:**

- Questionnaires

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- ASPIRE Group

**Description:** Participants view the ASPIRE website containing videos, activities, and health information facts about the effects of smoking, the benefits of meditation, and healthy living. This viewing will be videotaped

**Name:** ASPIRE Website

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- Control Group

**Description:** Participants view the ASPIRE text-based website containing health information facts about smoking, the benefits of meditation, and healthy living.

**Name:** ASPIRE Text-Based Website

**Type:** BEHAVIORAL

#### Intervention 4

**Arm Group Labels:**

- ASPIRE Group

- Control Group

**Description:** Participants complete a follow-up survey about their opinions concerning health information and the internet immediately after they have completed their last session on the website.

**Name:** Follow Up Survey

**Other Names:**

- Questionnaire

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** This outcome is measured using the validated susceptibility to smoke scale in a Likert scale format and baseline and immediate follow up.

**Measure:** Intention to Smoke

**Time Frame:** 1 day

#### Secondary Outcomes

**Description:** Outcome measured using validated Likert scales. In addition, facial expressions of happiness, sadness, disgust, fear, anger, and surprise are measured using a software program of emotion recognition for facial movement. The software captures the extent of expression of each of the emotions on a scale from 0 to 1.

**Measure:** Emotional Response

**Time Frame:** 4 days

**Description:** Participants' reported qualitatively attributes (i.e. features) in ASPIRE that they recall to be emotionally involving. This report conducted using open-ended questions.

**Measure:** Participants' Reported Qualitatively Attributes in ASPIRE

**Time Frame:** 1 day

**Description:** Generation of emotional expression during use of ASPIRE is dependent on data for use of ASPIRE features, and data for emotional expression. Recorded videos of participant's online behavior analyzed via manual content analysis. Recorded videos of online behavior (i.e. mouse movement on the screen, clicking, dragging behaviors, and what the webpage presents) also analyzed using N-vivo.

**Measure:** Relationship Between Emotional Involvement During Use of ASPIRE Website and Change in Susceptibility to Smoking

**Time Frame:** 1 day

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Ages 11 through 18 (11 and 18 included)
2. High school and Middle School students are both eligible
3. All 150 are nonsmokers. Nonsmokers are defined as individuals who have not smoked, not even part of a cigarette in the past year.
4. All will score above the median on smoking susceptibility
5. 10 will be White/Caucasian participants, 5 will be African American participants, 10 will be Hispanic participants, and 5 will be Asian participants.
6. English speaking

Exclusion Criteria:

1)None

**Healthy Volunteers:** True

**Maximum Age:** 18 Years

**Minimum Age:** 11 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Houston

**Country:** United States

**Facility:** Mt. Calvary Baptist Church

**State:** Texas

**Zip:** 77008

**Location 2:**

**City:** Houston

**Country:** United States

**Facility:** Young Men's Christian Association (YMCA)

**State:** Texas

**Zip:** 77253

#### Overall Officials

**Official 1:**

**Affiliation:** M.D. Anderson Cancer Center

**Name:** Alex Prokhorov, MD, PHD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Khalil GE, Wang H, Calabro KS, Mitra N, Shegog R, Prokhorov AV. From the Experience of Interactivity and Entertainment to Lower Intention to Smoke: A Randomized Controlled Trial and Path Analysis of a Web-Based Smoking Prevention Program for Adolescents. J Med Internet Res. 2017 Feb 16;19(2):e44. doi: 10.2196/jmir.7174.

**PMID:** 28209560

#### See Also Links

**Label:** University of Texas MD Anderson Cancer Center Website

**URL:** http://www.mdanderson.org

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
