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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02835807
Other study ID # 0301
Secondary ID 5R01CA192652
Status Completed
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date May 31, 2022

Study information

Verified date October 2022
Source Klein Buendel, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A sample of mothers in Tennessee are recruited to a group-randomized pretest-posttest controlled trial evaluating the effect of a social media campaign to decrease mothers' permissiveness for daughters to indoor tan. The primary outcomes is mothers' permissiveness for indoor tanning by daughters. Secondary outcomes are mother's indoor tanning prevalence and their support for stricter bans on indoor tanning by minors.


Description:

Indoor tanning (IT) elevates the risk for melanoma, which is now the most common cancer in women aged 25-29. To reduce melanoma morbidity and mortality, some states have issued complete bans on IT by minors, while others require parental permission for minors to indoor tan. Unfortunately, parental consent policies have suffered from low compliance due to industry non-compliance,likely due to insufficient policy enforcement, and parents' lack of awareness of the dangers of IT. Little attention has been paid to creating health communication that maximizes the effectiveness of IT policy, including both parental consent and bans. Mothers are an important target, because their permissiveness and IT behavior are strong predictors of daughters' IT. Teen girls often initiate IT with their mothers. and further, girls who first experience IT with their mothers begin at an earlier age, become more habitual tanners, and are more resistant to change.Thus, mothers of teen girls are a significant target for interventions to reduce IT and an effective campaign for mothers has the potential to reduce the prevalence of IT in adolescent girls and the incidence of melanoma in young women. Recent research indicates that well-crafted communication can reduce maternal permissiveness but such communication has not been tested as a strategy specifically for maximizing IT policies. A campaign that aims to a) inform mothers of IT risks b) highlight how their IT permissiveness will influence their child's current and future risks,and c) provide them with effective messages to convince daughters not to indoor tan will be developed and delivered via Facebook to maximize the effectiveness of parental-permission laws, the most prevalent IT policy in the United States. The campaign will be evaluated in a group-randomized pretest-posttest controlled trial that enrolls mothers and adolescent teen daughters aged 14 to 17 years old. Participants will be randomized to receive entry into one of two private Facebook groups that will deliver health campaigns lasting one year. In the intervention group, participants will receive a health-focused feed in which 25% of posts are focused on IT. In the control condition, participants will receive the same health-focused feed but instead of 25% of posts focused on IT, 25% of posts will focus on prescription drug abuse and misuse. Randomization will occur at the level of the Facebook private groups; 30-50 mothers from the same community will participate in each Facebook private group for a total of 50 Facebook groups recruited over the trial period. Assessment points will occur at baseline and again at 6-months and 1-year post-intervention. The primary outcome will be reduction in mothers' permissiveness regarding their teen daughter's use of indoor tanning and secondary outcomes will be increase in teen daughters' perception of their mother's permissiveness,and reduction in IT by both mothers and daughters.


Recruitment information / eligibility

Status Completed
Enrollment 1607
Est. completion date May 31, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria (Mothers): - Live in Tennessee - Have a daughter aged 14 to 17 - Register for the social media campaign - Consent to participate - Read English - Complete the online baseline survey - Daughter provides assent to participate - Have a Facebook account or be willing to create one Exclusion Criteria (Mothers): - Not reading English - Living outside Tennessee - Daughter not assenting to participate Inclusion Criteria (Daughters) - Age 14-17 - Provide assent for mother to participate

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Health Chat including Indoor Tanning
Participants in the intervention join a private Facebook group to participate in the Health Chat program. The group is not viewable to the public, including other Facebook users. The content of Health Chat is designed primarily for mothers, the participants in the group. Posts will occur twice daily for 12 months for a total of 720 posts. Each group will be hosted by a moderator who is responsible for managing the intervention goals and mothers' engagement. Mothers likely will not continuously engage with a social media campaign that is limited only to indoor tanning. To engage mothers in the Health Chat program, content addressing several major health and wellness topics relevant to adolescent girls and their mothers will be posted.
Health Chat excluding Indoor Tanning
In the comparison condition, 25% of the posts will be about prescription drug abuse and misuse. Prescription drug abuse was selected as control content because it is a) completely unrelated to tanning, and b) an emerging issue of great interest and relevance to young adults in east Tennessee. This 25% segment of posts is the only difference between the intervention and comparison conditions.

Locations

Country Name City State
United States Colorado State University Fort Collins Colorado
United States Klein Buendel, Inc. Golden Colorado
United States East Tennessee State University Johnson City Tennessee
United States University of Connecticut Storrs Connecticut

Sponsors (5)

Lead Sponsor Collaborator
Klein Buendel, Inc. Colorado State University, East Tennessee State University, National Cancer Institute (NCI), University of Connecticut

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Mothers' Permissiveness for Daughters to Indoor Tan Mothers' permissiveness for daughters to indoor tan will be assessed using 6 Likert-type items (1=strongly disagree, 5=strongly agree) assessing permissiveness toward their teenage daughter's indoor tanning. Example items include, "I would allow my daughter to indoor tan," and "I think it's OK for my daughter to indoor tan." Daughters will be asked the same 6 items to assess their perceptions of mothers' permissiveness. This measure has been used with a national teen sample. Maternal permissiveness will be assessed at baseline and both follow-ups by the combined average ratings across the six items. Baseline, 6-month, and 1 year follow-up
Secondary Change in Mothers' Indoor Tanning Prevalence Prevalence of indoor tanning will be assessed by asking mothers to report on their indoor tanning behavior using a single open-ended item, i.e., "How many times between December 1, 2015 and March 31, 2016 have you used a tanning bed or booth?" The December to March period was selected to control for seasonality; indoor tanning is most frequent during winter and early spring. In addition, intention to indoor tan will be assessed, i.e., How likely is it that you will indoor tan in the next 3 months/6 months/12 months (7-point Likert response scale), along with intention to get a sunless tanning treatment in the next 12 months. Indoor tanning prevalence and intentions will be assessed at baseline and both follow-ups. Baseline, 6-month, and 1 year follow-up
Secondary Change in Daughters' Indoor Tanning Prevalence Prevalence of indoor tanning will be assessed by asking daughters to report on their indoor tanning behavior using a single open-ended item, i.e., "How many times between December 1, 2015 and March 31, 2016 have you used a tanning bed or booth?" The December to March period was selected to control for seasonality; indoor tanning is most frequent during winter and early spring. In addition, intention to indoor tan will be assessed, i.e., How likely is it that you will indoor tan in the next 3 months/6 months/12 months (7-point Likert response scale), along with intention to get a sunless tanning treatment in the next 12 months. Indoor tanning prevalence and intentions will be assessed at baseline and both follow-ups. Baseline, 6-month, and 1 year follow-up
Secondary Mothers' Support for Stricter Bans on Indoor Tanning by Minors Support for strengthening bans on indoor tanning (IT) by minors will be measured via the web server which will record whether mothers click on the link to "sign" the petition to strengthen the ban on indoor tanning and forward it to their legislator. 13-months after randomization
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