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Helping All Children be Safe Outdoors With Sun Protection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02376517
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : September 17, 2015
Sponsor:
Information provided by (Responsible Party):
June Robinson, Northwestern University

Brief Summary:
The purpose of this study is to test the effectiveness of a sun protection education program for children of all ethnic and racial backgrounds. Practicing sun protection in childhood can reduce the likelihood of developing skin cancer as an adult. The educational program consists of a read-along book in English and Spanish for the child to read with the parent or caregiver, text message reminders to practice sun protection, and a sun protective swim shirt for the child.

Condition or disease Intervention/treatment Phase
Children Parents Sun Protection Behavioral: Educational program Not Applicable

Detailed Description:

Melanoma is the third most common form of cancer in adolescents and young adults in the United States. Unprotected sun exposure, particularly during childhood, is an important contributing factor in the risk of developing melanoma later in life. Targeting 2-6 year old children for primary prevention of skin cancer will minimize sun damage and may foster lifelong sun-protective behaviors that will reduce the likelihood of developing skin cancer, especially melanoma. Parental beliefs about and involvement in sun protection are important components of successful skin cancer prevention programs for children, especially young children.

This is a 12-week summer pilot study. The research seeks to develop a multicomponent sun protection program that is feasible for family practice and pediatric clinicians to introduce with anticipatory guidance during well-child visits. The program will further be implemented through a sun protection read-along book in English and Spanish and weekly text message reminders.

The sun protection program will enable behavioral change by caregivers and children of all ethnic and racial backgrounds. Testing the feasibility of delivering the intervention in a family medicine or pediatric practice will allow assessment of accrual and retention rates in a racially/ethnically diverse population, and lead the way to dissemination of good practice.

Participant in this study will be asked to complete two in-person visits at an Advocate Medical Group pediatric clinic. These visits will take place over a four to six week period. The first visit, or Baseline, may be on the same day as the child's well-visit. The second visit, or Follow-Up, will take place at the same location as the Baseline.

Participants randomized to the intervention group will receive the educational program at Baseline, whereas participants in the control group will receive the educational program during Follow-Up.

At the first visit (Baseline), the participant will:

  1. Complete an anonymous short self-administered questionnaire about knowledge of sun protection and the child's sun protection habits
  2. Some participants will be asked to complete a survey about cultural affiliation.
  3. Receive the educational program at the first visit if randomized to the intervention group.

At the second visit (Follow-Up), the participant will:

  1. Complete an anonymous short self-administered questionnaire about knowledge of sun protection and the child's sun protection habits.
  2. Receive the educational program at the second visit if randomized to the control group.

At the end of each visit, the amount of melanin (pigment) in the child's skin will be measured. This involves the use of a Mexameter, a device that lightly presses on the child's arm to take a reading (picture) of how much pigment there is in his/her skin. This is neither painful nor invasive.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Helping All Children be Safe Outdoors With Sun Protection
Study Start Date : May 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015

Arm Intervention/treatment
Active Comparator: Educational program
Participants randomized to the intervention group will receive the educational program at the baseline visit.
Behavioral: Educational program
The educational program consists of a short (13 pages) read-along book in English and Spanish. This book presents sun protective practices at an appropriate level for 2-6 year old children to read with their parent or caregiver. A sun protective swim shirt, which provides a sun-protection factor (SPF) of over 50, for the child will be provided. Additionally, the parent will receive weekly text message reminders to practice sun protection.

No Intervention: Control
Participants randomized to the control group will receive the educational program at the follow-up visit.



Primary Outcome Measures :
  1. Change from Baseline Melanin Index at 4-6 weeks [ Time Frame: Baseline and 4-6 Weeks ]
    The use of sun protection in those receiving the intervention versus the control group will be examined for correlation with melanin index of child's arm at the baseline and 4-6 week follow-up visit. Spectrophotometer measurement is the wavelength of the reflected light measured in nm. It represents the area under the curve for the all wavelengths of light, thus a reading will be expressed as (192 ±30, mean ± SD).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are at least 18 years old
  • Is the parent of a 2-6 year old child attending a well-child visit
  • If the parent present is female, she may be pregnant
  • Are able to read in English and/or Spanish at a 6th grade level or higher
  • Are able to receive text messages

Exclusion Criteria:

  • Is the parent of a child less than 2 or older than 6 years old attending a visit
  • Unable to read in English and/or Spanish at a 6th grade level or higher
  • Unable to receive text messages
  • Unable to complete study procedures with eligible child
  • Unable to return to clinic for a follow-up visit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376517


Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine Department of Dermatology
Chicago, Illinois, United States, 60611
Advocate Medical Group - Pediatric Clinics
Park Ridge, Illinois, United States, 60068
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: June K Robinson, MD Northwestern University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: June Robinson, Professor of Dermatology, Northwestern University
ClinicalTrials.gov Identifier: NCT02376517    
Other Study ID Numbers: STU00200215
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: September 17, 2015
Last Verified: September 2015
Keywords provided by June Robinson, Northwestern University:
Health Behavior
Melanin Index
Spectrophotometry
Sun Protective Clothing
Education
Primary Prevention